Trial Outcomes & Findings for Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] (NCT NCT01510717)

Last Updated: 2015-05-27

Results Overview

Visual acuity (VA) was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart set at 53 centimeters (cm) on the nearpoint rod. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.

Recruitment status

COMPLETED

Study phase

Target enrollment

409 participants

Primary outcome timeframe

Day 120-180 from second eye implantation

Results posted on

2015-05-27

Participant Flow

Participants were recruited and enrolled from 15 investigative sites located in the United States.

Of the 409 participants enrolled, 80 were discontinued prior to randomization as screen failures and 9 were discontinued after randomization prior to implantation. This reporting group includes all participants with successful IOL implantation in at least 1 eye (320).

Participant milestones

Participant milestones
Measure	Multifocal IOL AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL AcrySof® IQ Monofocal IOL Model SN60WF
Overall Study STARTED	155	165
Overall Study COMPLETED	153	160
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Multifocal IOL AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL AcrySof® IQ Monofocal IOL Model SN60WF
Overall Study Adverse Event	1	2
Overall Study Death	1	0
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Clinical Investigation of AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0]

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multifocal IOL n=155 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=165 Participants AcrySof® IQ Monofocal IOL Model SN60WF	Total n=320 Participants Total of all reporting groups
Age, Continuous	68.7 years STANDARD_DEVIATION 9.64 • n=5 Participants	69.4 years STANDARD_DEVIATION 8.27 • n=7 Participants	69.0 years STANDARD_DEVIATION 8.95 • n=5 Participants
Age, Customized 20-29 years	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Age, Customized 30-39 years	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Age, Customized 40-49 years	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Age, Customized 50-59 years	18 participants n=5 Participants	12 participants n=7 Participants	30 participants n=5 Participants
Age, Customized 60-69 years	53 participants n=5 Participants	62 participants n=7 Participants	115 participants n=5 Participants
Age, Customized 70-79 years	65 participants n=5 Participants	71 participants n=7 Participants	136 participants n=5 Participants
Age, Customized ≥80 years	14 participants n=5 Participants	17 participants n=7 Participants	31 participants n=5 Participants
Sex: Female, Male Female	96 Participants n=5 Participants	97 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	68 Participants n=7 Participants	127 Participants n=5 Participants
Region of Enrollment United States	155 participants n=5 Participants	165 participants n=7 Participants	320 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 120-180 from second eye implantation

Population: This analysis population includes all participants with successful IOL implantation in the primary eye.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=155 eyes AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=165 eyes AcrySof® IQ Monofocal IOL Model SN60WF
Mean Photopic Monocular Distance Corrected VA (53 cm) at Day 120-180	0.322 logMAR Standard Error 0.014	0.512 logMAR Standard Error 0.013

PRIMARY outcome

Timeframe: Day 0 first operative eye visit, up to Day 120-180 from second eye implantation

Population: This analysis population includes all participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye).

Cumulative and persistent adverse events were collected. This outcome measure was prespecified for the multifocal IOL.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=310 eyes AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL AcrySof® IQ Monofocal IOL Model SN60WF
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Cystoid macular oedema (cumulative)	4 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Endophthalmitis (cumulative)	0 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Hypopyon (cumulative)	0 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Lens dislocated from posterior (cumulative)	0 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Pupillary block (cumulative)	0 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Retinal detachment (cumulative)	0 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Secondary surgical intervention (cumulative)	0 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Corneal stroma oedema (persistent)	0 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Cystoid macular oedema (persistent	2 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Iritis (persistent	2 adverse events	—
Number of Cumulative and Persistent Adverse Events as Defined in IS EN ISO 11979-7:2006, up to Day 120-180 Raised IOP requiring treatment (persistent)	0 adverse events	—

PRIMARY outcome

Timeframe: Day 120-180 from second eye implantation

Population: The analysis population includes all participants with successful IOL implantation that had at least 1 postoperative visit, had no preoperative pathology or macular degeneration, and had no major protocol deviations at any time. Here n=number of participants with data for analysis.

Contrast sensitivity (ie, the ability to detect objects by distinguishing them from their background) was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=133 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=137 Participants AcrySof® IQ Monofocal IOL Model SN60WF
Photopic Contrast Sensitivity Without Glare at Day 120-180 3 cpd (n=131,133)	1.676 logMAR Standard Deviation 0.259	1.743 logMAR Standard Deviation 0.203
Photopic Contrast Sensitivity Without Glare at Day 120-180 6 cpd (n=130,133)	1.816 logMAR Standard Deviation 0.256	1.938 logMAR Standard Deviation 0.251
Photopic Contrast Sensitivity Without Glare at Day 120-180 12 cpd (n=129,132)	1.460 logMAR Standard Deviation 0.312	1.555 logMAR Standard Deviation 0.312
Photopic Contrast Sensitivity Without Glare at Day 120-180 18 cpd (n=130,131)	0.970 logMAR Standard Deviation 0.348	1.109 logMAR Standard Deviation 0.325

PRIMARY outcome

Timeframe: Day 120-180 from second eye implantation

Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under photopic (bright) conditions at a distance of 8 feet at spatial frequencies of 3, 6, 12, and 18 cycles per degree (cpd) using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=133 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=137 Participants AcrySof® IQ Monofocal IOL Model SN60WF
Photopic Contrast Sensitivity With Glare at Day 120-180 3 cpd (n=130,131)	1.608 logMAR Standard Deviation 0.307	1.692 logMAR Standard Deviation 0.274
Photopic Contrast Sensitivity With Glare at Day 120-180 6 cpd (n=117,125)	1.684 logMAR Standard Deviation 0.316	1.844 logMAR Standard Deviation 0.309
Photopic Contrast Sensitivity With Glare at Day 120-180 12 cpd (n=117,127)	1.334 logMAR Standard Deviation 0.321	1.475 logMAR Standard Deviation 0.336
Photopic Contrast Sensitivity With Glare at Day 120-180 18 cpd (n=119,128)	0.914 logMAR Standard Deviation 0.333	1.043 logMAR Standard Deviation 0.361

PRIMARY outcome

Timeframe: Day 120-180 from second eye implantation

Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic (dim lighting) conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cycles per degree (cpd) using the Vector Vision CSV 1000 without a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=133 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=137 Participants AcrySof® IQ Monofocal IOL Model SN60WF
Mesopic Contrast Sensitivity Without Glare at Day 120-180 1.5 cpd (n=128,131)	1.594 logMAR Standard Deviation 0.224	1.622 logMAR Standard Deviation 0.204
Mesopic Contrast Sensitivity Without Glare at Day 120-180 3 cpd (n=131,132)	1.563 logMAR Standard Deviation 0.267	1.618 logMAR Standard Deviation 0.226
Mesopic Contrast Sensitivity Without Glare at Day 120-180 6 cpd (n=122,130)	1.581 logMAR Standard Deviation 0.296	1.673 logMAR Standard Deviation 0.275
Mesopic Contrast Sensitivity Without Glare at Day 120-180 12 cpd (n=102,112)	1.077 logMAR Standard Deviation 0.363	1.208 logMAR Standard Deviation 0.345

PRIMARY outcome

Timeframe: Day 120-180 from second eye implantation

Contrast sensitivity was assessed binocularly with the participant's best spectacle correction under mesopic conditions at a distance of 8 feet at spatial frequencies of 1.5, 3, 6, and 12 cpd using the Vector Vision CSV 1000 with a glare source. Raw scores from contrast sensitivity testing were transformed to log units. Scores of (-1) were set to missing; hence, the mean measures may be overestimated and the variability measures may be underestimated. A higher numeric value represents better contrast sensitivity.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=133 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=137 Participants AcrySof® IQ Monofocal IOL Model SN60WF
Mesopic Contrast Sensitivity With Glare at Day 120-180 12 cpd (n=90,105)	1.043 logMAR Standard Deviation 0.385	1.153 logMAR Standard Deviation 0.375
Mesopic Contrast Sensitivity With Glare at Day 120-180 1.5 cpd (n=127,129)	1.536 logMAR Standard Deviation 0.237	1.596 logMAR Standard Deviation 0.238
Mesopic Contrast Sensitivity With Glare at Day 120-180 3 cpd (n=128,130)	1.542 logMAR Standard Deviation 0.292	1.600 logMAR Standard Deviation 0.296
Mesopic Contrast Sensitivity With Glare at Day 120-180 6 cpd (n=114,126)	1.543 logMAR Standard Deviation 0.329	1.617 logMAR Standard Deviation 0.277

SECONDARY outcome

Timeframe: Day 120-180 from second eye implantation

Population: This analysis population includes all participants with successful IOL implantation in the primary eye.

VA was tested monocularly (each eye separately) using the correction obtained from the manifest refraction and 100% contrast, ETDRS charts at a distance of 4 meters. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=155 eyes AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=165 eyes AcrySof® IQ Monofocal IOL Model SN60WF
Mean Photopic Monocular Best Corrected Distance VA (4 m) at Day 120-180	0.025 logMAR Standard Error 0.009	0.003 logMAR Standard Error 0.009

SECONDARY outcome

Timeframe: Day 120-180 from second eye implantation

Population: This analysis population includes all participants with successful IOL implantation in the primary eye.

VA was tested monocularly (each eye separately) using the manifest refraction adjusted for optical infinity and the hand-held, 100% contrast, ETDRS chart set at 40 cm on the nearpoint rod. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the primary eye.

Outcome measures

Outcome measures
Measure	Multifocal IOL n=155 eyes AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=165 eyes AcrySof® IQ Monofocal IOL Model SN60WF
Mean Photopic Monocular Distance Corrected Near VA at Standard Distance (40 cm) at Day 120-180	0.426 logMAR Standard Error 0.014	0.632 logMAR Standard Error 0.013

SECONDARY outcome

Timeframe: Day 120-180 from second eye implantation

Population: This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.

Overall Spectacle Independence was rated using SILVER (Spectacle Independence Lens Vision Evaluation and Repurchase), a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses overall?"

Outcome measures

Outcome measures
Measure	Multifocal IOL n=153 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=160 Participants AcrySof® IQ Monofocal IOL Model SN60WF
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 None of the time	35 participants	33 participants
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 Some of the time	104 participants	109 participants
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 Most of the time	12 participants	13 participants
Overall Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 All of the time	2 participants	5 participants

SECONDARY outcome

Timeframe: Day 120-180 from second eye implantation

Population: This analysis population includes all participants with successful IOL implantation in at least 1 eye with data present.

Near Spectacle Independence was rated using SILVER, a new patient reported outcome questionnaire. The participant was asked, "How often do you wear eyeglasses or contact lenses for seeing objects up close?"

Outcome measures

Outcome measures
Measure	Multifocal IOL n=153 Participants AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=160 Participants AcrySof® IQ Monofocal IOL Model SN60WF
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 None of the time	25 participants	19 participants
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 Some of the time	70 participants	53 participants
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 Most of the time	34 participants	40 participants
Near Spectacle Independence Using SILVER Patient Reported Outcome (PRO) Questionnaire at Day 120-180 All of the time	24 participants	48 participants

Adverse Events

Pre-Treatment

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Multifocal IOL

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Monofocal IOL

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Magda Michna, PhD

Alcon Research, Ltd.

Phone: 1-888-451-3937

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER

Serious adverse events
Measure	Pre-Treatment n=409 participants at risk All enrolled participants	Multifocal IOL n=155 participants at risk All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 \[SV25T0\]	Monofocal IOL n=165 participants at risk All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ Monofocal IOL Model SN60WF
Eye disorders Cystoid macular oedema (First Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	1.3% 2/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Investigations Intraocular pressure increased (First Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Open angle glaucoma (First Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Injury, poisoning and procedural complications Cataract operation complication (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Cystoid macular oedema (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	1.3% 2/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
General disorders Device dislocation (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Surgical and medical procedures Eye operation (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Surgical and medical procedures Intraocular injection (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Investigations Intraocular pressure increased (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Iritis (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Open angle glaucoma (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Eye disorders Retinal vein occlusion (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Injury, poisoning and procedural complications Surgical procedure repeated (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Injury, poisoning and procedural complications Wound complication (Second Implanted Eye)	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/163 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Gastrointestinal disorders Abdominal mass	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Blood and lymphatic system disorders Anaemia	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Vascular disorders Aortic stenosis	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Cardiac disorders Atrial fibrillation	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Infections and infestations Cellulitis	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Nervous system disorders Cerebrovascular accident	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	1.3% 2/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Nervous system disorders Convulsion	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Skin and subcutaneous tissue disorders Dry gangrene	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Infections and infestations Extradural abscess	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Infections and infestations Incisional hernia gangrenous	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Injury, poisoning and procedural complications Injury	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's lymphoma	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Gastrointestinal disorders Pancreatitis	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Infections and infestations Pneumonia	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Renal and urinary disorders Renal failure acute	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer stage unspecified	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Renal and urinary disorders Urinary retention	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Infections and infestations Urinary tract infection	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.65% 1/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Nervous system disorders Syncope	0.24% 1/409 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.00% 0/155 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."	0.61% 1/165 • Adverse events (AEs) were collected for the duration of the study (Feb 2012-Dec 2012). An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."