Trial Outcomes & Findings for Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL) (NCT NCT04098367)

Last Updated: 2022-05-04

Results Overview

QUVID is a patient-reported outcomes questionnaire that collects responses from the subject about vision-related experiences. A halo is a circular spreading of light around a light source, such as car headlights at night. Question 2 of QUVID asked the subject, "In the past 7 days, have you experienced halos?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 2.3: "In the past 7 days, how much have your halos bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.

Recruitment status

COMPLETED

Study phase

Target enrollment

222 participants

Primary outcome timeframe

Month 3 postoperative (Day 120-180 from second eye surgery)

Results posted on

2022-05-04

Participant Flow

Participants were recruited from nine investigative sites located in Australia and three investigative sites located in New Zealand.

Of the 222 enrolled, 24 subjects were exited as screen failures prior to randomization. Of the 198 subjects randomized, both eyes from five subjects and second eyes from 2 subjects (i.e., 5 first eyes, 7 second eyes) were discontinued after randomization and prior to attempted implantation. This reporting group includes all randomized and implanted subjects (193).

Participant milestones

Participant milestones
Measure	VIVITY VIVITY IOL implanted in the eye during cataract surgery	SYMFONY SYMFONY IOL implanted in the eye during cataract surgery	AT LARA AT LARA implanted in the eye during cataract surgery
Overall Study STARTED	63	65	65
Overall Study First Eye Implanted	63	65	65
Overall Study Second Eye Implanted	63	65	63
Overall Study COMPLETED	61	60	61
Overall Study NOT COMPLETED	2	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	VIVITY VIVITY IOL implanted in the eye during cataract surgery	SYMFONY SYMFONY IOL implanted in the eye during cataract surgery	AT LARA AT LARA implanted in the eye during cataract surgery
Overall Study Adverse Event	0	0	1
Overall Study Lost to Follow-up	1	5	2
Overall Study Withdrawal by Subject	0	0	1
Overall Study Sick . Could not attend visit	1	0	0

Baseline Characteristics

Clinical Investigation of the AcrySof IQ Vivity Extended Vision Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	VIVITY n=63 Participants VIVITY IOL implanted in the eye during cataract surgery	SYMFONY n=65 Participants SYMFONY IOL implanted in the eye during cataract surgery	AT LARA n=65 Participants AT LARA implanted in the eye during cataract surgery	Total n=193 Participants Total of all reporting groups
Age, Continuous	67.2 years STANDARD_DEVIATION 8.07 • n=5 Participants	67.0 years STANDARD_DEVIATION 9.25 • n=7 Participants	66.1 years STANDARD_DEVIATION 8.60 • n=5 Participants	66.7 years STANDARD_DEVIATION 8.63 • n=4 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	36 Participants n=7 Participants	40 Participants n=5 Participants	114 Participants n=4 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	29 Participants n=7 Participants	25 Participants n=5 Participants	79 Participants n=4 Participants
Race/Ethnicity, Customized White (Caucasian)	58 Participants n=5 Participants	47 Participants n=7 Participants	54 Participants n=5 Participants	159 Participants n=4 Participants
Race/Ethnicity, Customized Black	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Indigenous or Other Pacific Islander	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	15 Participants n=4 Participants
Race/Ethnicity, Customized Other	2 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	13 Participants n=4 Participants

PRIMARY outcome

Timeframe: Month 3 postoperative (Day 120-180 from second eye surgery)

Population: AAS with data at Month 3 postoperative visit

Outcome measures

Outcome measures
Measure	VIVITY n=63 Participants VIVITY IOL implanted in the eye during cataract surgery	SYMFONY n=65 Participants SYMFONY IOL implanted in the eye during cataract surgery	AT LARA n=63 Participants AT LARA implanted in the eye during cataract surgery
Percentage of Subjects Not Bothered at All by Halos (QUVID Question 2.3)	88.7 percentage of subjects	58.1 percentage of subjects	58.6 percentage of subjects

SECONDARY outcome

Timeframe: Month 3 postoperative (Day 120-180 from second eye surgery)

Population: AAS with data at Month 3 postoperative visit

Glare is a wide dispersion of light, such as an intensified reflection of the sun off a glass building. Question 3 of QUVID asked the subject, "In the past 7 days, have you experienced glare?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 3.3: "In the past 7 days, how much has your glare bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.

Outcome measures

Outcome measures
Measure	VIVITY n=62 Participants VIVITY IOL implanted in the eye during cataract surgery	SYMFONY n=63 Participants SYMFONY IOL implanted in the eye during cataract surgery	AT LARA n=60 Participants AT LARA implanted in the eye during cataract surgery
Percentage of Subjects Not Bothered at All by Glare (QUVID Question 3.3)	53.2 percentage of subjects	55.6 percentage of subjects	35.0 percentage of subjects

SECONDARY outcome

Timeframe: Month 3 postoperative (Day 120-180 from second eye surgery)

Population: AAS with data at Month 3 postoperative visit

A starburst is a star-shaped spreading of light around a light source, such as car headlights at night. Question 1 of QUVID asked the subject, "In the past 7 days, have you experienced starbursts?" Subjects responding "No" were automatically imputed as reporting, "0=Not bothered at all." Subjects responding "Yes" were then asked Question 1.3: "In the past 7 days, how much have your starbursts bothered you?" Subjects responded on a 5-point scale: 0=Not bothered at all; 1=Bothered a little bit; 2=Bothered somewhat; 3=Bothered quite a bit; 4=Bothered very much. Percentage was calculated as number of subjects with score of 0 divided by number of subjects with data regardless of response, times 100.

Outcome measures

Outcome measures
Measure	VIVITY n=62 Participants VIVITY IOL implanted in the eye during cataract surgery	SYMFONY n=63 Participants SYMFONY IOL implanted in the eye during cataract surgery	AT LARA n=60 Participants AT LARA implanted in the eye during cataract surgery
Percentage of Subjects Not Bothered at All by Starbursts (QUVID Question 1.3)	79.0 percentage of subjects	55.6 percentage of subjects	38.3 percentage of subjects

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pretreatment n=193 participants at risk All subjects prior to with attempted implantation with any IOL (successful or aborted implant)	VIVITY First Eye n=63 participants at risk All eyes that had contact with the VIVITY IOL (successful or aborted implant)	VIVITY Second Eye n=63 participants at risk All eyes that had contact with the VIVITY IOL (successful or aborted implant)	VIVITY Systemic n=63 participants at risk All subjects that had contact with the VIVITY IOL (successful or aborted implant)	SYMFONY First Eye n=65 participants at risk All eyes that had contact with the SYMFONY IOL (successful or aborted implant)	SYMFONY Second Eye n=65 participants at risk All eyes that had contact with the SYMFONY IOL (successful or aborted implant)	SYMFONY Systemic n=65 participants at risk All subjects that had contact with the SYMFONY IOL (successful or aborted implant)	AT LARA First Eye n=65 participants at risk All eyes that had contact with the AT LARA IOL (successful or aborted implant)	AT LARA Second Eye n=63 participants at risk All eyes that had contact with the AT LARA IOL (successful or aborted implant)	AT LARA Systemic n=65 participants at risk All subjects that had contact with the AT LARA IOL (successful or aborted implant)
Cardiac disorders Atrial fibrillation	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Cardiac disorders Coronary artery disease	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	3.1% 2/65 • Number of events 2 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.6% 1/63 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Halo vision	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Macular fibrosis	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.6% 1/63 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Visual impairment	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Fall	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Posterior capsule rupture	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Investigations Intraocular pressure increased	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.
Investigations Paracentesis	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.6% 1/63 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Carotid artery aneurysm	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Angioplasty	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Lens extraction	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Parathyroidectomy	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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 Retinal operation	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.6% 1/63 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	1.5% 1/65 • Number of events 1 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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

Other adverse events
Measure	Pretreatment n=193 participants at risk All subjects prior to with attempted implantation with any IOL (successful or aborted implant)	VIVITY First Eye n=63 participants at risk All eyes that had contact with the VIVITY IOL (successful or aborted implant)	VIVITY Second Eye n=63 participants at risk All eyes that had contact with the VIVITY IOL (successful or aborted implant)	VIVITY Systemic n=63 participants at risk All subjects that had contact with the VIVITY IOL (successful or aborted implant)	SYMFONY First Eye n=65 participants at risk All eyes that had contact with the SYMFONY IOL (successful or aborted implant)	SYMFONY Second Eye n=65 participants at risk All eyes that had contact with the SYMFONY IOL (successful or aborted implant)	SYMFONY Systemic n=65 participants at risk All subjects that had contact with the SYMFONY IOL (successful or aborted implant)	AT LARA First Eye n=65 participants at risk All eyes that had contact with the AT LARA IOL (successful or aborted implant)	AT LARA Second Eye n=63 participants at risk All eyes that had contact with the AT LARA IOL (successful or aborted implant)	AT LARA Systemic n=65 participants at risk All subjects that had contact with the AT LARA IOL (successful or aborted implant)
Eye disorders Posterior capsule opacification	0.00% 0/193 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	11.1% 7/63 • Number of events 7 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	11.1% 7/63 • Number of events 7 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/63 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	18.5% 12/65 • Number of events 12 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	15.4% 10/65 • Number of events 10 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	26.2% 17/65 • Number of events 19 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.	25.4% 16/63 • Number of events 17 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. 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% 0/65 • Pre-operation (Day -28) up to Day 120-180 (post second eye implantation), 6-7 months. An AE was defined at 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 test article. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator. At Risk" population of preoperative and systemic AEs is reported in units of subjects; all other AE populations are reported in units of eyes.

Additional Information

Sr. CDMA Project Lead, Surgical

Alcon Research, LLC

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.
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