Trial Outcomes & Findings for Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens (NCT NCT03633695)
NCT ID: NCT03633695
Last Updated: 2022-10-24
Results Overview
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
453 participants
Primary outcome timeframe
6 Months (160-210 days post second eye operative visit)
Results posted on
2022-10-24
Participant Flow
Subjects were recruited from 21 investigative sites within the United States from 04 December 2018 to 21 August 2019. The investigative sites were comprised of similar clinic, surgical center, and equipment requirements necessary for the intended use of the IC-8™ IOL.
A total of 548 subjects signed the informed consent form, 79 of whom did not meet inclusion/exclusion criteria and were considered screen failures; leaving 469 subjects who were considered provisionally enrolled in the study. A total of 16 subjects were disqualified or discontinued from the study prior to second eye implantation. There were 453 subjects who were successfully bilaterally implanted in the study (reporting group).
Unit of analysis: Eyes
Participant milestones
| Measure |
IC-8™ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
* Subjects in this Group were assigned to Astigmatism Group 1 (\<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (study eye).
|
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
* Subjects in this Group were assigned to Astigmatism Group 1 (\<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (fellow eye).
|
|---|---|---|
|
Overall Study
STARTED
|
343 686
|
110 220
|
|
Overall Study
Astigmatism Group 1 (IC-8™ IOL Group)
|
273 546
|
0 0
|
|
Overall Study
Astigmatism Group 2 (IC-8™ IOL Group)
|
70 140
|
0 0
|
|
Overall Study
Astigmatism Group 1 (Control Group)
|
0 0
|
91 182
|
|
Overall Study
Astigmatism Group 2 (Control Group)
|
0 0
|
19 38
|
|
Overall Study
COMPLETED
|
331 662
|
101 202
|
|
Overall Study
NOT COMPLETED
|
12 24
|
9 18
|
Reasons for withdrawal
| Measure |
IC-8™ IOL Group
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
* Subjects in this Group were assigned to Astigmatism Group 1 (\<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (study eye).
|
Control Group
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
* Subjects in this Group were assigned to Astigmatism Group 1 (\<1.0 D) or Astigmatism Group 2 (1.0 D - 1.5 D), as determined by preoperative corneal astigmatism in the 2nd eye (fellow eye).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
5
|
|
Overall Study
Discontinued
|
8
|
4
|
Baseline Characteristics
Clinical Evaluation of a Small Aperture Extended Depth of Focus Intraocular Lens
Baseline characteristics by cohort
| Measure |
IC-8™ IOL Group
n=343 Participants
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=110 Participants
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 Years
STANDARD_DEVIATION 7.96 • n=99 Participants
|
69.1 Years
STANDARD_DEVIATION 8.63 • n=107 Participants
|
66.8 Years
STANDARD_DEVIATION 8.22 • n=206 Participants
|
|
Sex: Female, Male
Female
|
211 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
166 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
320 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
420 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
311 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
410 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Preoperative Corneal Astigmatism
Astigmatism Group 1 (<1.0 D)
|
273 Participants
n=99 Participants
|
91 Participants
n=107 Participants
|
364 Participants
n=206 Participants
|
|
Preoperative Corneal Astigmatism
Astigmatism Group 2 (1.0 D - 1.5 D)
|
70 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 66 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Outcome measures
| Measure |
IC-8™ IOL Group
n=670 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=200 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Binocular Photopic Uncorrected Intermediate (66 cm) Visual Acuity (UCIVA)
|
0.051 logMAR
Standard Deviation 0.1629
|
0.228 logMAR
Standard Deviation 0.1646
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 40 cm, without manifest refraction, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Outcome measures
| Measure |
IC-8™ IOL Group
n=670 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=200 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Binocular Photopic Uncorrected Near (40 cm) Visual Acuity (UCNVA)
|
0.186 logMAR
Standard Deviation 0.1425
|
0.377 logMAR
Standard Deviation 0.1576
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Visual acuity (VA) was tested binocularly (both eyes) at a distance of 4 m, with +0.25 D infinity adjustment lens in front of the eyes, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Outcome measures
| Measure |
IC-8™ IOL Group
n=670 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=200 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Binocular Photopic Uncorrected Distance (4 m) Visual Acuity (UCDVA)
|
-0.010 logMAR
Standard Deviation 0.1063
|
0.002 logMAR
Standard Deviation 0.0992
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 6 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Visual acuity (VA) was tested monocularly (each eye) at a distance of 66 cm, with the distance manifest refraction (with infinity adjustment) in place for that eye, using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Outcome measures
| Measure |
IC-8™ IOL Group
n=335 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=335 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Monocular Photopic Distance-Corrected Intermediate (66 cm) Visual Acuity (DCIVA) in IC-8™ IOL Eyes
|
0.144 logMAR
Standard Deviation 0.1709
|
0.325 logMAR
Standard Deviation 0.1687
|
—
|
—
|
PRIMARY outcome
Timeframe: 3 Months (60-110 days post second eye operative visit)Population: For this outcome measure, the number of participants/eyes from the Intent-to-Treat (ITT) population (all subjects who were fully enrolled and were binocularly implanted in the study) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Depth of focus was performed monocularly in the IC-8™ IOL Group at the far to near range of vision (+2.00 to -5.00 D), using 100% contrast ETDRS charts in a computerized testing system calibrated for a 4 m test distance, with manifest refraction (no infinity adjustment) in place for the eye(s) being tested. The defocus power was progressively introduced in 0.50 D increments from +2.00 D to +0.50 D and from -0.50 D to -5.00 D, then in 0.25 D increments from +0.50 D to -0.50 D, while visual acuity was measured at each successive defocus step. The depth of focus was estimated as the defocus range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation.
Outcome measures
| Measure |
IC-8™ IOL Group
n=335 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=335 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Monocular Photopic Depth of Focus (DOF) in IC-8™ IOL Eyes
|
-1.99 Diopter
Standard Deviation NA
The negative intercept (outcome measure) was calculated from the means of the two defocus steps where the defocus curve crosses the 0.2 logMAR threshold.
|
-1.08 Diopter
Standard Deviation NA
The negative intercept (outcome measure) was calculated from the means of the two defocus steps where the defocus curve crosses the 0.2 logMAR threshold.
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Outcome measures
| Measure |
IC-8™ IOL Group
n=331 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=331 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Monocular Best-corrected Distance (4 m) Visual Acuity (BCDVA)
|
0.009 logMAR
Standard Deviation 0.1131
|
-0.059 logMAR
Standard Deviation 0.0928
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart.
Outcome measures
| Measure |
IC-8™ IOL Group
n=331 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=331 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Proportion of IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
|
326 Eyes
|
330 Eyes
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the Best-Case analysis was used, which, included subjects with no preoperative ocular pathology, no macular degeneration detected at any time, and no previous surgery for the correction of refractive errors (as defined by ISO 11979-1:2012), as well as no significant macular pathology at any time. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Visual acuity (VA) was tested monocularly (each eye) at a distance of 4 m, in photopic conditions, with manifest refraction in place (no infinity adjustment) using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart presenting on a self-calibrating monitor in a computerized testing system. Visual acuity was measured in logarithm of the minimum angle of resolution (logMAR), with a 0.02 logMAR increment corresponding to a single letter on the ETDRS chart. Monocular BCDVA for the IC-8™ IOL eyes of subjects in the Best-Case population was compared to the safety and performance endpoints (SPE) rate for posterior chamber IOLs.
Outcome measures
| Measure |
IC-8™ IOL Group
n=319 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=319 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Proportion of Best-Case IC-8™ IOL Eyes Achieving Best-corrected Distance Visual Acuity (BCDVA) 0.3 logMAR or Better Compared to the Safety and Performance Endpoints (SPE) Rates
|
315 Eyes
|
318 Eyes
|
—
|
—
|
PRIMARY outcome
Timeframe: Through 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
The rates of cumulative ocular serious adverse events (SAEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Outcome measures
| Measure |
IC-8™ IOL Group
n=343 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=343 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Cystoid Macular Edema
|
5 Eyes
|
4 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Hypopyon
|
0 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Endophthalmitis
|
1 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Lens Dislocated from Posterior Chamber
|
0 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Pupillary Block
|
0 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Retinal Detachment
|
0 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Modified Paracentesis
|
4 Eyes
|
3 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Intravitreal Injection
|
1 Eyes
|
1 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Laser Retinopexy
|
0 Eyes
|
1 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Other: Retinal Vein Occlusion
|
1 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Vitrectomy
|
4 Eyes
|
1 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
Removal of retained cortex
|
2 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Cumulative Ocular Serious Adverse Events
IOL repositioning
|
1 Eyes
|
1 Eyes
|
—
|
—
|
PRIMARY outcome
Timeframe: Through 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Outcome measures
| Measure |
IC-8™ IOL Group
n=343 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=343 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
n=110 Eyes
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
n=110 Eyes
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Intravitreal Injection
|
1 Eyes
|
1 Eyes
|
0 Eyes
|
1 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
IOL Exchange
|
0 Eyes
|
0 Eyes
|
1 Eyes
|
1 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
IOL Repositioning
|
1 Eyes
|
1 Eyes
|
0 Eyes
|
1 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Iris Reposition
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
1 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Laser Retinopexy
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Laser Vitreolysis
|
0 Eyes
|
0 Eyes
|
1 Eyes
|
0 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Modified Paracentesis
|
4 Eyes
|
3 Eyes
|
0 Eyes
|
1 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Removal of Retained Cortex
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Rates of IC-8™ IOL Eyes With Cumulative Postoperative Ocular Adverse Events (Secondary Surgical Interventions)
Vitrectomy
|
4 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
PRIMARY outcome
Timeframe: Through 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
The rates of persistent (defined as being unresolved at final scheduled visit) ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Outcome measures
| Measure |
IC-8™ IOL Group
n=331 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=331 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
Corneal Stromal Edema
|
0 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
Cystoid Macular Edema
|
1 Eyes
|
1 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
Iritis
|
2 Eyes
|
1 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
Raised IOP Requiring Treatment
|
0 Eyes
|
0 Eyes
|
—
|
—
|
|
Rates of IC-8™ IOL Eyes With Persistent Ocular Serious Adverse Events
Other: Retinal Vein Occlusion
|
1 Eyes
|
0 Eyes
|
—
|
—
|
PRIMARY outcome
Timeframe: Through 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
The rates of cumulative ocular adverse events for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Outcome measures
| Measure |
IC-8™ IOL Group
n=343 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=343 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
n=110 Eyes
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
n=110 Eyes
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Rates of IC-8™ IOL Eyes With IC-8™ IOL Removals
|
0 Eyes
|
0 Eyes
|
1 Eyes
|
1 Eyes
|
PRIMARY outcome
Timeframe: Through 12 Months (300-420 days post second eye operative visit)Population: For this outcome measure, the safety analysis set was used, which, included available data from all eyes that were bilaterally implanted, or for whom implantation of an IC-8™ IOL was attempted (the IC-8 IOL touched the eye during surgery). The Safety and ITT populations were identical in this study. Data from participants/eyes available for analysis at 12 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
The rates of cumulative ocular adverse events (AEs) for IC-8™ IOL eyes were calculated from the time of second eye (IC-8™ IOL eye) implantation through Month 12.
Outcome measures
| Measure |
IC-8™ IOL Group
n=343 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=343 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
n=110 Eyes
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
n=110 Eyes
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Vision Blurred
|
2 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
|
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Device Damage
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
|
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Posterior Capsule Opacification
|
3 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
|
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Altered Visual Depth Perception
|
1 Eyes
|
1 Eyes
|
0 Eyes
|
0 Eyes
|
|
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Dysphotopsia
|
5 Eyes
|
3 Eyes
|
0 Eyes
|
1 Eyes
|
|
Rates of Eyes With Postoperative Ocular Adverse Events (Other Than Secondary Surgical Intervention), Related to Device (Serious and Non-Serious Combined)
Halo Vision
|
2 Eyes
|
0 Eyes
|
0 Eyes
|
0 Eyes
|
SECONDARY outcome
Timeframe: 3 Months (60-110 days post second eye operative visit)Population: For this outcome measure, the number of participants/eyes from the modified Intent-to-Treat (mITT) population (subjects from the intent to treat population that achieved BCDVA 20/25 or better) that were available for analysis at 3 Months was used. It was pre-specified that results were not separated by Astigmatism Groups for this measure.
Uncorrected-distance visual acuity (UCDVA) in IC-8™ IOL eyes achieving best-corrected distance visual acuity (BCDVA) of 20/25 or better was compared between eyes with preoperative corneal astigmatism \< 1.0 D to eyes with 1.0 D to 1.5 D of preoperative corneal astigmatism.
Outcome measures
| Measure |
IC-8™ IOL Group
n=244 Eyes
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=65 Eyes
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Tolerance to Preoperative Corneal Astigmatism in IC-8™ IOL Eyes With BCDVA 20/25 at 3 Months
|
0.085 logMAR
Standard Deviation 0.1269
|
0.108 logMAR
Standard Deviation 0.1208
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better contrast sensitivity results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 log units
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=260 log units
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Monocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 3 cpd
|
1.935 log units on a scale
Standard Deviation 0.3768
|
2.202 log units on a scale
Standard Deviation 0.2542
|
—
|
—
|
|
Mean Monocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 6 cpd
|
1.795 log units on a scale
Standard Deviation 0.3736
|
2.055 log units on a scale
Standard Deviation 0.3576
|
—
|
—
|
|
Mean Monocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 12 cpd
|
1.308 log units on a scale
Standard Deviation 0.4186
|
1.554 log units on a scale
Standard Deviation 0.4530
|
—
|
—
|
|
Mean Monocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 18 cpd
|
0.832 log units on a scale
Standard Deviation 0.3996
|
1.072 log units on a scale
Standard Deviation 0.4220
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects, and was tested monocularly (each eye) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 Participants
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=260 Participants
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Monocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 3 cpd
|
1.620 log units on a scale
Standard Deviation 0.4219
|
1.822 log units on a scale
Standard Deviation 0.4247
|
—
|
—
|
|
Mean Monocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 6 cpd
|
1.513 log units on a scale
Standard Deviation 0.3926
|
1.747 log units on a scale
Standard Deviation 0.4136
|
—
|
—
|
|
Mean Monocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 12 cpd
|
1.106 log units on a scale
Standard Deviation 0.4149
|
1.345 log units on a scale
Standard Deviation 0.4315
|
—
|
—
|
|
Mean Monocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 18 cpd
|
0.659 log units on a scale
Standard Deviation 0.4161
|
0.887 log units on a scale
Standard Deviation 0.4171
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 log units
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=260 log units
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 1.5 cpd
|
1.385 log units on a scale
Standard Deviation 0.3596
|
1.850 log units on a scale
Standard Deviation 0.3849
|
—
|
—
|
|
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 3 cpd
|
1.475 log units on a scale
Standard Deviation 0.3882
|
1.964 log units on a scale
Standard Deviation 0.3662
|
—
|
—
|
|
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 6 cpd
|
1.217 log units on a scale
Standard Deviation 0.3901
|
1.609 log units on a scale
Standard Deviation 0.4300
|
—
|
—
|
|
Mean Monocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 12 cpd
|
0.620 log units on a scale
Standard Deviation 0.3739
|
0.913 log units on a scale
Standard Deviation 0.4105
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested monocularly (each eye) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 log units
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=260 log units
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Monocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 1.5 cpd
|
1.044 log units on a scale
Standard Deviation 0.4063
|
1.338 log units on a scale
Standard Deviation 0.4212
|
—
|
—
|
|
Mean Monocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 3 cpd
|
1.201 log units on a scale
Standard Deviation 0.4142
|
1.552 log units on a scale
Standard Deviation 0.4468
|
—
|
—
|
|
Mean Monocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 6 cpd
|
1.035 log units on a scale
Standard Deviation 0.4337
|
1.353 log units on a scale
Standard Deviation 0.4224
|
—
|
—
|
|
Mean Monocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 12 cpd
|
0.496 log units on a scale
Standard Deviation 0.3886
|
0.749 log units on a scale
Standard Deviation 0.4305
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, without a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 log units
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=67 log units
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Binocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 3 cpd
|
2.233 log units on a scale
Standard Deviation 0.2536
|
2.287 log units on a scale
Standard Deviation 0.1896
|
—
|
—
|
|
Mean Binocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 6 cpd
|
2.119 log units on a scale
Standard Deviation 0.3293
|
2.141 log units on a scale
Standard Deviation 0.3177
|
—
|
—
|
|
Mean Binocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 12 cpd
|
1.689 log units on a scale
Standard Deviation 0.4263
|
1.654 log units on a scale
Standard Deviation 0.5124
|
—
|
—
|
|
Mean Binocular Photopic Contrast Sensitivity Without Glare
Spatial Frequency 18 cpd
|
1.164 log units on a scale
Standard Deviation 0.4123
|
1.090 log units on a scale
Standard Deviation 0.4834
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in photopic (well-lit) conditions, with a glare source, using sine waving gratings in a computerized testing system. The photopic spatial frequencies tested were 3, 6, 12, 18 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 log units
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=67 log units
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Binocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 3 cpd
|
1.866 log units on a scale
Standard Deviation 0.3893
|
1.983 log units on a scale
Standard Deviation 0.3217
|
—
|
—
|
|
Mean Binocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 6 cpd
|
1.856 log units on a scale
Standard Deviation 0.3853
|
1.891 log units on a scale
Standard Deviation 0.3745
|
—
|
—
|
|
Mean Binocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 12 cpd
|
1.431 log units on a scale
Standard Deviation 0.4408
|
1.476 log units on a scale
Standard Deviation 0.4720
|
—
|
—
|
|
Mean Binocular Photopic Contrast Sensitivity With Glare
Spatial Frequency 18 cpd
|
0.957 log units on a scale
Standard Deviation 0.4388
|
0.970 log units on a scale
Standard Deviation 0.4516
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, without a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast, the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 log units
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=67 log units
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 1.5 cpd
|
1.936 log units on a scale
Standard Deviation 0.3442
|
1.969 log units on a scale
Standard Deviation 0.4236
|
—
|
—
|
|
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 3 cpd
|
2.030 log units on a scale
Standard Deviation 0.3306
|
2.079 log units on a scale
Standard Deviation 0.3129
|
—
|
—
|
|
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 6 cpd
|
1.688 log units on a scale
Standard Deviation 0.3922
|
1.723 log units on a scale
Standard Deviation 0.4132
|
—
|
—
|
|
Mean Binocular Mesopic Contrast Sensitivity Without Glare
Spatial Frequency 12 cpd
|
0.995 log units on a scale
Standard Deviation 0.4098
|
0.986 log units on a scale
Standard Deviation 0.4300
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Months (160-210 days post second eye operative visit)Population: A subgroup of subjects from the IC-8™ IOL Group (262 enrolled) and Control Group (68 enrolled) available for analysis at 6 Months. It was pre-specified that results were not separated by Astigmatism Groups for this outcome measure.
Contrast sensitivity (the ability to distinguish between an object and it's background) was evaluated in a subgroup of subjects and was tested binocularly (both eyes) in mesopic (low-light) conditions, with a glare source, using sine waving gratings in a computerized testing system. The mesopic spatial frequencies tested were 1.5, 3, 6, 12 cycles per degree (cpd). When a subject was unable to see the highest contrast grating, the highest contrast score was assigned. Raw scores (0 to 9) from contrast sensitivity testing were transformed to log units. Better results are reflected by a higher numeric value.
Outcome measures
| Measure |
IC-8™ IOL Group
n=260 log units
Subjects implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the first eye and the IC-8™ Intraocular Lens (IOL) in the second eye.
|
Control Group
n=67 log units
Subjects bilaterally implanted with monofocal IOLs (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
Second Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
First Eyes (Control Group)
Eyes implanted with a monofocal IOL (AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00), or monofocal toric IOLs (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225).
|
|---|---|---|---|---|
|
Mean Binocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 1.5 cpd
|
1.395 log units on a scale
Standard Deviation 0.4280
|
1.559 log units on a scale
Standard Deviation 0.3979
|
—
|
—
|
|
Mean Binocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 3 cpd
|
1.602 log units on a scale
Standard Deviation 0.4527
|
1.714 log units on a scale
Standard Deviation 0.3955
|
—
|
—
|
|
Mean Binocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 6 cpd
|
1.382 log units on a scale
Standard Deviation 0.4254
|
1.403 log units on a scale
Standard Deviation 0.3575
|
—
|
—
|
|
Mean Binocular Mesopic Contrast Sensitivity With Glare
Spatial Frequency 12 cpd
|
0.797 log units on a scale
Standard Deviation 0.3951
|
0.756 log units on a scale
Standard Deviation 0.4223
|
—
|
—
|
Adverse Events
Preoperative
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
IC-8™ IOL Group - 2nd Eye
Serious events: 6 serious events
Other events: 264 other events
Deaths: 0 deaths
IC-8™ IOL Group - 1st Eye
Serious events: 2 serious events
Other events: 148 other events
Deaths: 0 deaths
IC-8™ IOL Group - Systemic
Serious events: 22 serious events
Other events: 114 other events
Deaths: 0 deaths
Control Group - 2nd Eye
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Control Group - 1st Eye
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Control Group - Systemic
Serious events: 5 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preoperative
n=453 participants at risk
All subjects in the safety analysis population (Intent-to-Treat population) prior to second eye implantation.
|
IC-8™ IOL Group - 2nd Eye
n=343 participants at risk
All second eyes (study eyes) implanted with IC-8™ IOL in the IC-8™ IOL Group.
|
IC-8™ IOL Group - 1st Eye
n=343 participants at risk
All first eyes (fellow eyes) implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the IC-8™ IOL Group.
|
IC-8™ IOL Group - Systemic
n=343 participants at risk
All subjects implanted with the IC-8™ IOL in the IC-8™ IOL Group.
|
Control Group - 2nd Eye
n=110 participants at risk
All second eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
|
Control Group - 1st Eye
n=110 participants at risk
All first eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
|
Control Group - Systemic
n=110 participants at risk
All subjects implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Blood and lymphatic system disorders
Aneursysm
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Arrhythmia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Heart failure/Congestive heart failure
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Ischemic heart disease
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.2%
4/343 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Sepsis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Immune system disorders
Solid tumour
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Spinal column injury
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Transient ischemic attack
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Vomiting
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Cystoid Macular Edema
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Endophthalmitis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Intraocular Pressure Increased
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Iris Injury
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
Other adverse events
| Measure |
Preoperative
n=453 participants at risk
All subjects in the safety analysis population (Intent-to-Treat population) prior to second eye implantation.
|
IC-8™ IOL Group - 2nd Eye
n=343 participants at risk
All second eyes (study eyes) implanted with IC-8™ IOL in the IC-8™ IOL Group.
|
IC-8™ IOL Group - 1st Eye
n=343 participants at risk
All first eyes (fellow eyes) implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the IC-8™ IOL Group.
|
IC-8™ IOL Group - Systemic
n=343 participants at risk
All subjects implanted with the IC-8™ IOL in the IC-8™ IOL Group.
|
Control Group - 2nd Eye
n=110 participants at risk
All second eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
|
Control Group - 1st Eye
n=110 participants at risk
All first eyes implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
|
Control Group - Systemic
n=110 participants at risk
All subjects implanted with an AcrySof® IQ SA60WF or TECNIS® aspheric monofocal ZCB00, or monofocal toric IOL (AcrySof® IQ SA6AT3, SA6AT4 or TECNIS® ZCT150 or ZCT225) in the Control Group.
|
|---|---|---|---|---|---|---|---|
|
General disorders
Abdominal pain
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Abscess
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Hepatobiliary disorders
Acute liver failure
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Altered Visual Depth Perception
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Angioedema
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Anterior Capsular Phimosis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Anxiety
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Arrhythmia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Blood and lymphatic system disorders
Arteriosclerosis/Atherosclerosis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia/Myalgia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Atrial fibrillation
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Surgical and medical procedures
Bradycardia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Immune system disorders
Breast cancer
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm/Asthma
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Brow, Eyelid Ptosis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Immune system disorders
Cancer
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.5%
5/343 • Number of events 5 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Cataract Fragments in Eye Following Cataract Surgery
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Cataract Operation Complication, Lens Dislocation
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Cataract Subcapsular
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Catheterization arterial normal
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Ciliary Zonular Dehiscence, Vitreous Prolapse
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Immune system disorders
Cold sores
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Common cold syndrome
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Conjunctival Edema
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Conjunctival Hemorrhage
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Conjunctival abrasion
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.0%
7/343 • Number of events 7 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.2%
4/343 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Nervous system disorders
Convulsion/Seizure
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Corneal Abrasion
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Corneal Deposits, Cornea Verticillata
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Corneal Dystrophy
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Corneal Epithelial Defect
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Corneal Epithelial Microcysts
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Corneal stromal edema
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Cramp(s)/Muscle spasm(s)
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Cystoid Macular Edema
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Damage to ligament(s)
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Depression
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Detached Descemet's membrane
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Detachment of retinal pigment epithelium, Retinal depigmentation
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Device Damage
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Diplopia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Dizziness
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Dry Eye
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
9.3%
32/343 • Number of events 32 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
7.6%
26/343 • Number of events 26 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
8.2%
9/110 • Number of events 9 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
8.2%
9/110 • Number of events 9 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Dysphotopsia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.5%
5/343 • Number of events 5 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Endocrine disorders
Hepatitis, unspecified
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Encephalopathy
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Eye Irritation
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Eye Pain
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.5%
5/343 • Number of events 5 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
High blood pressure/Hypertension
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.3%
8/343 • Number of events 8 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Eye Pruritus
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Eyelid infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.7%
6/343 • Number of events 6 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Eyelid tumor
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Facial pain
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Flu
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Foreign body in eye
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Fungal infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Gastrointestinal disorders
Gastrointestinal regurgitation
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Giant cell arteritis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Halo Vision
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Headache
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.0%
7/343 • Number of events 7 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
4.5%
5/110 • Number of events 5 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Heart failure/Congestive heart failure
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
High pulmonary arterial wedge pressure
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Hypercholesterolemia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.2%
4/343 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity/Allergic reaction
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Hypertension worsened
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Hypotension
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression or protrusion
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Intraocular pressure increased
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
5.5%
19/343 • Number of events 19 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
4.7%
16/343 • Number of events 16 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
9.1%
10/110 • Number of events 10 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
6.4%
7/110 • Number of events 7 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Iris transillumination defect
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Iritis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
4.4%
15/343 • Number of events 15 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.0%
7/343 • Number of events 7 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
4.5%
5/110 • Number of events 5 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Keratic precipitates
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Low blood pressure/Hypotension
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Immune system disorders
Lyme disease
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Muscle/Tendon damage
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.2%
4/343 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Ocular Discomfort
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Oral bacterial infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Pain
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Peripheral vascular disease NOS
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Phlebitis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Photophobia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Pleural effusion
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyp of nasal cavity
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Posterior Vitreous Detachment
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
5.5%
19/343 • Number of events 19 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.3%
8/343 • Number of events 8 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
3.6%
4/110 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
32.4%
111/343 • Number of events 111 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
14.0%
48/343 • Number of events 48 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
17.3%
19/110 • Number of events 19 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
16.4%
18/110 • Number of events 18 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Posterior capsule tear
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Reproductive system and breast disorders
Prostatic hyperplasia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Punctate Keratitis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.2%
4/343 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.7%
3/110 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.8%
2/110 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.0%
7/343 • Number of events 7 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
2.7%
3/110 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Restless legs syndrome
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Retinal Drusen
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Retinal Tear
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Retinal Vein Occlusion
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Endocrine disorders
Swollen lymph nodes/glands
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Thrombocytopenia
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Thrombosis/Thrombus
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Thrombus
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Vascular disorders
Transient ischemic attack
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Trichiasis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Unspecified infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Psychiatric disorders
Unspecified mental, emotional or behavioural problem
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Musculoskeletal and connective tissue disorders
Unspecified musculoskeletal problem
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Nervous system disorders
Unspecified nervous system problem
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
3.6%
4/110 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Renal and urinary disorders
Urolithiasis
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Uveitis (intermediate)
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Vertigo
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Infections and infestations
Viral infection
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Vision Blurred
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.58%
2/343 • Number of events 2 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.87%
3/343 • Number of events 3 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Visual Acuity Reduced
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
1.2%
4/343 • Number of events 4 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Eye disorders
Vitreoretinal Traction Syndrome
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
General disorders
Vomiting
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.29%
1/343 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
|
Injury, poisoning and procedural complications
Whiplash injury to neck
|
0.00%
0/453 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/343 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.00%
0/110 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
0.91%
1/110 • Number of events 1 • Second eye implantation through study completion; approximately 1-year (12 months).
Adverse Events (AE) were obtained through both solicited (non-directed questions) and spontaneous reports from subjects, as well as through observations by the Investigator during clinical examination. The Safety population (analysis population) includes all bilaterally implanted subjects as well as those subjects not successfully implanted with the IC-8™ IOL but for whom the IC-8™ IOL touched the eye. Ocular Adverse Events are based on a Modified Version of AAO Consensus (Masket et al., 2017).
|
Additional Information
Magda Michna, PhD., Chief Global Clinical, Medical and Regulatory Affairs Officer
AcuFocus, Inc.
Phone: (949) 585-9511
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the PI must provide sponsor a manuscript of such submission(s) for review, comment and approval at least 90 days prior to a planned submission for publication or presentation and that sponsor is permitted to delay any publication or presentation in specific circumstances.
- Publication restrictions are in place
Restriction type: OTHER