Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Phase: NA
Conditions: Aphakia, Presbyopia, Astigmatism
Sponsor: Alcon Research

 
 
 
Post Approval Study of the AcrySof® IQ ReSTOR®  
Toric IOLs 
 
STUDY ID 
ILR431b‐P001 
 
PROTOCOL v10 
September 2, 2020 
 
NCT03733730 
 

Document ID: 
V-CLN-0001270 
Status: Approved, Version: 10.0 
Approved Date: 02 Sep 2020 
Page 1 of 172 
 
Alcon – Business Use Only 
 
Clinical Trial Protocol 
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs  
 
Protocol Number:  
ILR431b-P001 
Sponsor Name & Address: 
Alcon Research, LLC and its affiliates (“Alcon”) 
6201 South Freeway 
Fort Worth, Texas  76134-2099 
Project Name / Number: 
AcrySof IQ ReSTOR Toric 3.0 D add (T3-T6)/255985 
Test Article(s) / Product(s): 
AcrySof® IQ ReSTOR® Toric IOLs  (AcrySof IQ 
RESTOR +3.0 D Multifocal Toric IOL, Models 
SND1T3, SND1T4, SND1T5, SND1T6 and AcrySof IQ 
RESTOR +2.5 D Multifocal Toric IOLs, Models 
SV25T3, SV25T4, SV25T5, and SV25T6), and AcrySof 
IQ ReSTOR +2.5 D Multifocal IOL, Model SV25T0 
Investigator Agreement: 
I have read the clinical study described herein, recognize 
its confidentiality, and agree to conduct the described 
study in compliance with Good Clinical Practice (GCP), 
ISO 14155, the ethical principles within the Declaration 
of Helsinki, this protocol, and all applicable regulatory 
requirements. Additionally, I will comply with all 
procedures for data recording and reporting, will permit 
monitoring, auditing, and inspection of my research 
center, and will retain all records until notified by the 
Sponsor. 
 
 
 
Principal Investigator: 
 
 
Signature 
 
 
 
 
Date 
Name and Investigator Number: 
 
Address: 
 
 
Telephone: 
 
 
 
Property of Alcon Laboratories 
ConfidentialMay not be used, divulged, published, or otherwise disclosed without the 
consent of Alcon Laboratories 

Document ID: 
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Status: Approved, Version: 10.0 
Approved Date: 02 Sep 2020 
Page 2 of 172 
 
Alcon – Business Use Only 
1 PROTOCOL SYNOPSIS 
Financial Disclosure 
for US FDA 
Submission Required? 
 
  X Yes  
No 
 
Test Article(s) / 
Product(s): 
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOLs (Models 
SND1T3, SND1T4, SND1T5, and SND1T6) and ACRYSOF IQ 
RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, 
SV25T5, and SV25T6), ACRYSOF IQ RESTOR +2.5 D Multifocal 
(Model SV25T0). 
The ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL 
(Models SND1T3/ SND1T4/ SND1T5/ SND1T6) is intended for 
primary implantation in the capsular bag of the eye for the visual 
correction of aphakia secondary to removal of a cataractous lens and 
pre-existing corneal astigmatism in adult patients with and without 
presbyopia, who desire near, intermediate, and distance vision, 
reduction of residual cylinder and increased spectacle independence. 
The lens is an ultraviolet and blue light filtering foldable multifocal 
toric IOL. The optical portion consists of a high refractive index 
material with proprietary blue light filtering chromophore which 
filters light in a manner that approximates the human crystalline lens 
in the 400-475 nm blue light wavelength range. In addition to 
standard UV absorption, the blue light filtering chromophore reduces 
transmittance of blue light wavelengths. The optical portion is 
biconvex and consists of a soft acrylic material capable of being 
folded prior to insertion, allowing placement through an incision 
smaller than the optic diameter of the lens. The biconvex optic 
contains an aspheric apodized diffractive structure on the anterior 
surface. After surgical insertion into the eye, the lens gently unfolds 
to restore the optical performance. The anterior surfaces of the 
ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL is designed 
with negative spherical aberration to compensate for the positive 
spherical aberration of the cornea. The toric posterior surface is 
designed to correct pre-existing corneal astigmatism. Alignment of 
the toric axis marks with the postoperative steep corneal meridian 
allows the lens to correct pre-existing corneal astigmatism. 
The ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs 
(Models SV25T3, SV25T4, SV25T5, and SV25T6) are intended for 
primary implantation in the capsular bag of the eye for the visual 
correction of aphakia secondary to removal of a cataractous lens and 
pre-existing corneal astigmatism in adult patients with and without 
presbyopia, who desire reduction of refractive cylinder and near, 
intermediate, and distance vision with increased spectacle 
independence. 

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Status: Approved, Version: 10.0 
Approved Date: 02 Sep 2020 
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The lens is an ultraviolet and blue light filtering foldable multifocal 
toric IOL. The optical portion consists of a proprietary high refractive 
index hydrophobic acrylic material with a blue light filtering 
chromophore which filters light in a manner that approximates the 
human crystalline lens in the 400-475 nm blue light wavelength 
range. The optical portion is biconvex and consists of a soft acrylic 
material capable of being folded prior to insertion, allowing 
placement through an incision smaller than the optic diameter of the 
lens. After surgical insertion into the eye, the lens gently unfolds to 
restore the optical performance. The biconvex optic contains an 
aspheric apodized diffractive structure with a central refractive zone 
on the anterior surface and a toric posterior surface. The apodized 
diffractive structure divides incoming light to provide a range of 
functional vision (defined as visual acuity of 20/40 or better) from 
distance to near. The anterior surface of the ACRYSOF IQ RESTOR 
+2.5 D Multifocal Toric IOL Models SV25T3 through SV25T6 is 
designed with negative spherical aberration to compensate for the 
positive spherical aberration of the cornea. The toric posterior surface 
is designed to correct pre-existing corneal astigmatism. Alignment of 
the toric axis marks with the postoperative steep corneal meridian 
allows the lens to correct pre-existing corneal astigmatism. The 
effects of this aspheric design feature have not been clinically 
assessed. Compared to other Alcon ACRYSOF IQ RESTOR 
Multifocal Toric IOL models (Models SND1T3 to SND1T6), these 
IOLs (Models SV25T3 to SV25T6) provide an alternate option for 
clinicians to offer patients with astigmatism with the near add power 
of +2.5 D, with optimal vision at 53 cm and greater distance 
dominance in the energy distribution between near and far. 
The ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model 
SV25T0) is intended for primary implantation in the capsular bag of 
the eye for the visual correction of aphakia secondary to removal of a 
cataractous lens in adult patients with and without presbyopia, who 
desire reduction of near, intermediate, and distance vision with 
increased spectacle independence. 
The lens is an ultraviolet and blue light filtering foldable multifocal 
IOL. The optical portion consists of a proprietary high refractive 
index hydrophobic acrylic material with a blue light filtering 
chromophore which filters light in a manner that approximates the 
human crystalline lens in the 400-475 nm blue light wavelength 
range. The optical portion is biconvex and consists of a soft acrylic 
material capable of being folded prior to insertion, allowing 
placement through an incision smaller than the optic diameter of the 
lens. After surgical insertion into the eye, the lens gently unfolds to 
restore the optical performance. The biconvex optic contains an 
aspheric apodized diffractive structure with a central refractive zone 
on the anterior surface and a posterior surface. The apodized 

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diffractive structure divides incoming light to provide a range of 
functional vision (defined as visual acuity of 20/40 or better) from 
distance to near. The anterior surface of the ACRYSOF IQ RESTOR 
+2.5 D Multifocal IOL Model SV25T0 is designed with negative 
spherical aberration to compensate for the positive spherical 
aberration of the cornea. The effects of this aspheric design feature 
have not been clinically assessed. Compared to other Alcon 
ACRYSOF RESTOR Multifocal IOL models (Models SN6AD1, 
MN6AD1 and SN6AD3), this IOL (Model SV25T0) provides an 
alternate option for clinicians to offer patients with the near add 
power of +2.5 D, with optimal vision at 53 cm and greater distance 
dominance in the energy distribution between near and far. 
 
Objective(s): 
To report the rate of post-surgical intraocular inflammation (based 
upon a specified case definition) reported within a 180-day 
post-surgical period following attempted implantation of an 
ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the 
US.  
Clinical Study Design: This is a prospective, multicenter, post-approval active surveillance 
study.  
No. of Eyes: 
Cohort 1: Adult subjects implanted with an ACRYSOF IQ RESTOR 
Toric Multifocal IOL (+3.0 D or +2.5 D) in at least one eye  
• Enrolled: 478 Subjects 
• Implanted: 706 eyes 
• Completed: 703 eyes  
 
 
Cohort 2: Adult subjects implanted with an ACRYSOF IQ RESTOR 
+3.0 D Multifocal Toric IOL or ACRYSOF IQ RESTOR +2.5 D 
Multifocal IOL in at least one eye 
• Enroll: Approximately 3600 eyes 
• Implant: Approximately 3300 eyes 
• Required for statistical analysis: 3000 completed eyes 
 
Region(s): 
US 
Clinical Study 
Duration: 
a) Total expected duration of the clinical investigation: 
Approximately 50 months 
b) Expected duration of each subject's participation: Approximately 
7 months per participating eye 
c) Planned follow up duration: 180 days per participating eye 

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d) Estimated time needed to select the number of eyes (ie, 
enrollment period): Approximately 47 months 
Clinical Study 
Population: 
Cohort 1: Adult subjects, 22 years of age or older, implanted from 
November 2018 through July 2020 with an ACRYSOF IQ RESTOR 
Multifocal Toric IOL (+3.0 D or +2.5 D)    
Cohort 2: Adult subjects, 22 years of age or older, implanted after 
July 2020 with an ACRYSOF IQ RESTOR +3.0 D Multifocal Toric 
IOL or ACRYSOF IQ RESTOR +2.5 D Multifocal IOL   
Treatments: 
Test Articles: 
ACRYSOF IQ RESTOR +3.0 D Multifocal 
Toric IOLs (Models SND1T3, SND1T4, 
SND1T5, and SND1T6)  
ACRYSOF IQ RESTOR +2.5 D Multifocal 
Toric IOLs (Models SV25T3, SV25T4, 
SV25T5, and SV25T6) 
ACRYSOF IQ RESTOR +2.5 D Multifocal 
(Model SV25T0) 
Administration: 
Routine small incision cataract surgery with 
IOL implantation. 
General Description: A range of commonly utilized spherical 
powers (diopters) will be available. 
Duration of 
Treatment: 
Intraocular lenses are implantable medical 
devices and are intended for long term use 
over the lifetime of the cataract subject. 
Control Article: 
N/A 
Administration: 
N/A 
General Description: N/A 
Duration of 
Treatment: 
N/A 
Inclusion & Exclusion 
Criteria: 
Details can be found in Section 10: Subject Population 
Performance 
N/A 
Safety 
Slit-lamp examination 
Problems during surgery 
Intraocular pressure (IOP) 
Aqueous cell 
Aqueous flare 
Corneal edema 

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Corneal haze 
Fibrin in anterior chamber, on the surface of the iris or on the IOL 
Eyelid edema 
Conjunctival hyperemia 
Ciliary flush 
Corneal precipitates 
Hypopyon 
Adverse events 
Device deficiencies 
Dilated Fundus Exam 
Vitreous haze 
Vitreous cell 
Subject Reported Symptoms 
Best Corrected Visual Acuity 
Other 
N/A 
Planned Analysis 
Safety data set 
Safety set includes all eyes with attempted test article implantation (successful or aborted 
after contact with the eye). The safety set will be used for all safety analyses including the 
primary safety endpoint analysis. Modified safety set includes all eyes with successful test 
article implantation. The modified safety set will be used for a sensitivity analysis of the 
primary safety endpoint. 
Primary Safety: 
The rate of post-surgical intraocular inflammation (based upon the specified case 
definition) reported within a 180-day post-surgical period following attempted 
implantation of an ACRYSOF IQ RESTOR Toric IOL or ACRYSOF IQ RESTOR IOL 
(Cohort 2) in the US will be estimated along with the exact two-sided 95% confidence 
interval (CI). The event rate (per 1,000 IOL implants) is 
Total # of reported events / Total # of implants  1,000. 
A subgroup analysis on the primary safety endpoint will be performed by age group 
(22-64 years vs. 65 years or older). If both eyes of a subject are enrolled in this study, full 
follow-up information for both eyes will be used in the primary analysis. As sensitivity 
analyses, two cumulative event rates at 180 days and the corresponding two-sided 95% 
confidence interval will be provided using Kaplan-Meier estimator: 
• Full follow-up information for both eyes is used 

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• If a subject has a second cataract surgery within 180 days of the occurrence of the 
first cataract surgery, the follow-up for the first eye will be censored at the time of 
second surgery 
Secondary Safety: 
The rates of Toxic Anterior Segment Syndrome, acute postoperative endophthalmitis, 
chronic postoperative endophthalmitis, and uncategorized cases of post-surgical intraocular 
inflammation (based upon the specified case definition), respectively, reported within a 
180-day post-surgical period following implantation of ACRYSOF IQ RESTOR Toric IOL 
or ACRYSOF IQ RESTOR IOL (Cohort 2) in the US will be estimated along with the 
exact two-sided 95% CI.  
 
 
 
 
  
 

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2 TABLE OF CONTENTS 
1 
PROTOCOL SYNOPSIS .................................................................................................... 2 
2 
TABLE OF CONTENTS ..................................................................................................... 8 
List of Tables ............................................................................................................................ 10 
List of Figures .......................................................................................................................... 11 
3 
ABBREVIATIONS ........................................................................................................... 12 
4 
GLOSSARY OF TERMS .................................................................................................. 13 
 
 
6 
SCHEDULE OF VISITS ................................................................................................... 37 
7 
INTRODUCTION ............................................................................................................. 39 
7.1 
Background........................................................................................................ 39 
7.2 
Clinical Study Design ........................................................................................ 39 
7.3 
Rationale for Study Design ............................................................................... 40 
7.4 
Study Milestones Timeline ................................................................................ 41 
8 
CLINICAL STUDY OBJECTIVES .................................................................................. 43 
8.1 
Primary Objective .............................................................................................. 43 
8.2 
Secondary Objectives ........................................................................................ 43 
8.3 
Exploratory Objectives ...................................................................................... 43 
8.4 
Study Endpoints................................................................................................. 43 
8.4.1 
Performance Endpoints ..................................................................... 43 
8.4.2 
Safety Endpoints ................................................................................ 43 
9 
INVESTIGATIONAL PLAN ............................................................................................ 46 
9.1 
Outline of Clinical Study ................................................................................... 46 
9.2 
Study Design ..................................................................................................... 46 
9.3 
Rationale for Study Design ............................................................................... 47 
9.4 
Procedures Per Study Visit ................................................................................ 47 
9.5 
Risk Benefit Assessment ................................................................................... 47 
9.6 
Study Recruitment and Entry ............................................................................ 49 
10 SUBJECT POPULATION ................................................................................................. 50 
10.1 Inclusion Criteria ............................................................................................... 50 
10.2 Exclusion Criteria .............................................................................................. 51 

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11 TREATMENT.................................................................................................................... 52 
11.1 Investigational Products .................................................................................... 52 
11.2 Usage 
53 
11.3 Supply 
54 
11.4 Dispensing ......................................................................................................... 55 
11.5 Accountability Procedures ................................................................................. 55 
11.6 Return of Test Article ........................................................................................ 55 
12 CLINICAL STUDY PROCEDURES ................................................................................ 56 
12.1 Clinical Study Assessments ............................................................................... 56 
12.1.1 
Screening/Pre-surgery Visit (Visit 0) ................................................. 56 
12.1.2 
Surgery Visit (Visit 00/Visit 00A) ..................................................... 57 
12.1.3 
Postoperative Visits ........................................................................... 58 
12.2 Unscheduled Visits ............................................................................................ 59 
12.3 Missed Visits ..................................................................................................... 60 
12.4 Discontinued Subjects ....................................................................................... 61 
12.5 Clinical Study Termination ................................................................................ 61 
13 DEVICE DEFICIENCIES AND ADVERSE EVENTS .................................................... 63 
13.1 General Information .......................................................................................... 63 
13.2 Specific Events Relevant to this Protocol ......................................................... 66 
13.3 Procedures for Recording and Reporting .......................................................... 66 
13.4 Unmasking of the Study Information ................................................................ 68 
13.5 Follow-Up of Safety Information ...................................................................... 68 
14 DATA REVIEW AND HANDLING ................................................................................. 69 
14.1 Completion of Source Documents and Case Report Forms .............................. 69 
14.2 Data Review and Clarifications ......................................................................... 70 
15 ANALYSIS PLAN ............................................................................................................ 71 
15.1 Subject Evaluability........................................................................................... 71 
15.2 Analysis Data Sets ............................................................................................. 71 
15.3 Demographics and Baseline Characteristics ..................................................... 71 
15.4 Performance Analyses ....................................................................................... 71 
15.4.1 
Primary Performance ......................................................................... 71 
15.4.1.1 
Statistical Hypotheses ........................................................ 71 
15.4.1.2 
Analysis Methods .............................................................. 72 

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15.4.2 
Secondary Performance ..................................................................... 72 
15.4.2.1 
Statistical Hypotheses ........................................................ 72 
15.4.2.2 
Analysis Methods .............................................................. 72 
 
 
 
 
 
 
15.5 Handling of Missing Data ................................................................................. 72 
15.6 Multiplicity ........................................................................................................ 72 
15.7 Safety Analysis .................................................................................................. 72 
15.8 Interim Analyses ................................................................................................ 74 
15.9 Adaptive Study Design ...................................................................................... 74 
15.10 Sample Size Justification ................................................................................... 74 
16 ADMINISTRATIVE PROCEDURES .............................................................................. 76 
16.1 Regulatory and Ethical Compliance .................................................................. 76 
16.2 Informed Consent Procedures ........................................................................... 76 
16.3 Responsibilities of the Investigator and IRB ..................................................... 77 
16.4 Sponsor and Monitoring Responsibilities ......................................................... 77 
16.5 Subject Confidentiality ...................................................................................... 78 
16.6 Regulatory Documentation and Records Retention .......................................... 78 
16.7 Clinical Study Results ....................................................................................... 79 
16.8 Publication of the Clinical Study ....................................................................... 79 
 
18 APPENDICES ................................................................................................................... 82 
Appendix A: Directions for Use for ACRYSOF IQ RESTOR +3.0 D Multifocal Toric 
IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) ................................. 82 
Appendix B: Directions for Use for ACRYSOF IQ RESTOR +2.5 D Multifocal Toric 
IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) ............................. 115 
Appendix C: Directions for Use for ACRYSOF IQ RESTOR +2.5 D Multifocal IOL 
(Model SV25T0) ............................................................................................. 153 
 
List of Tables 
Table 7–1 
Study Milestones .............................................................................................. 41 
Table 9–1 
Visit Schedule for 1st and 2nd Implant .............................................................. 47 

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List of Figures 
Figure 7–1 
Study Design .................................................................................................... 42 
Figure 13–1 
Categorization of All Adverse Events .............................................................. 63 
Figure 13–2 
Categorization of All Serious Adverse Events ................................................. 63 
Figure 15–1 
The exact two-sided 95% confidence intervals with N = 3,000 when the 
observed rate ranges from 1 to 10 (per 1,000) ................................................. 75 
 

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3 ABBREVIATIONS 
Abbreviation 
Definition 
ADE 
Adverse device effect 
AE 
Adverse event 
ASADE 
Anticipated serious adverse device effect 
BCVA 
Best corrected visual acuity 
CI 
Confidence interval 
CFR 
Code of Federal Regulations 
CRF 
Case report form 
CM 
Clinical Manager 
cm 
Centimeter 
CSM 
Clinical Site Manager 
D 
Diopters 
DFU 
Directions for use 
eCRF 
Electronic case report form 
EDC 
Electronic data capture 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
IEC 
Independent ethics committee 
ICF 
Informed consent form 
IRB 
Institutional review board 
IOL 
Intraocular lens 
IOP 
Intraocular pressure 
ISO 
International Organization for Standardization 
LCSM 
Lead Clinical Site Manager 
MD 
Doctor of medicine 
MedDRA® 
Medical Dictionary for Regulatory Activities 
mm 
Millimeters 
MOP 
Manual of procedures 
N 
Number 
N/A 
Not applicable 
nm 
Nanometer 
PAS 
Post-approval study 
PMA-S 
Premarket approval supplement 
SAE 
Serious adverse event 
SADE 
Serious adverse device effect 
SOP 
Standard operating procedures 
SSI 
Secondary surgical intervention 
TASS 
Toxic Anterior Segment Syndrome  
UNSV 
Unscheduled visit 
US 
United States 
USADE 
Unanticipated serious adverse device effect 
UV 
Ultraviolet 
WHO 
World Health Organization 

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4 GLOSSARY OF TERMS 
Adverse Device 
Effect (ADE) 
Adverse event related to the use of an investigational medical device 
or comparator, if applicable. Note: This definition includes adverse 
events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation; any 
malfunction; and use error or intentional misuse of the 
investigational medical device or comparator, if applicable. 
Adverse Event 
(AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in 
subjects, users or other persons, whether or not related to the 
investigational medical device. Note: For subjects, this definition 
includes events related to the investigational medical device or the 
procedures involved. For users or other persons, this definition is 
restricted to events related to investigational medical devices. 
Anticipated 
Serious Adverse 
Device Effect 
(ASADE) 
Serious adverse device effect which by its nature, incidence, severity, 
or outcome has been identified in the risk analysis. 
Assessment 
A procedure used to generate data required by the study. 
Device Deficiency  Inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. Note: This definition 
includes malfunctions, misuse or use errors, and inadequate labeling. 
Exposed 
The investigational product touched the subject’s eye 
Performance 
(Clinical) 
Behavior of a medical device or response of the subject to that 
medical device in relation to its intended use, when correctly applied 
to appropriate subjects. 
Malfunction 
Failure of an investigational medical device to perform in accordance 
with its intended purpose when used in accordance with the 
instructions for use or clinical investigation plan. 
Nonserious 
Adverse Event 
Adverse event that does not meet the criteria for a serious adverse 
event. 
Period 
A minor subdivision of the study timeline; divides phases into smaller 
functional segments such as screening, baseline, operative, 
postoperative, etc. 
Serious Adverse 
Device Effect 
(SADE) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 

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Serious Adverse 
Event (SAE) 
Adverse event that led to any of the following:  
• Death. 
• A serious deterioration in health that either resulted in: 
• a life-threatening illness or injury. 
Note: Life-threatening means that the individual was at 
immediate risk of death from the event as it occurred, ie, it 
does not include an event which hypothetically might have 
caused death had it occurred in a more severe form. 
• any potentially sight-threatening event or permanent 
impairment to a body structure or a body function. 
• in-patient hospitalization or prolonged hospitalization. 
Note: Planned hospitalization for a pre-existing condition, 
or a procedure required by the clinical investigation plan, 
without serious deterioration in health, is not considered a 
serious adverse event. In general, hospitalization signifies 
that the individual remained at the hospital or emergency 
ward for observation and/or treatment (usually involving 
an overnight stay) that would not have been appropriate in 
the physician's office or an out-patient setting. 
Complications that occur during hospitalization are AEs. If 
a complication prolongs hospitalization or fulfills any other 
serious criteria, the event is serious. When in doubt as to 
whether “hospitalization” occurred, the event should be 
considered serious. 
• a medical or surgical intervention to prevent a) or b). 
• any indirect harm as a consequence of incorrect diagnostic 
test results when used within manufacturer's instructions 
for use. 
• Fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
Subject Number 
A number assigned to each subject who enrolls in the study. When 
combined with the site number, a unique identifier is created for each 
subject in the study. 
Unanticipated 
Serious Adverse 
Device Effect 
(USADE) 
Serious adverse device effect which by its nature, incidence, severity 
or outcome has not been identified in the risk analysis. 
 

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6 SCHEDULE OF VISITS 
Procedure/ 
Assessment 
Visit 0 
(≤ 40 days 
pre-surgery 
1st eye, 
≤ 60 days 
pre-surgery 
2nd eye) 
Visit 00 & 
Visit 00A 
(surgery) 
Visit 1 & 
Visit 1A 
(Day 1-2 
post 
surgery) 
Visit 2 & 
Visit 2A 
(Day 7-14 
post 
surgery) 
Visit 3 & 
Visit 3A 
(Day 30-
60 post 
surgery) 
Visit 4 & 
Visit 4A 
(Day 90 -
180 post 
surgery) 
UNSV 
Informed 
Consent 
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Patient Medical 
History (Ocular 
and Nonocular)3 
X 
 
 
 
 
 
 
Medications (use 
of medication 
prior to, during 
and post-surgery 
must be 
documented)3 
X 
X 
X 
X 
X 
X 
X 
Inclusion/ 
Exclusion 
X 
X 
 
 
 
 
 
Adverse Events 
(Volunteered and 
Elicited) 
X 
X 
X 
X 
X 
X 
X 
Device 
Deficiencies 
 
X 
X 
X 
X 
X 
X 
Subject Reported 
Symptoms 
X 
 
X 
X 
X 
X 
X 
Best Corrected 
Visual Acuity 
(BCVA) 
X 
 
X 
X 
X 
X 
X 
Intraocular 
Pressure 
X 
 
X 
X 
X 
X 
X 
Problems during 
surgery 
 
X 
 
 
 
 
 
Other Surgical 
Procedures 
 
X 
 
 
 
 
 
Aqueous cell  
X 
 
X 
X 
X 
X 
X 
Aqueous flare  
X 
 
X 
X 
X 
X 
X 
Corneal edema 
X 
 
X 
X 
X 
X 
X 
Corneal haze 
X 
 
X 
X 
X 
X 
X 
Fibrin in the 
anterior chamber, 
on the surface of 
the iris or on the 
intraocular lens 
(IOL) 
X 
 
X 
X 
X 
X 
X 
Eyelid edema 
X 
 
X 
X 
X 
X 
X 

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Procedure/ 
Assessment 
Visit 0 
(≤ 40 days 
pre-surgery 
1st eye, 
≤ 60 days 
pre-surgery 
2nd eye) 
Visit 00 & 
Visit 00A 
(surgery) 
Visit 1 & 
Visit 1A 
(Day 1-2 
post 
surgery) 
Visit 2 & 
Visit 2A 
(Day 7-14 
post 
surgery) 
Visit 3 & 
Visit 3A 
(Day 30-
60 post 
surgery) 
Visit 4 & 
Visit 4A 
(Day 90 -
180 post 
surgery) 
UNSV 
Conjunctival 
hyperemia 
X 
 
X 
X 
X 
X 
X 
Ciliary flush 
X 
 
X 
X 
X 
X 
X 
Corneal 
precipitates 
X 
 
X 
X 
X 
X 
X 
Hypopyon 
X 
 
X 
X 
X 
X 
X 
Dilated fundus 
examination 
X 
 
X1 
X1 
X1 
X1 
X1 
Vitreous cell 
X 
 
X1 
X1 
X1 
X1 
X1 
Vitreous haze 
X 
 
X1 
X1 
X1 
X1 
X1 
Photo 
documentation  
 
 
X2 
X2 
X2 
X2 
X2 
Culture of ocular 
media 
 
 
X2 
X2 
X2 
X2 
X2 
1 Required for cases of exacerbated post-surgical intraocular inflammation only. 
2 Required at certain visits for cases of exacerbated post-surgical intraocular inflammation. See 
Manual of Procedures for details on requirements for which visit(s) testing is required.  
3 Concomitant medications and medical history must be fully documented in the subject 
source documents. CRF data will be Targeted:  
• Medical History: All ocular history, targeted systemic history 
• Concomitant Medications: All ocular medications, targeted systemic medications   
 
NOTE: Visits with an “A” refer to visits for the 2nd eye visits for cases where both eyes of a subject 
are enrolled. In the eCRF these visits will be noted with wording of “2nd Eye” instead of A. For 
example: Visit 1A will be shown as Visit 1-2nd Eye. 
 
 

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7 INTRODUCTION 
7.1 Background 
The ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL and ACRYSOF IQ RESTOR 
+2.5 D Multifocal Toric IOL are intended to provide astigmatic cataract patients with a range 
of near, intermediate and distance vision as well as correct the pre-existing corneal 
astigmatism by combining multifocal and toric optical designs. ACRYSOF IQ RESTOR +3.0 
D Multifocal Toric IOL Models SND1T3 – SND1T6 were approved in the United States on 
22 December 2016. The ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL Models 
SV25T3-T6 were approved in the United States on 21 March 2017. The ACRYSOF IQ 
RESTOR +2.5 D Multifocal IOL Model SV25T0 was approved in the United States on 13 
April 2015.  
Multifocal IOLs are designed to provide improved overall vision at near and intermediate 
distances when compared to conventional monofocal IOLs (Javitt 2000, Chiam 2006, 
Kohnen 2006, Souza 2006, Vingolo 2007, Alfonso 2009). Toric intraocular lenses correct 
aphakia as well as any pre-existing or surgically induced corneal astigmatism (Horn 2007, 
Bauer 2008). This provides a benefit to patients due to freedom from spectacles for distance 
vision which is an important consideration when choosing an intraocular lens (Lane 2006, 
Larendeau 2009).  
A summary of known and potential risks and benefits to humans, as identified in the literature 
or through preclinical testing and/or prior clinical evaluations, for each investigational 
product can be found in the Package Insert for the corresponding model. 
Risks associated with participation in the clinical investigation including risks associated with 
the clinical procedure are described in the Informed Consent Form (ICF). Information on 
alternative treatments that may be available to the subjects is also addressed in the ICF. 
7.2 Clinical Study Design 
This is a prospective, multi-center, active surveillance post-approval study designed to 
estimate the incidence of post-surgical intraocular inflammation (based upon a specific case 
definition) in approximately 3,000 eyes that have been implanted with an ACRYSOF IQ 
RESTOR Toric IOL or ACRYSOF IQ RESTOR Multifocal IOL 
 
 for up to 180 days. Active surveillance will 
be conducted through systematic collection, analysis, and interpretation of all reported cases 
of post-surgical intraocular inflammation over 4 visits ranging from 1 to 180 days post 
implantation of the ACRYSOF IQ RESTOR Toric IOL or ACRYSOF IQ RESTOR IOL in the 

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US. The ACRYSOF IQ RESTOR Toric IOL and ACRYSOF IQ RESTOR IOL are 
commercially available in the United States. This study will include adults (≥ 22 years of age) 
with preoperative cataract in the study eye(s). Potential subjects will be screened for 
enrollment into the study. Those qualifying will be considered enrolled in the study at the 
time the informed consent form is signed, and attend a total of up to 11 visits. The subject 
will be considered exposed to treatment at the time of surgery when the investigational 
product touches the eye. 
The study includes two groups of subjects (Cohort 1, and Cohort 2).  
Cohort 1: Subjects implanted from November 2018 through July 2020 with an ACRYSOF IQ 
RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5, or SND1T6) 
or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL (Models SV25T3, SV25T4, 
SV25T5, and SV25T6) in at least one eye.   
Note: At time of Protocol Amendment 7, Cohort 1 enrollment, is complete. 
Cohort 2: Subjects implanted after July 2020 with an ACRYSOF IQ RESTOR +3.0 D 
Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF 
IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in at least one eye.   
Note:  This Cohort will include subjects enrolled under Amendment 7. 
Interim reports pertaining to the progress of the post-approval study will be submitted to the 
FDA for review every six months up to the first 2 years, or as requested, starting from the 
date of approval of the ACRYSOF IQ RESTOR +3.0 D Toric intraocular lens, and will 
continue to be submitted annually thereafter until study completion. 
 
7.3 Rationale for Study Design 
This study is designed in accordance with Alcon’s agreement with the United States FDA, 
subsequent to approval of the ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL. 
This study is being conducted as a post-approval surveillance study to comply with the 
request of the FDA approval of the AcrySof IQ ReSTOR +3.0 D Multifocal Toric IOL.  
Enrollment for this study originally started in November 2018. 
 
 
 
 
 

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.    
From November 2018 to November 2019 a total of 706 eyes in 478 subjects were 
successfully implanted with ReSTOR Toric IOLs 
 
These subjects comprise Cohort 1 and have been followed as defined 
in this protocol through their last study visit.  
Note: At time of Protocol Amendment 7, Cohort 1 enrollment, including subjects implanted 
and followed from November 2018 through July 2020, is complete. 
At the request of the FDA, Alcon is restarting enrollment in this study and all future subjects 
(approximately 3300) will be implanted with ACRYSOF ReSTOR Toric IOLs or ACRYSOF 
ReSTOR IOLs 
 
 These newly enrolled subjects will be Cohort 2 and will make up the primary study 
population.  
7.4 Study Milestones Timeline 
The study milestone timeline presented below is based upon the expectation that, following 
the initiation of the first site for enrolling each Cohort, the remaining study sites will be 
activated at a rate of approximately 5 per month, and the enrollment rate at activated sites 
will be approximately 6 eyes per month.  
Table 7–1 
Study Milestones 
Key Milestone 
Target Date (Cohort 1) 
Target Date (Cohort 2) 
First Site Initiated 
November 2018 
October 2020 
First Subject First Visit 
November 2018 
October 2020 
Last Subject First Visit 
  November 2019 
June 2022 
Last Subject Last Visit 
 July 2020 
January 2023 
Database Lock 
July 2020 
January 2023 
Submit PAS Final Report 
April 2023 
 
 

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8 CLINICAL STUDY OBJECTIVES 
8.1 Primary Objective 
The primary objective is to report the rate of post-surgical intraocular inflammation (based 
upon a specified case definition) reported within a 180-day post-surgical period following 
attempted implantation of an ACRYSOF IQ RESTOR Toric IOL or ACRYSOF IQ ReSTOR 
IOL in the US. 
8.2 Secondary Objectives 
Not applicable 
8.3 Exploratory Objectives 
Not applicable 
8.4 Study Endpoints 
8.4.1 
Performance Endpoints 
There are no performance endpoints in this study. 
8.4.2 
Safety Endpoints 
The primary safety endpoint is the rate (per 1,000 IOL implants) of post-surgical 
intraocular inflammation (based upon the specified case definition) reported within a 180-day 
post-surgical period following attempted implantation of ACRYSOF IQ RESTOR Toric +3.0 
D Multifocal IOL or ACRYSOF IQ ReSTOR +2.5 D Multifocal IOL (Cohort 2).  
The specific case definition of post-surgical intraocular inflammation is as follows. 
Exacerbated intraocular inflammation within 180 days after IOL implantation as indicated by:  
• ≥ 3+ aqueous cell within the first 14 days post-op (collected at Visit 1 or 2 or at an 
unscheduled visit between Visit 00 and Visit 2), and/or 
• ≥ 2+ aqueous cell ˃ 14 days and ≤ 60 days post-op (collected on Visit 3 or at an 
unscheduled visit between Visit 2 and Visit 3), and/or 
• ≥ 1+ aqueous cell ˃ 60 days post-op or later (collected on Visit 4 or at an unscheduled 
visit between Visit 3 and Visit 4) 
 

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The secondary safety endpoints are the rates (per 1,000) of Toxic Anterior Segment 
Syndrome (TASS), acute postoperative endophthalmitis, chronic postoperative 
endophthalmitis, and uncategorized cases of post-surgical intraocular inflammation (based 
upon the specified case definition), respectively, reported within a 180-day post-surgical 
period following implantation of ACRYSOF IQ RESTOR Toric IOLs or ACRYSOF IQ 
ReSTOR IOL (Cohort 2).  
The case definitions of TASS and endophthalmitis are as follows: 
Exacerbated intraocular inflammation within 180 days after IOL implantation associated with 
the following findings: 
TASS 
• ≥ 3+ aqueous cell  
• Non-infectious etiology 
• Rapid onset (up to and including 2 days postoperatively) 
ACUTE POSTOPERATIVE ENDOPHTHALMITIS 
• ≥ 3+ aqueous cell 
• Etiology 
o Infectious per positive culture of ocular media 
o Non-infectious per negative culture of ocular media 
• Inflammatory cells in the vitreous and/or vitreous abscess. 
• Rapid onset (3 to 14 days postoperatively) 
CHRONIC POSTOPERATIVE ENDOPHTHALMITIS 
• ≥ 1+ aqueous cell  
• Etiology 
o Infectious per positive culture of ocular media 
o Non-infectious per negative culture of ocular media 
• Inflammatory cells in the vitreous 
• Delayed onset (˃ 14 days postoperatively) 
UNCATEGORIZED 
• Exacerbated intraocular inflammation within 180 days after IOL implantation as 
indicated by: 
• ≥ 3+ aqueous cell within the first 14 days post-op (collected on Visit 1 or 2 or 
at an unscheduled visit between Visit 00 and Visit 2), and/or 

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• ≥ 2+ aqueous cell ˃ 14 days and ≤ 60 days post-op (collected on Visit 3 or at 
an unscheduled visit between Visit 2 and Visit 3), and/or 
• ≥ 1+ aqueous cell ˃ 60 days post-op or later (collected on Visit 4 or at an 
unscheduled visit between Visit 3 and Visit 4).  
but does not meet the definitions for TASS, acute postoperative endophthalmitis, or 
chronic postoperative endophthalmitis given above. 
 
 
 
. 

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9 INVESTIGATIONAL PLAN 
9.1 Outline of Clinical Study 
This is a prospective, multi-center, active surveillance post-approval study, designed to 
estimate the incidence of post-surgical intraocular inflammation (based upon a specific case 
definition) in approximately 3,000 eyes that have been implanted with an ACRYSOF IQ 
RESTOR Toric IOL or ACRYSOF IQ RESTOR IOL (Cohort 2) for up to 180 days. 
9.2 Study Design 
The study will include adults (≥ 22 years of age) who plan to have cataract extraction and 
subsequent implantation of an ACRYSOF IQ RESTOR +3.0 D Toric Multifocal IOL (Models 
SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Toric IOL 
(Models SV25T3, SV25T4, SV25T5, and SV25T6) or an ACRYSOF IQ RESTOR +2.5 D 
Multifocal IOL (Model SV25T0) in at least one eye. Potential subjects will be screened for 
eligibility and enrollment into the study. In Cohort 1, 706 eyes were implanted, and 
approximately 3600 eyes will be screened, to identify 3300 qualified eyes in Cohort 2. Within 
40 days of screening, qualified subjects will receive cataract surgery followed by 
implantation at the surgery visit with one of the study IOLs for their Cohort as follows: 
Cohort 1: Subjects implanted from November 2018 through July 2020 with an ACRYSOF IQ 
RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5, or SND1T6) 
or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL (Models SV25T3, SV25T4, 
SV25T5, and SV25T6) in at least one eye.   
 
Cohort 2: Subjects implanted after July 2020 with an ACRYSOF IQ RESTOR +3.0 D 
Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5, or SND1T6) or an ACRYSOF 
IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in at least one eye.   
 
If a second eye will participate in the study, subjects will receive the second eye cataract 
surgery within 60 days of the screening Visit 0. Four postoperative follow-up visits are 
planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. 
Subject participation in this study is expected to last up to 7 months, including a total of 6 
study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in 
both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the 
study. 

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Table 9–1 
Visit Schedule for 1st and 2nd Implant 
Time From Implantation 
1st Implant 
2nd Implant 
Pre-surgery 
Visit 0 
- 
Surgery 
Visit 00 
Visit 00A 
1-2 days 
Visit 1 
Visit 1A 
7-14 days 
Visit 2 
Visit 2A 
30-60 days 
Visit 3 
Visit 3A 
90-180 days 
Visit 4 
Visit 4A 
9.3 Rationale for Study Design 
This study is designed in accordance with Alcon’s agreement with the United States FDA, 
subsequent to approval of the ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL. 
9.4 Procedures Per Study Visit 
Section 12, Clinical Study Procedures, contains procedures per study visits. 
9.5 Risk Benefit Assessment 
The ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL is intended for primary 
implantation in the capsular bag of the eye for the visual correction of aphakia secondary to 
removal of a cataractous lens and pre-existing corneal astigmatism in adult patients with and 
without presbyopia, who desire near, intermediate and distance vision, reduction of residual 
refractive cylinder and increased spectacle independence. The lens is intended to be placed in 
the capsular bag. 
The ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, 
SV25T5, and SV25T6) are intended for primary implantation in the capsular bag of the eye 
for the visual correction of aphakia secondary to removal of a cataractous lens and 
pre-existing corneal astigmatism in adult patients with and without presbyopia, who desire 
reduction of refractive cylinder and near, intermediate, and distance vision with increased 
spectacle independence. 

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The ACRYSOF IQ RESTOR +2.5 D Multifocal IOLs (Model SV25T0) are intended for 
primary implantation in the capsular bag of the eye for the visual correction of aphakia 
secondary to removal of a cataractous lens in adult patients with and without presbyopia, who 
desire near, intermediate, and distance vision with increased spectacle independence. 
During the development of ACRYSOF IQ RESTOR Toric IOL, the safety and performance 
aspects of the device have been evaluated using risk analysis techniques, and clinical hazards 
are addressed by the pivotal clinical study data. 
In the pivotal clinical study for the ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL, the 
safety and performance of ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL was 
demonstrated. The study results demonstrated that the benefit of ACRYSOF IQ RESTOR 
+3.0 D Toric IOL implantation at the time of cataract surgery in subjects with aphakia and 
pre-existing corneal astigmatism outweigh its risks. FDA’s approval was obtained on 22 
December 2016 for commercial distribution.  
No pivotal clinical study for the ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL was 
conducted. However, the pivotal clinical study for the non-toric ACRYSOF IQ RESTOR 
+2.5 D IOL (SV25T0) in conjunction with the pivotal clinical study for ACRYSOF IQ 
RESTOR +3.0 D Toric IOL (T3-T6) demonstrate safety and performance of the ACRYSOF 
IQ RESTOR +2.5 D Toric IOL. Both studies show the benefit of the ACRYSOF IQ RESTOR 
+2.5 D Toric IOL, which outweigh its risks. FDA approval was obtained on 21 March 2017.  
The pivotal clinical study for the ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (SV25T0 
demonstrated safety and performance of the ACRYSOF IQ RESTOR +2.5 D Multifocal IOL.  
and showed the benefit of the ACRYSOF IQ RESTOR +2.5 D Multifocal IOL outweigh its 
risks. FDA approval was obtained on 13 April 2015. 
In accordance with order, this post-approval study is being conducted to provide continued 
reasonable assurance of safety of the ACRYSOF IQ RESTOR +3.0 D Toric IOL. 
 
 
 
 
   
In the post-approval clinical study, a careful evaluation will be performed according to the 
inclusion/exclusion criteria to ensure that vulnerable or inappropriate subjects are not allowed 
to participate in the clinical study. Subject safety will be monitored closely via the collection 

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of adverse events, and safety parameter assessments at postoperative visits (either planned or 
unscheduled) throughout the course of the study. 
Overall, the information that will be gained in the post-approval study will provide continued 
evidence supporting safety of the device. 
9.6 Study Recruitment and Entry 
Participants will be recruited from the Investigators’ patient population, referrals, or IRB 
approved materials. Patients that appear to be eligible subjects will be approached for study 
participation and sign an Informed Consent Form (ICF) prior to the commencement of study 
related procedures. 
The Investigator or designee will explain the study purpose, procedures and subject 
responsibilities to the potential participant. The subject must be given the opportunity to ask 
questions and allowed time to consider the information provided. The subject’s willingness 
and ability to meet the follow-up requirements will be determined. When it has been 
established that the subject is eligible for possible participation in the study, written informed 
consent will be obtained. Upon signing the ICF, the subject will be enrolled into the study. 
The original signed informed consent form will be retained within the subject’s medical 
records, and a copy will be provided to the subject. 

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10 SUBJECT POPULATION 
The study population includes two Cohorts (Cohort 1 and 2) to be implanted at 
approximately 30 sites. To participate in the clinical study, subjects must be 22 years of age 
or older and have planned implantation in at least one eye with one of the study IOLs for 
their Cohort as follows: 
Cohort 1: Subjects implanted from November 2018 through July 2020 with an ACRYSOF IQ 
RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5, or SND1T6) 
or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, 
SV25T5, and SV25T6) in at least one eye, in accordance with the product labeling.  
Note: At time of Protocol Amendment 7 Cohort 1 enrollment, is complete. 
Cohort 2: Subjects implanted after July 2020 with ACRYSOF IQ RESTOR +3.0 D 
Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF 
IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in at least one eye, in accordance with 
the product labeling.  
           Note:  This Cohort will include subjects enrolled under Amendment 7. 
The subject must not have ocular or intraocular infection or inflammation at the screening 
visit or on the day of surgery, nor any history of intraocular inflammation within the past 12 
months. A subject can have one eye or both eyes enrolled in the study if the eye(s) meets the 
required qualifications. Additional entry criteria are listed below in Sections 10.1 and 10.2. 
The study enrollment period is expected to last approximately  43 months. 
Check all entry criteria at screening/pre-surgery (Visit 0) and at both surgical visits (Visit 00, 
Visit 00A). If a subject reschedules surgery, resulting in the pre-surgery study assessments 
(Visit 0) falling outside of the required window; the pre-surgery study assessments should be 
repeated and inclusion/exclusion criteria re-verified. Subjects failing to pass entry criteria 
may not be re-screened. 
10.1 Inclusion Criteria 
Below is a list of the inclusion criteria. Assessments must be performed at screening (Visit 0), 
unless otherwise indicated. 
1. Adults, 22 years of age or older, of either gender or any race, with preoperative 
cataract in the study eye(s). 

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2. Subjects with planned implantation in at least one eye with: 
Cohort 1: an ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models 
SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D 
Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in 
accordance with the product labeling from November 2018 to July 2020 
Cohort 2: an ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models 
SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D 
Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 
2020. [Note: powers supplied are +15.0 D to +25.0 D in 0.5 D increments.] 
3. Able to comprehend and sign a statement of informed consent 
4. Willing and able to complete all required postoperative visits 
 
10.2 Exclusion Criteria 
Below is a list of exclusion criteria.  
1. Eyes with clinically significant ocular, including adnexa, or intraocular infection or 
inflammation (at the screening visit prior to surgery or on the day of surgery) 
2. Subjects with a history of any intraocular inflammation within the past 12 months 
(ex: uveitis, choroiditis) 
3. Combined procedures introducing an additional medical device during cataract 
surgery (ex: cataract surgery with implant of glaucoma stent)  
 

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11 TREATMENT 
Upon signing the informed consent form, subjects are considered enrolled in the study. All 
enrolled subjects will be assigned a unique subject identifier at the screening visit, which will 
be used throughout the clinical study. The subject identifier consists of a combination of a 
four digit Investigator number and a five-digit subject number (Cohort 1) and a five digit 
Investigator number and a five-digit subject number (Cohort 2). The number is automatically 
generated sequentially by the EDC system. As an example: “1234.00001” or “01234.00001” 
(the Investigator number and subject number are separated by a “.” character).  
Subjects are considered exposed to treatment in the study at the time of surgery, when the 
investigational product touches the eye. Throughout the clinical study, the Investigator will be 
responsible for ensuring that the investigational products are used in accordance with product 
labeling. 
11.1 Investigational Products 
Test Articles: ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, 
SND1T4, SND1T5 or SND1T6), ACRYSOF IQ RESTOR +2.5 D Toric IOL (Models 
SV25T3, SV25T4, SV25T5, and SV25T6), and ACRYSOF IQ RESTOR +2.5 D 
Multifocal IOL (Model SV25T0) manufactured by Alcon Laboratories, Inc. These products 
are approved by FDA in United States.  
The ACRYSOF IQ RESTOR Toric IOL is intended for primary implantation in the capsular 
bag of the eye for the visual correction of aphakia and pre-existing corneal astigmatism 
secondary to removal of a cataractous lens in adult patients with and without presbyopia, who 
desire near, intermediate, and distance vision, reduction of residual refractive cylinder, and 
increased spectacle independence. The test articles are manufactured by Alcon Laboratories, 
Inc.,  are of single piece construction, and have a 6.0 mm diameter biconvex optic and an 
overall length of 13.0 mm. The haptics are made of the same material as the optic with no 
angulation. ACRYSOF IQ RESTOR +3.0 D Toric IOL (Models SND1T3, SND1T4, SND1T5 
or SND1T6) will be available in lens power ranges 10.0 D to 30.0 D (Cohort 1) and 15.0 D to 
25.0 D (Cohort 2) in 0.5 D increments. ACRYSOF IQ RESTOR +2.5 D Multifocal Toric 
IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) will be available in lens power 
ranges 6.0 D to 30.0 D in 0.5 D increments for Cohort 1 only. Note: At time of Protocol 
Amendment 7, Cohort 1 enrollment is complete.  

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The posterior surface of the ACRYSOF IQ RESTOR Toric IOL is marked with six 
indentations (three on either side) on the flatter meridian of the optic. These indentations on 
the periphery of the optic are to be aligned with the axis determined by the Alcon Online 
Toric IOL Calculator (http://www.myalcon-toriccalc.com).  
The ACRYSOF IQ RESTOR IOL is intended for primary implantation in the capsular bag of 
the eye for the visual correction of aphakia secondary to removal of a cataractous lens in 
adult patients with and without presbyopia, who desire near, intermediate, and distance vision 
and increased spectacle independence. The test articles are manufactured by Alcon 
Laboratories, Inc., are of single piece construction, have a 6.0 mm diameter biconvex optic 
and an overall length of 13.0 mm. The haptics are made of the same material as the optic with 
no angulation. ACRYSOF IQ RESTOR +2.5 D Multifocal IOLs (Model SV25T0) will be 
available in lens power ranges 15.0 D to 25.0 D in 0.5 D increments for Cohort 2 enrollment. 
 
 
Each IOL will have a unique serial number. The IOL package will contain: 
The IOL, 
A subject registration card (Lens Implant Card) 
A subject identification card to be given to the subject after surgery, 
Adhesive labels containing the IOL information (including the unique serial number) 
A package insert containing directions for use 
Control Article: Not applicable. 
There is no control article in this study. 
11.2 Usage 
The AcrySof IQ ReSTOR Toric Intraocular Lens (IOL) is intended for primary implantation 
in the capsular bag of the eye for the visual correction of aphakia and pre-existing corneal 
astigmatism secondary to removal of a cataractous lens in adult patients with and without 
presbyopia, who desire near, intermediate, and distance vision, reduction of residual 

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refractive cylinder and increased spectacle independence. The lens is intended to be placed in 
the capsular bag. 
The AcrySof IQ ReSTOR IOL is intended for primary implantation in the capsular bag of the 
eye for the visual correction of aphakia secondary to removal of a cataractous lens in adult 
patients with and without presbyopia, who desire near, intermediate, and distance vision with 
increased spectacle independence. It is recommended to implant ACRYSOF IQ RESTOR 
+2.5 D Multifocal IOL in subjects with < 1.0 D astigmatism. 
In order to implant the test article, the surgeons participating in the study must be licensed 
ophthalmologists with cataract surgery experience. Each surgeon will use his/her standard of 
care to implant the lens following the Package Insert/DFU for the device. 
NOTE: If problems during surgery occur or other surgical procedures are performed prior to 
implanting the IOL, determine whether the lens should be implanted as recommended in the 
product DFU and Inclusion/Exclusion criteria listed in Section 10 
 
11.3 Supply  
The Sponsor will provide a consignment of the ACRYSOF IQ RESTOR +3.0 D Multifocal 
Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) and ACRYSOF IQ RESTOR 
+2.5 D Multifocal IOL (Model SV25T0) to each investigative site free of charge for Cohort 2 
only in the ranges described in Table 11-1.  
Table 11-3       ACRYSOF IQ RESTOR IOL Models and Optic Power Ranges 
IOL Model 
Optic Powers supplied 
RESTOR +3.0 D Multifocal Toric IOL (Models 
SND1T3, SND1T4, SND1T5 or SND1T6) 
+15.0 D to  25.0 D ( 0.5 D increments) 
RESTOR +2.5 D Multifocal IOL (Model 
SV25T0) 
+15.0 D to 25.0 D ( 0.5 D increments) 
 
The Investigator is responsible for maintaining the consignment, ensuring that an adequate 
number of IOLs are available in each dioptric power provided by the Sponsor. To obtain 
additional IOLs, the Investigator must contact the Sponsor.   
Storage instructions for the study IOLs can be found in the ACRYSOF IQ ReSTOR +3.0 D 
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11.4 Dispensing 
The Investigator is to keep a current record of dispensing of all test articles. This record will 
be made available to the Sponsor’s monitor to account for all test articles. 
If an Investigative Site has more than one study surgeon, each surgeon (maximum of 4 per 
site) will be assigned a surgeon number (eg, 01, 02) and this will be documented on the 
appropriate log. If the Investigative Site has only one surgeon his/her surgeon number is 01. 
11.5 Accountability Procedures 
Upon receipt of the IOLs for Cohort 2, the Investigator or delegate must conduct an inventory 
of  the IOLs by serial number, complete study specific confirmation of receipt procedures as 
described in the MOP, and retain any required documentation in the Investigator’s clinical 
study records. Throughout the study, the Investigator or delegate must maintain records of 
IOL use/dispensation for each subject. This record must be made available to the study 
monitor for the purposes of verifying the accounting of IOL supplies. Any discrepancies 
and/or deficiencies between the observed disposition and the written account must be 
recorded along with an explanation. All IOLs sent to the Investigator must be accounted for 
by Study Sponsor personnel, and in no case be used in an unauthorized manner. 
The Investigator is responsible for proper disposition of all unused IPs at the conclusion of 
the study, according to the instructions provided in the MOP. 
11.6 Return of Test Article 
All damaged lenses, explanted lenses, unused lenses, or lenses that meet device deficiency 
criteria must be packaged in a biohazard bag and returned to the Sponsor with the appropriate 
return forms. Refer to Section 13 for additional information on reporting any device 
deficiencies and associated adverse events. 
 

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12 CLINICAL STUDY PROCEDURES 
12.1 Clinical Study Assessments 
The following section outlines the assessments to be performed in this clinical study. It is 
recommended that ocular assessments be performed in the order presented below. All 
assessments must be recorded in the source documentation, and also in the eCRF, if 
applicable. 
Assessments are described in detail in the ILR431b-P001 Manual of Procedures (hereto 
referred to as the MOP), and are outlined in tabular format in Section 6 of this protocol. 
12.1.1 Screening/Pre-surgery Visit (Visit 0) 
Below is a list of study procedures to be undertaken at Visit 0, which must take place within 
40 days prior to the date of 1st eye surgery or within 60 days prior to the date of 2nd eye 
surgery. Screen each eye that is planned to be included in the study. 
Note: Procedures that are completed as part of standard of care for routine cataract evaluation 
prior to study consent may be used if performed per protocol and within the required window. 
1. Upon identification of a potential study participant, carry out the informed consent 
process. Refer to Section 16.2 Informed Consent Procedures. 
NOTE: Subjects must formally consent to participate in the study before 
undergoing any study specific testing. 
2. Document demographics, ocular and nonocular medical history, and concomitant 
medications 
3. Collect subject reported symptoms 
4. Obtain subject Best Corrected Visual Acuity (BCVA)  
5. Assess intraocular pressure (IOP) 
6. Conduct a slit-lamp examination (refer to the MOP for grading scales). Assess the 
following: 
• Aqueous cell  
• Aqueous flare  
• Corneal edema  
• Corneal haze 

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• Fibrin in the anterior chamber or on the surface of the iris  
• Eyelid edema 
• Conjunctival hyperemia 
• Ciliary flush 
• Corneal precipitates 
• Hypopyon 
7. Conduct a dilated fundus exam (see MOP for details) ensuring grading of: 
• Vitreous cells 
• Vitreous haze 
8. Verify eligibility per the study inclusion/exclusion criteria 
9. Assess for adverse events 
 
Following confirmation of eligibility per the study inclusion/exclusion criteria, subjects will 
be scheduled for surgery (Visit 00/Visit 00A) within the required window of screening 
(Visit 0). Ineligible subjects must be exited from the study. The reason for exit must be 
documented for each subject. Refer to Section 12.4 for further detail. 
12.1.2 Surgery Visit (Visit 00/Visit 00A) 
Surgery will take place after the subject successfully completes all screening assessments and 
is confirmed eligible to participate in the study per inclusion/exclusion requirements, but not 
more than 40 days for the 1st eye (or 60 days for the 2nd eye) after the date of the 
screening/pre-surgery visit (Visit 0). Only qualified surgeons listed on the study delegation 
log (maximum of 4 per site) can perform the surgery on a study patient. The following study 
procedures must be performed at the Surgery Visit: 
1. Review and document any changes in medical history since the last visit 
2. Review and document concomitant medications 
3. Verify eligibility to continue participation per the study inclusion/exclusion criteria 
4. Perform cataract surgery and implantation of the ACRYSOF IQ RESTOR IOL per 
routine standard of care (RESTOR Toric +3.0 or RESTOR +2.5 provided by the 
Sponsor for Cohort 2) 

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5. Document any problems during surgery, as applicable 
6. Assess for adverse events and device deficiencies 
 
Note: If subject is having surgery in the second eye also, some visit windows may overlap if 
the surgery occurs within 7 days to 30 days after surgery in the first eye. 
The visit schedule for the first and second implant can be found in Table 9-1. 
12.1.3 Postoperative Visits 
Postoperative visits are to take place as follows: 
• Visit 1 and Visit 1A: Day 1-2 post-surgery 
• Visit 2 and Visit 2A: Day 7-14 post-surgery 
• Visit 3 and Visit 3A: Day 30-60 post-surgery 
• Visit 4 and Visit 4A: Day 90-180 post-surgery/Early Exit/Exit  
The following study procedures must be performed at each postoperative visit: 
1. Review and document any changes in medical history since the last visit 
2. Review and document concomitant medications 
3. Collect subject reported symptoms 
4. Obtain subject Best Corrected Visual Acuity (BCVA) 
5. Assess IOP 
6. Conduct a slit-lamp examination (refer to the MOP for grading scales). Assess the 
following: 
a. Aqueous cell  
b. Aqueous flare  
c. Corneal edema  
d. Corneal haze 
e. Fibrin in the anterior chamber, on the surface of the iris or on the IOL 
f. Eyelid edema 
g. Conjunctival hyperemia 
h. Ciliary flush 

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i. Corneal precipitates 
j. Hypopyon 
Note: For cases of exacerbated post-surgical intraocular inflammation, 
additional testing is required: 
• Dilated fundus examination with vitreous haze grading and vitreous cell 
grading 
• Photo documentation, anterior and posterior(if applicable) – see MOP for 
details on which visits testing is required  
• Culture of ocular media, required if infection suspected - see MOP for details 
on when testing is required 
7. Assess for adverse events and device deficiencies 
 
12.2 Unscheduled Visits 
An unscheduled visit (UNSV) is defined as follows: 
• Ocular examination that is not standard of care and not required by the protocol; 
• Examination conducted by the study staff; 
• New findings, or a change to a previous finding was discovered; and 
• Not site standard of care/routine 
An UNSV may or may not result in the capture of an adverse event. Likewise an adverse 
event may be captured without the report of an UNSV (eg, AE identified subsequent to study 
eye examination by non-study personnel). 
The assessments captured at the UNSV are dictated by the Investigator per his/her medical 
judgement. The following assessments are recommended: 
• Review and document any changes in medical history since the last visit 
• Review and document concomitant medications 
• Collect subject reported symptoms 
• Obtain subject BCVA 
• Assess IOP 

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• Conduct a slit-lamp examination (refer to the MOP for grading scales). Assess the 
following: 
o Aqueous cell 
o Aqueous flare  
o Corneal edema  
o Corneal haze 
o Fibrin in the anterior chamber, on the surface of the iris or on the IOL 
o Eyelid edema 
o Conjunctival hyperemia 
o Ciliary flush 
o Corneal precipitates 
o Hypopyon 
Note: For cases of exacerbated post-surgical intraocular inflammation, additional 
testing is required: 
o Dilated fundus examination with vitreous haze grading and vitreous cell 
grading 
o Photo documentation, anterior and posterior(if applicable) – see MOP for 
details on which visits testing is required  
o Culture of ocular media, required if infection suspected - see MOP for 
details on when testing is required 
• Assess for adverse events and device deficiencies 
Assessments and documentation are not limited to the above list. For safety purposes, if an 
unscheduled visit is required after the final study visit, document the visit.  
12.3 Missed Visits 
If a subject misses a scheduled visit, reschedule the subject within the same visit period. The 
Investigator must show diligence in trying to schedule the subject for all study visits, and 
document all attempts to contact the subject. In documentation, include the date, time, 
method of contact, etc.  
If a subject is unable to return for the final study visit, complete the Exit eCRF with the 
appropriate reason for discontinuation. If attempts to contact the subject are unsuccessful, 
document the date the subject is considered lost to follow-up. Complete the subjects Exit 

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eCRF after the last window (Visit 4/Visit 4A) closes, indicating the subject is lost to 
follow-up. 
12.4 Discontinued Subjects 
Subjects may be discontinued (exited) from the study early due to: 
• Failure to meet protocol eligibility criteria prior to surgery 
• Adverse event(s) 
• Administrative reasons (eg, voluntary withdrawal, lost to follow-up) 
Subjects who fail to meet protocol eligibility criteria prior to the investigational product 
touching the eye will not be followed beyond the date of determination of ineligibility. 
Implanted subjects and subjects with failed implantation (inability to successfully insert the 
study IOL) will be followed until the planned end of the study period. 
Discontinued subjects who have been implanted or in whom implantation failed will not be 
replaced. Notification of a subject’s early discontinuation should be made immediately to the 
Sponsor and documented on the appropriate eCRF. 
If a subject exits the study before completion of the final, planned study visit 
(Visit 4/Visit 4A), the Investigator should make reasonable attempts to have the subject return 
to the site to perform early exit procedures. Early exit procedures are all study procedures to 
be conducted at Visit 4/Visit 4A (see Section 12.1.3). 
12.5 Clinical Study Termination 
The Sponsor reserves the right to close the investigational site or terminate the study in its 
entirety at any time, for reasonable cause. The Investigator also may terminate the study at 
his/her site for reasonable cause. Reasons for the closure of an investigational site or 
termination of the study may include: 
• The Investigator fails to comply with the protocol or GCP guidelines 
• Safety concerns 
• Inadequate recruitment of subjects by the Investigator 
If the clinical study is prematurely terminated or suspended, the Sponsor will inform the 
Investigator and the regulatory authorities (where applicable) of the termination/suspension, 
and the reason for the termination/suspension. The Investigator should promptly notify the 
IRB of the termination or suspension and the reasons. 

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If the Sponsor terminates the study for safety reasons, it will immediately notify the 
Investigator(s), and provide written instructions for study termination and applicable subject 
follow-up. 

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13 DEVICE DEFICIENCIES AND ADVERSE EVENTS 
13.1 General Information 
An Adverse Event (AE) is any untoward medical occurrence in a subject who is administered 
a clinical study treatment (ie, implant with an investigational device) regardless of whether or 
not the event has a causal relationship with the treatment. An AE, therefore, can be any 
unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or 
disease temporally associated with the clinical study treatment, whether or not related to the 
treatment. Below are Figures that categorize AEs and SAEs. 
Figure 13–1 
Categorization of All Adverse Events 
 
Figure 13–2 
Categorization of All Serious Adverse Events 
 
ALL AEs
Device/
procedure-
related?
NO
AE
NO
SAE
ADE
YES
Meet 
seriousness 
criteria?
YES
Device/
procedure-
related?
SADE
YES
Anticipated?
Unanticipated 
SADE
NO
Anticipated 
SADE
YES
ALL SAEs
NO
SAE

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Serious Adverse Events 
A serious adverse event is an AE that led to any of the following:  
• Death 
• A serious deterioration in the health of the subject that either resulted in: 
a) a life-threatening illness or injury.  
Note: Life-threatening means that the individual was at immediate risk of 
death from the event as it occurred, ie, it does not include an event which 
hypothetically might have caused death had it occurred in a more severe 
form. 
b) any potentially sight-threatening event or permanent impairment to a body 
structure or a body function.  
c) in-patient hospitalization or prolonged hospitalization.  
Note: Planned hospitalization for a pre-existing condition, without serious 
deterioration in health, is not considered a SAE. In general, 
hospitalization signifies that the individual remained at the hospital or 
emergency ward for observation and/or treatment (usually involving an 
overnight stay) that would not have been appropriate in the physician's 
office or an out-patient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs hospitalization or 
fulfills any other serious criteria, the event is serious. When in doubt as to 
whether “hospitalization” occurred, the event should be considered 
serious. 
d) a medical or surgical intervention to prevent a) or b) or any ocular 
secondary surgical intervention (excluding posterior capsulotomy). 
e) any indirect harm as a consequence of incorrect diagnostic test results 
when used within manufacturer’s instructions for use. 
• Fetal distress, fetal death, or a congenital abnormality or birth defect. 
Any other potentially sight-threatening events may also be considered serious based upon the 
judgment of the Investigator and should be reported appropriately as delineated in 
Section 13.3. 

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Adverse Device Effect 
An adverse device effect (ADE) is an AE related to the use of an investigational product (test 
article). This definition includes AEs resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or operation; any malfunction; and use error or 
intentional misuse of the test article.  
Serious Adverse Device Effect  
A serious adverse device effect (SADE) is an ADE that has resulted in any of the 
consequences characteristic of a SAE. 
Anticipated Serious Adverse Device Effect 
An anticipated serious adverse device effect (ASADE) is a SADE which by its nature, 
incidence, severity, or outcome has been identified in the risk analysis report. 
Unanticipated Serious Adverse Device Effect 
An unanticipated serious adverse device effect (USADE) is a SADE which by its nature, 
incidence, severity or outcome has not been identified in the risk analysis report. 
Device Deficiencies 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety, or performance. This definition includes malfunctions, use 
errors, and inadequate labeling. Malfunction is defined as a failure of a medical device to 
perform in accordance with its intended purpose when used in accordance with the 
instructions for use or clinical investigation plan. Use error is defined as an act or omission of 
an act that results in a different medical device response than intended by manufacturer or 
expected by user; this includes slips, lapses, and mistakes. An unexpected physiological 
response of the subject does not in itself constitute a use error. 
A device deficiency may or may not be associated with patient harm (ie, ADE or SADE); 
however, not all ADEs or SADEs are due to a device deficiency. The Investigator should 
determine the applicable category for the identified or suspect device deficiency and report 
any patient harm separately. Examples of device deficiencies include the following: 
• Failure to meet product specifications (eg, incorrect IOL power) 
• IOL defect 
• Broken IOL optic 

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• Broken IOL haptic  
• Scratched IOL optic 
• Unsealed device packaging 
• Suspect IOL contamination   
• Lack of efficacy 
Return any IOL associated with a device deficiency to the Study Sponsor. Refer to the MOP 
for information on return of study IOLs. 
13.2 Specific Events Relevant to this Protocol 
In addition to reporting all AEs meeting the above definitions, the Investigator must report 
the following AEs:  
Exacerbated intraocular inflammation as indicated by: 
• ≥ 3+ aqueous cell within the first 14 days post-op (collected on Visit 1 or 2 or at an 
unscheduled visit between Visit 00 and Visit 2), and/or 
• ≥ 2+ aqueous cell ˃ 14 days and ≤ 60 days post-op (collected on Visit 3 or at an 
unscheduled visit between Visit 2 and Visit 3), and/or 
• ≥ 1+ aqueous cell ˃ 60 days post-op or later (collected on Visit 4 or at an unscheduled 
visit between Visit 3 and Visit 4).  
Note: Cases of exacerbated intraocular inflammation should be categorized by the 
Investigator according to Section 8.4.2. 
Subject reported symptoms should be assessed to determine if they meet the definition of an 
AE per Section 13.1 of the protocol. Symptoms associated with an AE should be captured as 
part of the AE in the narrative as appropriate. 
13.3 Procedures for Recording and Reporting 
All AEs will be documented on the Adverse Event case report form (CRF) and collected on a 
routine basis at monitoring visits. Surgically-related postoperative conditions that are normal 
consequences of the ocular surgery and not clinically relevant will only be reported as 
adverse events at the discretion of the Investigator.  
In addition, the Investigator must document all ADEs, SAEs, and device deficiencies with 
details including the date of occurrence, severity, treatment (if applicable), outcome, and 
assessments of the seriousness and causality. All available information must be submitted to 

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the study Sponsor immediately (ie, within 24 hours of the Investigator’s or site’s knowledge 
of the event) as follows: 
• ADEs, SAEs, or device deficiencies must be entered immediately into the EDC 
system. 
• Additional relevant information after initial reporting should be updated in the 
EDC system as soon as it becomes available. 
Study Sponsor contact information is provided in the Manual of Procedures (MOP).  
Further, depending upon the nature of the AE or device deficiency being reported, the study 
Sponsor may request copies of applicable portions of the subject’s medical records. The 
Investigator must also report all AEs and device deficiencies that could have led to a SADE 
according to the requirements of regulatory authorities or IRB/IEC. 
Intensity and Causality Assessments 
For every AE and device deficiency, the Investigator must assess the causality as Related or 
Not Related to the medical device or test procedure in the study. An assessment of causality 
will also be performed by a study Sponsor physician utilizing the same definitions, as shown 
below: 
Causality 
Related 
An AE or device deficiency classified as related may be either definitely 
related or possibly related where a direct cause and effect relationship with the 
medical device or test procedure has not been demonstrated, but there is a 
reasonable possibility that the AE or device deficiency was caused by the 
medical device or test procedure. 
Not Related 
An AE or device deficiency classified as not related may either be definitely 
unrelated or simply unlikely to be related (ie, there are other more likely 
causes for the AE or device deficiency). 
Where appropriate, the Investigator must assess the intensity (severity) of the AE as mild, 
moderate, or severe, based upon medical judgment with consideration of any subjective 
symptom(s), as defined below:  

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Intensity (Severity) 
Mild 
An AE is mild if the subject is aware of but can easily tolerate the sign or 
symptom. 
Moderate 
An AE is moderate if the sign or symptom results in discomfort significant 
enough to cause interference with the subject’s usual activities. 
Severe 
An AE is severe if the sign or symptom is incapacitating and results in the 
subject’s inability to work or engage in their usual activities. 
The Investigator must document any action taken (ie, medication, intervention, or treatment 
plan) and outcome of the AE or device deficiency when applicable. 
13.4 Unmasking of the Study Information 
Not applicable; this study is open-label. 
13.5 Follow-Up of Safety Information 
The Investigator is responsible for adequate and safe medical care of subjects during the 
study and for ensuring that appropriate medical care and relevant follow-up procedures are 
maintained after the study. Any additional data from these follow-up procedures must be 
documented and available upon the study Sponsor’s request.  
 

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14 DATA REVIEW AND HANDLING 
14.1 Completion of Source Documents and Case Report Forms 
The nature and location of all source documents must be identified to ensure that original 
data required to complete the eCRFs exist and are accessible for verification by the monitor. 
Data reported on the eCRFs must be derived from source documentation, be consistent with 
source documentation, and any discrepancies must be explained in writing. At a minimum, 
source documentation must include the following information for each subject: 
• Subject identification (name, sex) 
• Documentation of subject eligibility 
• Date of informed consent, and a copy of the signed consent form 
• Dates of visits 
• Documentation that protocol-specific procedures were performed 
• Results of study assessment, as required by the protocol 
• Documentation of AEs and other safety parameters (as applicable) 
• Records regarding medical histories and the use of concomitant therapies prior to and 
during the study 
• Date of study completion and reason for early discontinuation (if applicable) 
It is required that the author of each entry in the source documents be identifiable (eg, initials 
or signature and date). Any change or correction to data reported in the source, or on an 
eCRF, must be dated, initialed, and explained if necessary. Changes must not obscure the 
original entry (ie, an audit trail must be maintained). Direct access to source documentation 
(medical records) must be allowed for the purpose of verifying that the data recorded on the 
eCRF are consistent with the original source data. 
EDC is designated for data collection and should be completed by designated individuals 
only. Required examinations must be recorded in the eCRFs. All data reported must have 
corresponding entries in the source documents. The Investigator will review the reported data 
and certify that the eCRFs are accurate and complete as indicated by signature. Subject 
identifiers must not be recorded on the eCRFs beyond subject number, demographics 
information, and/or other study identifiers. 
Deviations from this protocol, regulatory requirements, and Good Clinical Practice (GCP) 
must be recorded in the study records. An explanation of the deviation should be included, as 

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applicable. In addition, corrective and preventative action should be identified, implemented 
and documented within the study records. 
14.2 Data Review and Clarifications 
Upon completion of the eCRFs, targeted data will be reviewed by the assigned Sponsor 
global clinical site management (CSM), or designee, team for accuracy and completeness. 
The planned source document verification and overall monitoring activities for this study are 
outlined in a separate document, the Protocol Monitoring Plan. Corrections and/or any 
necessary additions to the data will be applied and if required, queries will be generated. 
Designated investigative staff are expected to respond to data queries in a timely manner and 
ensure that the corrections and changes made to the data are reflected in the subjects’ source 
documentation. Deviations from this protocol, regulatory requirements and GCP must be 
recorded. An explanation of the deviation should be included, as applicable. In addition, 
corrective and preventive action should be identified, implemented and documented within 
the study records. Prior to study start, a plan for data validation will be completed by Alcon 
clinical data management (or designee), and agreed upon by the study clinical manager (CM) 
and other team members. 
Medical history and adverse events will be coded using the medical dictionary for regulatory 
activities (MedDRA) terminology. Upon completion of the study and once the database is 
declared completed and accurate, the database will be locked and data will be available for 
data analysis. Any changes to the database after lock will be implemented upon agreement 
between the Sponsor’s clinical study management, medical safety clinical data management 
and biostatistics departments, and will be completed following the Sponsor’s procedures for 
changes to a database after database lock. 

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15 ANALYSIS PLAN 
15.1 Subject Evaluability 
Subject evaluability will be determined prior to locking the database for each cohort 
accordingly, based upon the Deviations and Evaluability Plan (DEP). 
15.2 Analysis Data Sets 
The safety set includes all eyes with attempted test article implantation (successful or aborted 
after contact with the eye). The safety set will be used for all safety analyses 
 
Modified safety set 
includes all eyes with successful test article implantation. The modified safety set will be 
used for a sensitivity analysis of the primary safety endpoint. Second eye surgery within 6 
months of the occurrence of first cataract surgery will be included in the primary analysis. If 
both eyes of a subject are enrolled in this study, full follow-up information from both eyes 
will be used in the primary analysis. 
The above definition applies to both Cohort 1 and Cohort 2. Unless otherwise specified, 
analyses described below will be reported only for Cohort 2.  
15.3 Demographics and Baseline Characteristics 
Summary statistics will be provided for demographic and baseline characteristics for each 
cohort. Number and percentage will be presented for categorical variables and descriptive 
statistics including mean, standard deviation, median, minimum and maximum will be 
presented for continuous variables.  
15.4 Performance Analyses 
Not applicable. This is a post-approval safety study of the ACRYSOF IQ RESTOR Toric 
IOL. 
15.4.1 Primary Performance 
Not applicable. 
15.4.1.1 Statistical Hypotheses 
Not applicable. 

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15.4.1.2 Analysis Methods 
Not applicable. 
15.4.2 Secondary Performance 
Not applicable. 
15.4.2.1 Statistical Hypotheses 
Not applicable. 
15.4.2.2 Analysis Methods 
Not applicable. 
15.4.3 Supportive Performance 
Not applicable. 
15.4.3.1 Statistical Hypotheses and Model 
Not applicable. 
15.4.3.2 Analysis Methods 
Not applicable. 
15.5 Handling of Missing Data 
The safety set does not include any imputed values for missing data. 
15.6 Multiplicity 
Not applicable. This is a post-approval safety study of the ACRYSOF IQ RESTOR Toric 
IOL. 
15.7 Safety Analysis 
For primary safety, the rate of post-surgical intraocular inflammation (based upon the 
specified case definition) reported within a 180-day post-surgical period following 
implantation of study IOLs (Cohort 2) in the United States will be estimated along with the 
exact two-sided 95% confidence interval. The event rate (per 1,000 IOL implants) is 
calculated as: 

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Total # of reported events/Total # of implants x 1,000 
A subgroup analysis on the primary safety endpoint will be performed by age groups 
(22-64 years vs. 65 years or older). If both eyes of a subject are enrolled in this study, full 
follow-up information for both eyes will be used in the primary analysis. As sensitivity 
analyses, two cumulative event rates at 180 days and the corresponding two-sided 95% 
confidence interval will be provided using Kaplan-Meier estimator: 
• Full follow-up information for both eyes is used 
• If a subject has a second cataract surgery within 180 days of the occurrence of the first 
cataract surgery, the follow-up for the first eye will be censored at the time of second 
surgery 
For secondary safety, the rates of Toxic Anterior Segment Syndrome, acute postoperative 
endophthalmitis, chronic postoperative endophthalmitis, and uncategorized cases of post-
surgical intraocular inflammation (based upon the specified case definition) reported within a 
180-day post-surgical period following implantation of study IOLs (Cohort 2) in the United 
States will be estimated along with the exact two-sided 95% confidence interval. 
 
 
 
 
 
Adverse Events 
All information obtained on adverse events will be displayed by subject and eye. 
The number and percentage of all ocular adverse events, including secondary surgical 
interventions (SSIs) for either eye, will be tabulated by preferred term with a breakdown by 
implanted eye and overall. An eye with multiple ocular adverse events of the same preferred 
term is only counted once toward the total of this preferred term. 
Nonocular adverse events will be tabulated by preferred term. 
Device Deficiencies 
The number and percentage of all device deficiencies will be tabulated with a breakdown by 
implanted eye and overall. A listing of all device deficiencies will also be provided. 

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Other Safety Assessments 
All other safety assessments (including surgical problems, slit-lamp examination, post-
surgical anterior segment inflammation, aqueous cell, aqueous flare, hypopyon, corneal 
edema, corneal haze, fibrin in the anterior chamber, fibrin on the surface of the iris, fibrin on 
the intraocular lens, dilated fundus exam, inflammatory cells or haze in the vitreous, subject 
reported symptoms, and best corrected visual acuity) will be summarized. Summaries of 
continuous variables will include the number of observations, mean, standard deviation, 
median, minimum and maximum. Summaries of categorical variables will include the 
number of eyes with data for the variable, as well as the number and percentage of eyes in 
each category for the variable. 
15.8 Interim Analyses 
Interim reports pertaining to the progress of this study will be submitted to the FDA for 
review every six months up to the first two years, or as requested, starting from the date of 
approval of the ACRYSOF IQ RESTOR Toric IOLs, and will continue to be submitted 
annually thereafter until study completion. 
For each interim report, the number of eyes enrolled, the number of eyes with an attempted 
implantation and the number of eyes with implantation of the ACRYSOF IQ RESTOR study 
IOLs will be reported. In addition, the rates for post-surgical intraocular inflammation, Toxic 
Anterior Segment Syndrome, acute postoperative endophthalmitis, chronic postoperative 
endophthalmitis, and uncategorized cases of post-surgical intraocular inflammation will be 
reported, and a listing of all such events will be provided. A listing of all ocular SAEs will 
also be provided. 
15.9 Adaptive Study Design 
Not applicable. 
15.10 Sample Size Justification 
The precision of the estimated rate can be assessed using the width of an exact two-sided 
95% confidence interval. In Figure 15-1, the exact two-sided 95% confidence intervals with a 
sample size (N) of 3,000 are shown when the observed rate ranges from 1 to 10 (per 1,000). 
As an example, with N = 3,000, the width of the exact two-sided 95% confidence will be 
3.6 (per 1,000) when the observed rate is 2 (per 1,000). 

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Figure 15–1 
The exact two-sided 95% confidence intervals with N = 3,000 when 
the observed rate ranges from 1 to 10 (per 1,000) 
 

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16 ADMINISTRATIVE PROCEDURES 
16.1 Regulatory and Ethical Compliance 
This clinical study will be conducted in accordance with the principles of the Declaration of 
Helsinki, and in compliance with ISO 14155:2011 Clinical investigation of medical devices 
for human subjects – Good clinical practice, Code of Federal Regulations (CFR), Standard 
Operating Procedures (SOPs) of Alcon and Contract Research Organizations participating in 
the conduct of the clinical study, and all other applicable regulations. The Investigator and all 
clinical study staff will conduct the clinical study in compliance with this protocol. The 
Investigator will ensure that all personnel involved in the conduct of the clinical study are 
qualified to perform their assigned duties through relevant education, training, and 
experience.  
The Study Sponsor assures that the key design elements of this protocol will be registered on 
www.clinicaltrials.gov as required by current regulations. In addition, results of this study 
will be made publicly available on www.clinicaltrials.gov regardless of outcome as required 
by current regulations as applicable. 
16.2 Informed Consent Procedures 
Voluntary informed consent will be obtained from every subject (and/or legal representative, 
as applicable) prior to the initiation of any screening or other clinical study-related 
procedures. The Investigator must have a defined process for obtaining consent. Specifically, 
the Investigator, or designee, will explain the clinical study to each potential subject and the 
subject must indicate voluntary consent by signing and dating the approved informed consent 
form. The subject must be provided an opportunity to ask questions of the Investigator, and if 
required by local regulation, other qualified personnel. The Investigator must provide the 
subject with a copy of the consent form written in a language the subject understands. The 
consent document must meet all applicable local laws and will provide subjects with 
information regarding the purpose, procedures, requirements, and restrictions of the clinical 
study, along with any known risks and potential benefits associated with the investigational 
product, the available compensation, and the established provisions for maintaining 
confidentiality of personal, protected health information. Subjects will be told about the 
voluntary nature of participation in the clinical study and will be provided with contact 
information for the appropriate individuals should questions or concerns arise during the 
clinical study. The subject also will be told that their records may be accessed by appropriate 
authorities and Sponsor-designated personnel. The Investigator must keep the original, signed 
copy of the consent and must provide a duplicate copy to each subject. 

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16.3 Responsibilities of the Investigator and IRB 
Before clinical study initiation, this protocol, the informed consent form (and assent form, if 
applicable), any other written information provided to subject, and any advertisements 
planned for subject recruitment must be approved by an Institutional Review Board (IRB). 
Documentation for IRBs for this clinical study can be found in the Trial Master File. The 
Investigator must provide documentation of IRB approval to the Sponsor. The approval must 
be dated and must identify the applicable protocol, amendments (if any), informed consent 
form, assent form (if any), all applicable recruiting materials, written information for 
subjects, and subject compensation programs. The IRB must be provided with a copy of the 
Package Insert, any periodic safety updates, and all other information as required by local 
regulation and/or the IRB. At the end of the clinical study or in the case of early termination, 
the Investigator will notify the IRB of the clinical study’s final status. Finally, the 
Investigator will report to the IRB on the progress of the clinical study at intervals stipulated 
by the IRB. 
16.4 Sponsor and Monitoring Responsibilities 
The Sponsor will designate a monitor to conduct the appropriate site visits at the appropriate 
intervals. The clinical investigation will be monitored to ensure that the rights and wellbeing 
of the subjects are protected; the reported data are accurate, complete and verifiable from the 
source documents, the equipment used to assess variables in the clinical investigation is 
maintained and calibrated per manufacturer instructions and Sponsor requirements; and the 
study is conducted in compliance with the current approved protocol (and amendment[s], if 
applicable), with current GCP, and with applicable regulatory requirements. 
All investigative sites will have a site initiation. Monitoring will be conducted periodically 
while the clinical study is ongoing. Monitoring methods may include site visits, telephone, 
written, and fax correspondence. The assigned monitor will contact each site at appropriate 
intervals. The Lead Clinical Site Manager (LCSM) will determine the frequency of site visits. 
Close-out visits will take place after the last visit of the last subject. 
Enrollment will be tracked and reported at regular intervals. Details regarding enrollment (eg, 
number of subjects pre-screened, screened, reasons for screen failures) may be requested of 
the investigative site and must be provided within a reasonable time period. 
The Sponsor will be responsible for implementing and maintaining quality assurance and 
quality control systems to ensure the study is conducted and data are generated, documented 
and reported in compliance with the protocol, GCP and applicable regulatory requirements. 
The Sponsor will secure agreement from all involved parties to ensure direct access to all 
study related sites, source data and documents, and reports for the purpose of monitoring and 

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auditing by the Sponsor, and inspection by regulatory authorities. Quality control will be 
applied to each stage of data handling to ensure that all data are reliable and have been 
processed correctly.  
16.5 Subject Confidentiality 
The Investigator must ensure that the subject’s anonymity is maintained throughout the 
course of the study. In particular, the Investigator must keep an enrollment log with 
confidential identifying information that corresponds to the subject numbers and initials of 
each study participant. At the end of the clinical study, the Study Sponsor will collect a copy 
of the enrollment log without any identifying subject information. All documents submitted 
to the Study Sponsor will identify the subjects exclusively by number and demographic 
information. No other personally identifying information will be transmitted to the Study 
Sponsor. 
The Study Sponsor may release anonymized study data to external researchers for purposes 
of future research directly related to the study objectives, or future research that is beyond the 
scope of the current study objectives. The Informed Consent Form explains this to study 
subjects. Anonymization means that all identifiable information will be removed from the 
dataset and all links to the subjects in the study will be removed. Anonymization of the data 
will maintain confidentiality of the subjects who participate in the study so that they cannot 
be identified by external researchers. The anonymized data set will contain records from all 
of the subjects in the current study, but the anonymization process might change the data set 
in some ways, so external researchers will be informed that they might not be able to 
duplicate some of the results from this study. 
16.6 Regulatory Documentation and Records Retention 
The Investigator is accountable for the integrity, retention and security of all study-related 
data. The Investigator must maintain accurate, complete, and current records relating to the 
clinical study. The Investigator must maintain the required records during the clinical study 
and for a period of time specified by local law or per the Clinical Study Agreement, 
whichever is longer. If the Investigator retires, relocates, or for any other reason withdraws 
from responsibility of keeping the study records, the Sponsor must be notified and suitable 
arrangements made for retention of study records and source documents needed to comply 
with national and international regulations. 

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16.7 Clinical Study Results  
The Investigator will notify the accredited IRB at the end of the study as required by the IRB. 
The end of the study is defined as database lock. In the case the study is ended prematurely, 
the Investigator will notify the accredited IRB, including the reasons for premature 
termination. Within one year after the end of the study, the Investigator/Sponsor will submit a 
final study report with the results of the study, including any publications/abstracts of the 
study, to the accredited IRB as required. 
16.8 Publication of the Clinical Study 
Any study information should not be discussed with persons outside of the clinical study. The 
protocol, study data, and information related to the study or to Alcon’s products or research 
programs that is provided by Alcon (Confidential Information) is to be kept confidential, and 
not disclosed directly or indirectly to any third party other than those involved in the study 
who have a need to know. 
All data and discoveries arising out of the study, patentable or non-patentable, shall be the 
sole property of Alcon. Alcon reserves the right of prior review of any publication or 
presentation of information related to the study. Alcon may use these data now and in the 
future for presentation or publication at Alcon’s discretion or for submission to government 
regulatory agencies. 
The existence of this clinical study is confidential and should not be discussed with persons 
outside of the study. You shall hold confidential, and not disclose directly or indirectly to any 
third party other than those persons involved in the study who have a need to know, the 
protocol, the data arising out of the study, and any other information related to the study or to 
Alcon’s products or a research program that is provided by Alcon to you (the “Confidential 
Information”). All such persons must be instructed not to further disseminate this information 
to others. You shall not use the Confidential Information for any purpose other than the study. 
The foregoing obligations of confidence and non-use assumed by you shall not apply to: 
(a)information which at the time of disclosure is in the public domain; (b) information which 
thereafter lawfully becomes part of the public domain other than through disclosure by or 
through you; (c) information which, as evidenced by your written records, was known by you 
prior to Alcon’s disclosure; (d) information which is lawfully disclosed to you by a third 
party not under any obligation of confidence to Alcon; or (e) information which is required to 
be disclosed by law or government regulatory agency, provided reasonable advance notice of 
such disclosure is given to Alcon. 

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In signing this protocol, you agree to the release of the data from this study and acknowledge 
the above confidentiality and publication policy. The provisions of this Statement shall 
survive completion of the study. 

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18 APPENDICES 
Appendix A: Directions for Use for ACRYSOF IQ RESTOR +3.0 D 
Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) 
 

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Appendix B: Directions for Use for ACRYSOF IQ RESTOR +2.5 D 
Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) 

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Approved Date: 02 Sep 2020 
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Status: Approved, Version: 10.0 
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Status: Approved, Version: 10.0 
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Status: Approved, Version: 10.0 
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Status: Approved, Version: 10.0 
Approved Date: 02 Sep 2020 
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Status: Approved, Version: 10.0 
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Status: Approved, Version: 10.0 
Approved Date: 02 Sep 2020 
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Status: Approved, Version: 10.0 
Approved Date: 02 Sep 2020 
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Status: Approved, Version: 10.0 
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Status: Approved, Version: 10.0 
Approved Date: 02 Sep 2020 
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Status: Approved, Version: 10.0 
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Approved Date: 02 Sep 2020 
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Appendix C: Directions for Use for ACRYSOF IQ RESTOR +2.5 D 
Multifocal IOL (Model SV25T0) 
 
 
 
 
 
 

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Approved Date: 02 Sep 2020 
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