Trial Outcomes & Findings for A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL) (NCT NCT03010254)

Last Updated: 2020-04-07

Results Overview

Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

Recruitment status

COMPLETED

Study phase

Target enrollment

322 participants

Primary outcome timeframe

Month 3 (70-100 days post second eye implantation)

Results posted on

2020-04-07

Participant Flow

Subjects were recruited from 21 investigative sites located in Australia, Canada, Spain and the United Kingdom.

A total of 322 subjects were enrolled in the study, out of which 39 subjects exited due to screen failure and 1 subject discontinued due to site being closed before actual screening visit and randomization. This reporting group includes all randomized subjects.

Participant milestones

Participant milestones
Measure	DFT015 ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation	SN60WF ACRYSOF® IQ Monofocal IOL, bilateral implantation
Overall Study STARTED	159	123
Overall Study Attempted Implantation	156	120
Overall Study Successful Implantation	156	120
Overall Study COMPLETED	152	118
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Reasons for withdrawal
Measure	DFT015 ACRYSOF® IQ Extended Depth of Focus Intraocular lens (IOL), bilateral implantation	SN60WF ACRYSOF® IQ Monofocal IOL, bilateral implantation
Overall Study Adverse Event	0	1
Overall Study Lost to Follow-up	4	0
Overall Study Withdrawal by Subject	1	1
Overall Study Other	2	3

Baseline Characteristics

A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DFT015 n=156 Participants ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=120 Participants ACRYSOF® IQ Monofocal IOL, bilateral implantation	Total n=276 Participants Total of all reporting groups
Age, Continuous	69.7 years STANDARD_DEVIATION 7.37 • n=99 Participants	69.7 years STANDARD_DEVIATION 7.54 • n=107 Participants	69.7 years STANDARD_DEVIATION 7.43 • n=206 Participants
Sex: Female, Male Female	94 Participants n=99 Participants	65 Participants n=107 Participants	159 Participants n=206 Participants
Sex: Female, Male Male	62 Participants n=99 Participants	55 Participants n=107 Participants	117 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	31 Participants n=99 Participants	25 Participants n=107 Participants	56 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	107 Participants n=99 Participants	79 Participants n=107 Participants	186 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	18 Participants n=99 Participants	16 Participants n=107 Participants	34 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	12 Participants n=99 Participants	8 Participants n=107 Participants	20 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	4 Participants n=99 Participants	1 Participants n=107 Participants	5 Participants n=206 Participants
Race (NIH/OMB) White	129 Participants n=99 Participants	101 Participants n=107 Participants	230 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants

PRIMARY outcome

Timeframe: Month 3 (70-100 days post second eye implantation)

Population: All-Implanted Analysis Set

Outcome measures

Outcome measures
Measure	DFT015 n=153 Eyes ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=115 Eyes ACRYSOF® IQ Monofocal IOL, bilateral implantation
Monocular Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeters (cm)	0.175 logMAR Standard Error 0.0137	0.313 logMAR Standard Error 0.0158

PRIMARY outcome

Timeframe: Day 0 (first operative eye visit) up to Month 6 (120-180 days post second eye implantation)

Population: This analysis population included all eyes with attempted IOL implantation (successful or aborted after contact with the eye) (Safety Analysis Set). This outcome measure was pre-specified for the ACRYSOF® IQ Extended Depth of Focus IOL DTF015 only.

An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational medical device (test article). Ocular AEs are events localized to the eye. Cumulative and persistent serious adverse events as defined by ISO 11979-7:2014 were collected for Model DFT015 first and second eyes. No formal statistical hypothesis testing was planned.

Outcome measures

Outcome measures
Measure	DFT015 n=156 Eyes ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=154 Eyes ACRYSOF® IQ Monofocal IOL, bilateral implantation
Percentage of Subjects With Ocular Adverse Events Cumulative: Hypopyon	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Cumulative: Lens dislocated from posterior chamber	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Cumulative: Retinal detachment	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Persistent: Corneal stroma oedema	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Persistent: Iritis	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Persistent: Raised IOP requiring treatment	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Cumulative: Cystoid macular oedema	0.6 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Cumulative: Endophthalmitis	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Cumulative: Pupillary block	0.0 percentage of subjects	0.0 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Cumulative: Secondary surgical intervention	0.6 percentage of subjects	0.6 percentage of subjects
Percentage of Subjects With Ocular Adverse Events Persistent: Cystoid macular oedema	0.0 percentage of subjects	0.0 percentage of subjects

SECONDARY outcome

Timeframe: Month 3 (70-100 days post second eye implantation)

Population: All-Implanted Analysis Set

VA was tested monocularly under photopic conditions using the correction obtained from the manual manifest refraction and 100% contrast, ETDRS charts at a distance of 4 m from the spectacle plane. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

Outcome measures

Outcome measures
Measure	DFT015 n=153 Eyes ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=115 Eyes ACRYSOF® IQ Monofocal IOL, bilateral implantation
Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters (m)	-0.007 logMAR Standard Error 0.0076	-0.044 logMAR Standard Error 0.0087

SECONDARY outcome

Timeframe: Month 3 (70-100 days post second eye implantation)

Population: All-Implanted Analysis Set

VA was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represented better VA. This analysis was prespecified for the first operative eye.

Outcome measures

Outcome measures
Measure	DFT015 n=153 Eyes ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=115 Eyes ACRYSOF® IQ Monofocal IOL, bilateral implantation
Monocular Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm	0.420 logMAR Standard Error 0.0142	0.510 logMAR Standard Error 0.0163

SECONDARY outcome

Timeframe: Month 3 (70-100 days post second eye implantation)

Population: This analysis population included all eyes successfully implanted that had at least 1 postoperative visit, no macular degeneration at any time, and no major protocol violations (Best-case Analysis Set). Number analyzed is the number of subjects/eyes with data available for analysis at specified defocus.

Depth of focus was assessed at 4 meters under photopic (well-lit) conditions using best corrected distance refraction, added defocus and 100% contrast ETDRS charts. VA was measured between +1.50 Diopter (D) and -2.50 D in 0.5 D defocus steps, except in the region from +0.50 D through -0.50 D, which was assessed in 0.25 D steps. VA was measured in logMAR, with 0.02 logMAR increment corresponding to a single letter or 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. The depth of focus was estimated as the dioptric 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. A lower numeric value represents better VA. This analysis was pre-specified for the first operative eye. No formal statistical hypothesis testing was planned.

Outcome measures

Outcome measures
Measure	DFT015 n=151 Eyes ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=104 Eyes ACRYSOF® IQ Monofocal IOL, bilateral implantation
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve	1.61 diopter	1.09 diopter

SECONDARY outcome

Timeframe: Month 6 (120-180 days post second eye implantation)

Population: All-Implanted Analysis Set. Number analyzed is the number of subjects/eyes with data available for analysis at without glare and with glare assessments.

Contrast sensitivity (i.e., the ability to detect objects by distinguishing them from their background) was assessed monocularly with the subject's best spectacle correction under mesopic (low, but not quite dark) conditions at a distance of 8 feet (2.45 m) from the eye at a spatial frequency of 12 cpd using the Vector Vision CSV 1000-HGT with and without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. A higher numeric value represented better contrast sensitivity. This analysis was prespecified for the first operative eye.

Outcome measures

Outcome measures
Measure	DFT015 n=156 Eyes ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=120 Eyes ACRYSOF® IQ Monofocal IOL, bilateral implantation
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) Without Glare	0.799 log unit Standard Error 0.0364	0.978 log unit Standard Error 0.0413
Monocular Mesopic Contrast Sensitivity at 12 Cycles Per Degree (Cpd) With Glare	0.794 log unit Standard Error 0.0357	0.975 log unit Standard Error 0.0406

SECONDARY outcome

Timeframe: Month 6 (120-180 days post second eye implantation)

Population: All-Implanted Analysis Set

Proportion of subjects was reported as a percentage. No formal statistical hypothesis testing was planned.

Outcome measures

Outcome measures
Measure	DFT015 n=106 Participants ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=80 Participants ACRYSOF® IQ Monofocal IOL, bilateral implantation
Percentage of Subjects Who Respond "Never" to Question 1 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Any Purpose?"	30.2 percentage of subjects	10.0 percentage of subjects

SECONDARY outcome

Timeframe: Month 6 (120-180 days post second eye implantation)

Population: All-Implanted Analysis Set

No formal statistical hypothesis testing was planned.

Outcome measures

Outcome measures
Measure	DFT015 n=106 Participants ACRYSOF® IQ Extended Depth of Focus IOL, bilateral implantation	SN60WF n=80 Participants ACRYSOF® IQ Monofocal IOL, bilateral implantation
Percentage of Subjects Who Respond "Never" to Question 3 of the Spectacle Use Questionnaire: "How Often Do You Wear Eyeglasses for Intermediate Tasks (e.g., Computer)?"	75.5 percentage of subjects	53.8 percentage of subjects

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Preoperative n=276 participants at risk All subjects in the safety analysis set prior to initiation of treatment	DFT015 First Eye n=156 participants at risk All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the first implanted eye	DFT015 Second Eye n=154 participants at risk All eyes with attempted test article implantation (successful or aborted after contact with the eye) in the second implanted eye	DFT015 Systemic n=156 participants at risk All subjects with attempted test article implantation (successful or aborted after contact with the eye)	SN60WF First Eye n=120 participants at risk All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the first implanted eye	SN60WF Second Eye n=119 participants at risk All eyes with attempted control article implantation (successful or aborted after contact with the eye) in the second implanted eye	SN60WF Systemic n=120 participants at risk All subjects with attempted control article implantation (successful or aborted after contact with the eye)
Cardiac disorders Acute myocardial infarction	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Cystoid macular oedema	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.64% 1/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Posterior capsule rupture	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.65% 1/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Refraction disorder	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.65% 1/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Eye disorders Vitreous loss	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.65% 1/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Gastrointestinal disorders Ileus	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.64% 1/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Gastrointestinal disorders Pancreatitis	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Hepatobiliary disorders Cholelithiasis	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.64% 1/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Infections and infestations Cholecystitis infective	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Infections and infestations Influenza	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.64% 1/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Infections and infestations Pneumonia	0.36% 1/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Nervous system disorders Cerebral infarction	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Nervous system disorders Syncope	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Product Issues Device dislocation	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.64% 1/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Hip arthroplasty	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Intraocular lens repositioning	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.64% 1/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Keratomileusis	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.65% 1/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Surgical and medical procedures Vitrectomy	0.00% 0/276 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.65% 1/154 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/156 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.83% 1/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/119 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	0.00% 0/120 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), up to 8 months An AE was any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. Safety Analysis Set. "At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.

Other adverse events

Adverse event data not reported

Additional Information

CDMA Project Lead

Alcon Research

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER