Trial Outcomes & Findings for Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL) (NCT NCT06166901)
NCT ID: NCT06166901
Last Updated: 2026-03-23
Results Overview
Device deficiencies were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of device deficiencies include the following: * Failure to meet product specifications (e.g., incorrect IOL power) * IOL defect * Broken IOL optic * Broken IOL haptic * Scratched IOL optic * Unsealed device packaging * Suspected product contamination * Lack of performance This outcome measure was pre-specified for eye-based reporting.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
211 participants
Primary outcome timeframe
Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)
Results posted on
2026-03-23
Participant Flow
Subjects were recruited from 7 investigative sites located in Spain.
Of the 211 enrolled, 3 subjects were exited as screen failures. This reporting group includes all enrolled subjects who passed screening (Full Analysis Set). Note: 34 subjects were implanted with toric in one eye and non-toric in the other eye.
Unit of analysis: eyes
Participant milestones
| Measure |
AcrySof IQ PanOptix Toric
AcrySof IQ PanOptix IOL Toric in both eyes
|
AcrySof IQ PanOptix Non-Toric
AcrySof IQ PanOptix IOL Non-Toric in both eyes
|
|---|---|---|
|
Overall Study
STARTED
|
103 172
|
139 244
|
|
Overall Study
Both Eyes Implanted
|
69 138
|
105 210
|
|
Overall Study
One Eye Implanted
|
34 34
|
34 34
|
|
Overall Study
COMPLETED
|
103 172
|
139 244
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Long-term Safety and Performance of PanOptix Trifocal Intraocular Lens (IOL)
Baseline characteristics by cohort
| Measure |
Total
n=208 Participants
Total of all reporting groups
|
AcrySof IQ PanOptix IOL Toric
n=103 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL (Toric or Non Toric) in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with AcrySof IQ PanOptix IOL Toric
|
AcrySof IQ PanOptix IOL Non Toric
n=105 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL Non Toric in both eyes 3-5 years prior to enrollment
|
|---|---|---|---|
|
Age, Customized
Less than 65 years
|
73 Participants
n=18 Participants
|
35 Participants
n=10 Participants
|
38 Participants
n=8 Participants
|
|
Age, Customized
Equal to or greater than 65 years
|
135 Participants
n=18 Participants
|
68 Participants
n=10 Participants
|
67 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=18 Participants
|
64 Participants
n=10 Participants
|
68 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=18 Participants
|
39 Participants
n=10 Participants
|
37 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
125 Participants
n=18 Participants
|
58 Participants
n=10 Participants
|
67 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
83 Participants
n=18 Participants
|
45 Participants
n=10 Participants
|
38 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=18 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=18 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
207 Participants
n=18 Participants
|
103 Participants
n=10 Participants
|
104 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=18 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
Spain
|
208 participants
n=18 Participants
|
103 participants
n=10 Participants
|
105 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Year 3-5 postoperative (Visit 1, Day 1)Population: Full Analysis Set
BCDVA was assessed for both eyes together at a distance of 4 meters using letter charts and recorded in logarithm of the minimum angle of resolution (logMAR). The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. Subjects with at least one implanted eye with a toric IOL were categorized as toric as specified in the statistical analysis plan. No hypothesis testing was pre-specified for this endpoint.
Outcome measures
| Measure |
AcrySof IQ PanOptix IOL Toric
n=103 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL (Toric or Non-Toric) in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with AcrySof IQ PanOptix Toric IOL
|
AcrySof IQ PanOptix IOL Non-Toric
n=105 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment
|
|---|---|---|
|
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA)
|
-0.019 LogMAR
Standard Deviation 0.0815
|
-0.012 LogMAR
Standard Deviation 0.0660
|
PRIMARY outcome
Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)Population: All enrolled eyes that passed screening.
Ocular adverse events were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of ocular adverse events include the following: * Cystoid Macular Edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary block * Retinal detachment * Secondary Surgical Interventions (explantation/exchange/repositioning) This outcome measure was pre-specified for eye-based reporting.
Outcome measures
| Measure |
AcrySof IQ PanOptix IOL Toric
n=172 eyes
Subjects that were implanted with AcrySof IQ PanOptix IOL (Toric or Non-Toric) in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with AcrySof IQ PanOptix Toric IOL
|
AcrySof IQ PanOptix IOL Non-Toric
n=244 eyes
Subjects that were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment
|
|---|---|---|
|
Number of Eyes Experiencing an Ocular Adverse Event by Toricity
|
108 eye
|
120 eye
|
PRIMARY outcome
Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)Population: All enrolled subjects that passed screening. Subjects with at least one implanted eye with a toric IOL were categorized as toric as specified in the statistical analysis plan.
AEs were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative).
Outcome measures
| Measure |
AcrySof IQ PanOptix IOL Toric
n=103 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL (Toric or Non-Toric) in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with AcrySof IQ PanOptix Toric IOL
|
AcrySof IQ PanOptix IOL Non-Toric
n=105 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment
|
|---|---|---|
|
Number of Subjects Experiencing a Non-Ocular Adverse Event
|
14 subject
|
6 subject
|
PRIMARY outcome
Timeframe: Retrospective data from preoperative visit to Year 3-5 postoperative (Visit 1, Day 1)Population: All enrolled eyes that passed screening.
Device deficiencies were identified retrospectively from chart review of operative and immediate postoperative activities and prospectively at Visit 1 (Year 3-5 postoperative). Examples of device deficiencies include the following: * Failure to meet product specifications (e.g., incorrect IOL power) * IOL defect * Broken IOL optic * Broken IOL haptic * Scratched IOL optic * Unsealed device packaging * Suspected product contamination * Lack of performance This outcome measure was pre-specified for eye-based reporting.
Outcome measures
| Measure |
AcrySof IQ PanOptix IOL Toric
n=103 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL (Toric or Non-Toric) in both eyes 3-5 years prior to enrollment, with at least one of the eyes implanted with AcrySof IQ PanOptix Toric IOL
|
AcrySof IQ PanOptix IOL Non-Toric
n=139 Participants
Subjects that were implanted with AcrySof IQ PanOptix IOL Non-Toric in both eyes 3-5 years prior to enrollment
|
|---|---|---|
|
Number of Device Deficiencies by Toricity
|
2 device deficiencies
|
8 device deficiencies
|
Adverse Events
AcrySof IQ PanOptix IOL Toric First Implanted Eye
Serious events: 0 serious events
Other events: 42 other events
Deaths: 0 deaths
AcrySof IQ PanOptix IOL Toric Second Implanted Eye
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
AcrySof IQ PanOptix IOL Toric Systemic
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
AcrySof IQ PanOptix IOL Non-Toric First Implanted Eye
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
AcrySof IQ PanOptix IOL Non-Toric Second Implanted Eye
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
AcrySof IQ PanOptix IOL Non-Toric Systemic
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AcrySof IQ PanOptix IOL Toric First Implanted Eye
n=90 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Toric
|
AcrySof IQ PanOptix IOL Toric Second Implanted Eye
n=82 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Toric
|
AcrySof IQ PanOptix IOL Toric Systemic
n=103 participants at risk
Subject implanted with AcrySof IQ PanOptix IOL (Toric or Non Toric) with at least one of the eyes implanted with AcrySof IQ PanOptix Toric IOL
|
AcrySof IQ PanOptix IOL Non-Toric First Implanted Eye
n=118 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Non Toric
|
AcrySof IQ PanOptix IOL Non-Toric Second Implanted Eye
n=126 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Non Toric
|
AcrySof IQ PanOptix IOL Non-Toric Systemic
n=105 participants at risk
Subject implanted with AcrySof IQ PanOptix IOL Non Toric in both eyes
|
|---|---|---|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
1.2%
1/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.00%
0/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.00%
0/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Eye disorders
Retinal oedema
|
0.00%
0/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
1.2%
1/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.85%
1/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.00%
0/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast neoplasm
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.97%
1/103 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.95%
1/105 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.00%
0/103 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.95%
1/105 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Eye disorders
Cystoid macular oedema
|
0.00%
0/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.00%
0/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
0.00%
0/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
1.6%
2/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
Other adverse events
| Measure |
AcrySof IQ PanOptix IOL Toric First Implanted Eye
n=90 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Toric
|
AcrySof IQ PanOptix IOL Toric Second Implanted Eye
n=82 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Toric
|
AcrySof IQ PanOptix IOL Toric Systemic
n=103 participants at risk
Subject implanted with AcrySof IQ PanOptix IOL (Toric or Non Toric) with at least one of the eyes implanted with AcrySof IQ PanOptix Toric IOL
|
AcrySof IQ PanOptix IOL Non-Toric First Implanted Eye
n=118 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Non Toric
|
AcrySof IQ PanOptix IOL Non-Toric Second Implanted Eye
n=126 participants at risk
Eye implanted with AcrySof IQ PanOptix IOL Non Toric
|
AcrySof IQ PanOptix IOL Non-Toric Systemic
n=105 participants at risk
Subject implanted with AcrySof IQ PanOptix IOL Non Toric in both eyes
|
|---|---|---|---|---|---|---|
|
Eye disorders
Blepharitis
|
10.0%
9/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
13.4%
11/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
11.0%
13/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
10.3%
13/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Product Issues
Device material issue
|
3.3%
3/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
2.4%
2/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
9.3%
11/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
7.9%
10/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Eye disorders
Dry eye
|
11.1%
10/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
17.1%
14/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
12.7%
15/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
9.5%
12/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Eye disorders
Posterior capsule opacification
|
27.8%
25/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
40.2%
33/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
26.3%
31/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
24.6%
31/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
|
Eye disorders
Vitreous detachment
|
15.6%
14/90 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
15.9%
13/82 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
9.3%
11/118 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
7.1%
9/126 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
|
—
0/0 • AEs were collected from preoperative visit through Day 1 enrollment, up to 5 years. All subjects were monitored for serious and other ocular and nonocular AEs. However, the nonocular AE arms were not considered at risk for ocular adverse event terms as the arms are reporting nonocular-specific AEs. Similarly, the ocular AE arms were not considered at risk for nonocular adverse event terms as the arms are reporting ocular-specific AEs. All-Cause Mortality was not monitored for the ocular arms.
An 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. AEs were identified retrospectively during chart review and prospectively at Visit 1 (Year 3-5 postoperative). "At Risk" population for ocular AEs is reported in units of eyes; all other populations are reported in units of subjects.
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Additional Information
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