Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600
Phase: NA
Conditions: Cataract, Astigmatism
Sponsor: Abbott Medical Optics

 
 
Study Protocol 
 
 
POST–APPROVAL STUDY OF THE TECNIS® 
TORIC IOL EXTENDED CYLINDER RANGE (ECR), 
MODELS ZCT450, ZCT525 AND ZCT600 
 
 
NCT Number: NCT02649842  
Document date: 17 Feb 2017 
 
 
 
 
 
 

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CONFIDENTIAL 
The following contains confidential, proprietary information  
that is the property of Abbott Medical Optics Inc. 
 
POST–APPROVAL STUDY OF THE TECNIS® TORIC IOL EXTENDED CYLINDER 
RANGE (ECR), MODELS ZCT450, ZCT525 AND ZCT600 
 
PROTOCOL NUMBER:  TIOL-204-EPAS 
 
SPONSOR:  Abbott Medical Optics Inc. 
1700 E. St. Andrew Place 
Santa Ana, CA 92705 
714-247-8200 
 
Investigator Agreement 
 
As an Investigator, I agree to: 
• Implement and conduct this study diligently and in strict compliance with this 
agreement; the protocol; Good Clinical Practices; 21CFR812, ISO 14155 and all 
other applicable FDA regulations; conditions of approval imposed by the 
reviewing Institutional Review Board (IRB), FDA or other regulatory authorities; 
and all other applicable laws and regulations. 
• Supervise all testing of the device where human subjects are involved. 
• Ensure that the requirements for obtaining informed consent are met. 
• Obtain authorization for use/disclosure of health information (e.g., HIPAA 
authorization or equivalent). 
• Maintain all information supplied by Abbott Medical Optics in confidence and, 
when this information is submitted to an independent IRB or any other group, it 
will be submitted with a designation that the material is confidential. 
 
I have read this protocol in its entirety and I agree to all aspects. 
 
 
   
   
 
Investigator Printed Name 
Signature 
Date 
 
 
   
   
 
Subinvestigator Printed Name 
Signature 
Date 
 
 
Acknowledged By: 
 
   
   
 
Signature of Sponsor’s Representative 
Date 
_________________________________________________________________ 
Printed Name and Title 
 

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TABLE OF CONTENTS 
TITLE 
PAGE 
Table of Contents 
.......................................................................................................... 2 
Personnel and Facilities................................................................................................ 4 
PROTOCOL CHANGE HISTORY 
................................................................................... 5 
1. 
Synopsis 
............................................................................................................. 6 
2. 
Background/Introduction ................................................................................ 
10 
3. 
Clinical Hypothesis 
.......................................................................................... 
11 
4. 
Study Design 
.................................................................................................... 
11 
5. 
Acronyms 
......................................................................................................... 
11 
6. 
Study Objectives and Endpoints .................................................................... 
11 
6.1 Primary Endpoint 
............................................................................................. 
11 
6.2 Other Endpoints 
............................................................................................... 
12 
7. 
Study Products ................................................................................................ 
12 
7.1 Intraocular Lenses 
........................................................................................... 
12 
7.2 IOL Implantation Systems 
................................................................................ 
15 
8. 
Study Population ............................................................................................. 
15 
8.1 Inclusion Criteria 
.............................................................................................. 
15 
8.2 Exclusion Criteria 
............................................................................................. 
16 
9. 
Investigator Selection 
...................................................................................... 
17 
9.1 Investigator Qualifications 
................................................................................ 
17 
9.2 Investigator Obligations 
................................................................................... 
17 
9.3 Investigator Approval 
....................................................................................... 
18 
10. 
Study Timeline ................................................................................................. 
19 
11. 
Study Plan 
........................................................................................................ 
19 
11.1 Overview ......................................................................................................... 
19 
11.2 visit Schedule .................................................................................................. 
21 
11.3 Preoperative Procedures 
................................................................................. 
21 
11.4 Study Lens Supply 
........................................................................................... 
23 
11.5 Operative Procedures 
...................................................................................... 
23 
11.6 Postoperative Procedures ............................................................................... 
24 
11.7 Unscheduled Visits 
.......................................................................................... 
26 
11.8 Exit of Subjects 
................................................................................................ 
27 
11.9 Protocol Deviations 
.......................................................................................... 
29 
12. 
Adverse Events and Product Complaints 
...................................................... 
29 
12.1 Adverse Event Definitions 
................................................................................ 
29 

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12.2 Product Complaint/Device deficiency Definition 
............................................... 
31 
12.3 Adverse Event and Complaint Reporting Requirements 
.................................. 
31 
12.4 Causal relationship 
.......................................................................................... 
32 
12.5 Adverse Event Follow-up 
................................................................................. 
33 
13. 
Protocol Changes/Amendments 
..................................................................... 
33 
14. 
Ethics Review and Patient Welfare 
................................................................. 
33 
14.1 Institutional Review Board (IRB) 
...................................................................... 
33 
14.2 Informed Consent 
............................................................................................ 
33 
15. 
Documentation 
................................................................................................. 
34 
15.1 Source Documents 
.......................................................................................... 
34 
15.2 Subject Confidentiality 
..................................................................................... 
35 
15.3 Case Report Form Completion ........................................................................ 
35 
15.4 Study Summary 
............................................................................................... 
35 
16. 
Monitoring 
........................................................................................................ 
35 
16.1 Data Monitoring 
............................................................................................... 
35 
16.2 Administrative Monitoring ................................................................................ 
36 
16.3 Medical Oversight 
............................................................................................ 
37 
17. 
Publications ..................................................................................................... 
37 
18. 
Risk Analysis ................................................................................................... 
37 
19. 
Records Retention 
........................................................................................... 
38 
20. 
Termination of the Investigation 
..................................................................... 
39 
20.1 Statistical Methods .......................................................................................... 
39 
20.2 Analysis Population ......................................................................................... 
39 
20.3 Primary endpoint ............................................................................................. 
40 
20.4 Other endpoints 
............................................................................................... 
40 
20.5 Interim Reports 
................................................................................................ 
41 
20.6 Sample Size Calculations 
................................................................................ 
41 
Appendix A   Summary of Procedures Required at Each Visit ................................ 
42 
Appendix B   Toric IOL Axis Measurement at SLIT Lamp 
......................................... 
43 
Appendix C   Slit-Lamp Exam Ratings 
....................................................................... 
44 
Appendix D   Adverse Event and Complaint Reporting Instructions 
....................... 
46 
 
 
 

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PROTOCOL CHANGE HISTORY 
Version Section(s) 
Page(s) 
Description of Change(s)  
Rationale for Change(s) 
1.0 
N/A 
N/A 
Original 
N/A 
2.0 
Personnel and Facilities 
4 
Updated name of Clinical 
Operations contact 
Personnel changes 
 
Footer 
All 
Changed to DDMMM2016/v2.0 
New version of document 
 
Table of Contents 
2 –3 
Updated contents of table  
Changes in protocol 
 
Protocol Change History 
5-6 
Added change history 
Explain why changes were made 
 
1.0 Synopsis, Overall Study Design 
 
4.0 Study Design 
 
8.0 Study Population 
 
11.1 Overview 
 
7 
 
11 
 
15 
 
20 
Updated enrollment to 120 
subjects at up to 20 sites.  
Additionally decreased the target 
site enrollment number to 6 from 
8.  
 
Removed “75” from additional 
implants.   
 
Enrollment has proven to be more difficult 
than anticipated and there is a need to add 
more sites and allow for additional 
enrollment for screen failures.  
 
 
Correction and consistency with pg. 15. 
 
 
 
8.0 Study Population 
15 
Changed wording of “implant” to 
“enroll”.    
Correction; consistency with synopsis.  
 
10.0 Study Timeline,   
           Table 3 Expected Study Timeline 
19  
Updated to reflect enrollment 
difficulty for this patient population 
Modify wording relative to clinical 
study final report 
Enrollment has been more difficult than 
anticipated.  
Edit per FDA request. 
 
10.0 Study Timeline,   
  
20.5 Interim Reports 
19 
 
41  
Correction to when PAS study 
reports will be submitted (based 
on PMA approval date, not study 
initiation) 
Correction to be in compliance with FDA 
Guidance on “Procedures for Handling Post-
Approval Studies Imposed by PMA Order” 
dated June 15, 2009 (4A).  

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1. 
SYNOPSIS 
PROTOCOL: 
Post-Approval Study of the TECNIS® Toric 1-Piece IOL 
Extended Cylinder Range, Models ZCT450, ZCT525 and 
ZCT600. 
 
Protocol: TIOL-204-EPAS 
 
STUDY TREATMENTS: 
Study Product:  TECNIS Toric 1-Piece IOLs 
 
TECNIS Toric Extended Cylinder Range Study Lenses:    
• TECNIS Toric 1-Piece IOL, Model ZCT450  
• TECNIS Toric 1-Piece IOL, Model ZCT525 
• TECNIS Toric 1-Piece IOL, Model ZCT600 
The ZCT450, ZCT525 and ZCT600 lens models 
are designed for cataract patients with 
pre-existing corneal astigmatism that, when 
surgically induced astigmatism (SIA) is taken into 
account, have approximately 3.00 D to 4.75 D of 
predicted corneal astigmatism to be corrected. 
 
Other TECNIS Toric Study Lenses:    
• TECNIS Toric 1-Piece IOL, Model ZCT300  
• TECNIS Toric 1-Piece IOL, Model ZCT375  
• TECNIS Toric 1-Piece IOL, Model ZCT400  
*The ZCT375 IOL may replace the ZCT400 IOL in this 
study following FDA-approval. 
 
Control Product:  No control product will be used in this 
study 
 
STUDY OBJECTIVE: 
The purpose of this post-approval study is to evaluate the 
rates of severe visual distortions for the TECNIS Toric 
1-Piece IOLs with Extended Cylinder Range  of 
approximately 3.00 D to 4.75 D of cylinder correction at the 
corneal plane (Models ZCT450, ZCT525 and ZCT600) in 
clinical practice to ensure continued safety of these 
FDA-approved devices. 
 
CLINICAL HYPOTHESIS: Severe visual distortions for the TECNIS Toric IOL Models 
ZCT450, ZCT525 and ZCT600 will be reported in less than 
10 percent of the study population. 
 
 

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OVERALL STUDY DESIGN: 
Structure: 
Prospective, multicenter, bilateral, non-randomized, open-
label clinical study 
 
Number of sites: 
Up to 20 sites in the USA 
 
Duration: 
6 months; however, any subjects that undergo a lens 
repositioning procedure due to IOL misalignment or that 
report a severe visual distortion at six months, will be 
followed through 1 year postoperatively.   
 
Administration: 
Surgeons will perform standardized, small-incision, 
cataract surgery and implant the study lenses using an 
AMO-validated, insertion system qualified for use with the 
study lenses.  Refractive target outcomes will be 
emmetropia for both eyes. 
 
Visit Schedule: 
All subjects will undergo a minimum of 5 visits:  
Preoperative for both eyes, Operative 1
st eye, Operative 
2nd eye, 1-month and 6-month visits for both eyes together. 
If a subject experiences a lens repositioning procedure for 
IOL misalignment or if a subject reports a severe visual 
distortion at 6 months, the subject will also undergo a final 
visit at 1 year. 
 
STUDY POPULATION CHARACTERISTICS: 
 
Condition: 
Bilateral cataracts with corneal astigmatism of 
approximately 2.00 D to 4.75 D (with 3.00 D to 4.75 D in at 
least one eye) based on the combination of preoperative 
keratometric cylinder and the expected effect of surgically-
induced astigmatism (SIA).  
 
Number of Subjects: 
Up to 120 subjects will be enrolled to achieve bilateral 
implantation in approximately 80 subjects; a minimum of 
15 subjects will be implanted with a TECNIS Toric ZCT600 
in at least one eye, and the remaining subjects will be 
implanted with either a TECNIS Toric ZCT450, ZCT525 or 
ZCT600 in at least one eye.  
 
This is a bilateral study; both eyes must be implanted with 
a TECNIS Toric IOL (ZCT300 – ZCT600); however, each 
eye may have a different TECNIS Toric IOL implanted as 
determined by the surgeon however as stated above, at 
least one eye must be implanted with a TECNIS Toric ECR 
IOL (ZCT450-ZCT600). The eye with the highest toric 
power IOL will determine the model group.   
 
Each site should enroll approximately 6 subjects and no 
site may enroll more than 20% of the enrollment total.  

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Inclusion Criteria (all criteria apply to each study eye): 
• Minimum 22 years of age 
• Bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned 
• Preoperative keratometric cylinder of at least 2.00 D in both eyes.  At least one 
eye, when taking surgically induced astigmatism into account, must have 
approximately 3.00 D to 4.75 D of predicted corneal astigmatism to be corrected 
and qualify for implantation of ZCT450, ZCT525 or ZCT600 IOLs as determined 
by the web-based AMO Toric IOL Calculator 
o Most appropriate toric IOL model choice (ZCT450, ZCT525 or ZCT600) is 
to be based on the associated residual refractive cylinder (lowest) and axis  
• Clear intraocular media other than cataract in each eye 
• Availability, willingness, ability and sufficient cognitive awareness to comply with 
examination procedures and study visits 
• Ability to understand, read and write English in order to consent to study 
participation and complete a study questionnaire 
• Signed informed consent and HIPAA authorization   
 
Exclusion Criteria (all criteria apply to each study eye): 
• Irregular corneal astigmatism 
• Any corneal pathology/abnormality other than regular corneal astigmatism 
• Previous corneal surgery 
• Recent ocular trauma or intraocular surgery that is not resolved/stable or may 
affect visual outcomes 
• Any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) 
• Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects 
• Known ocular disease or pathology that may affect visual acuity or that may 
require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.) 
• Concurrent participation or participation during 30 days prior to preoperative visit 
in any other clinical study 
• Planned monovision correction 
• Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to refractive 
changes 

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EVALUATION CRITERIA: 
The purpose of this post-approval study is to evaluate the rates of severe visual 
distortions for the TECNIS Toric 1-Piece  IOLs with Extended Cylinder Range of 
approximately 3.00 D to 4.75 D of cylinder correction at the corneal plane (Models 
ZCT450, ZCT525 and ZCT600). The primary endpoint is the rate of severe visual 
distortions reported by subjects under overall circumstances at 6 months for any of the  
5 items of interest contained in the visual distortion questionnaire (PRVDQ). Other 
endpoints are individual visual distortion ratings, mean percent reduction in absolute 
cylinder, percent of eyes with cylinder and spherical equivalent (MRSE) within 0.50 D 
and within 1.00 D of intended, mean difference between IOL axis marker location and 
postoperative steep keratometry meridian, uncorrected and best corrected distance 
visual acuity (monocular and binocular), rates of medical and/or lens findings, rates of 
IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment 
and rates of other adverse events.  
DATA ANALYSIS: 
The key timeframe for reporting results is the 6-month visit.  The rate of severe visual 
distortions is defined as the percentage of subjects who report one or more severe visual 
distortions under overall circumstances at 6 months for any of the 5 items of interest 
visual distortion items listed under the primary endpoint. The frequency, proportion and 
95% Confidence Interval (CI) of those with severe visual distortions will be reported for 
all bilateral subjects. In addition, the frequency and proportion of bilateral subjects with 
each response to individual visual distortion items from the questionnaire will also be 
reported for bilateral subjects in the overall and with and without correction 
circumstances. 
Mean percent reduction in cylinder, mean absolute cylinder, mean spherical equivalent 
and mean cylinder and spherical equivalent compared to intended values will be 
reported for primary eyes  (the eye with the higher cylinder Toric IOL) and fellow eyes.  
The frequency and proportion of eyes within 0.50 D and within 1.00 D of intended 
refractive cylinder and spherical equivalent will also be determined. The frequency and 
proportion of eyes/subjects achieving each acuity level for uncorrected and best 
corrected distance visual acuity will also be reported. 
The frequency and proportion of primary and fellow eyes with medical/lens findings or 
adverse events will also be reported.  
STUDY VISITS AND PROCEDURES: 
Inclusion and exclusion qualifications will be assessed at the preoperative visit according 
to the inclusion/exclusion criteria.  The Informed Consent Document and Authorization 

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for Use/Disclosure of Health Information form (HIPAA authorization or equivalent 
documentation necessary to comply with applicable privacy laws pertaining to medical 
treatment in the governing countries) must be signed by any patients who agree to 
participate in the study prior to undergoing any study-specific procedures.  
Each subject will have bilateral implantation of high cylinder TECNIS toric IOLs (Models 
ZCT300, ZCT375, ZCT400, ZCT450, ZCT525, ZCT600) in which at least one eye will be 
implanted with TECNIS toric IOLs Model ZCT450, ZCT525 or ZCT600.  The fellow eye 
will be implanted with the high cylinder TECNIS toric IOL Model ZCT as chosen by the 
surgeon.    
All subjects are intended to have bilateral cataract surgery with the second-eye surgery 
occurring within approximately 1 month of the first-eye surgery (≤60 days).  Two 
postoperative study visits will be conducted; at 1 month (30-60 days after the second-
eye surgery) and at 6 months (120-180 days after the second-eye surgery) for both eyes 
together.  However, subjects who underwent an IOL repositioning procedure due to IOL 
misalignment or who reported a severe visual distortion at 6 months will return for a final 
visit at 1 year (330-420 days after the second-eye surgery) postoperatively. 
2.  
BACKGROUND/INTRODUCTION 
Amongst patients undergoing cataract surgery, approximately 35-41% of cataract 
patients have ≥ 0.75 diopter of corneal astigmatism1 and about 3% have corneal 
astigmatism of  3.25 D or greater1.  Although there are various modalities to reduce the 
amount of astigmatism during cataract surgery (e.g., limbal relaxing incisions, etc.), toric 
IOLs are now commonly used for correction of aphakia and pre-existing ocular 
astigmatism.  Additionally, corneal treatments for astigmatism reduction are limited in the 
amount and reproducibility of the reduction attained.  In April 2013, Abbott Medical 
Optics (AMO) received USA FDA approval (P980040/S039) of the TECNIS Toric 1-
Piece IOL, Models ZCT150, ZCT225, ZCT300 and ZCT400 for the correction of aphakia 
and pre-existing corneal astigmatism of one diopter or greater.  In the IDE registration 
trial of the TECNIS Toric IOL, rotational stability was demonstrated and there were 
minimal subject complaints of visual distortions; however, there is the potential, 
particularly in the case of toric IOLs that correct for higher amounts of corneal 
astigmatism, that patients may experience spatial distortions related to axis 
misalignment, e.g., whether objects appear tilted or misshapen, etc.  As a condition of 
approval, a post-approval study is being conducted to evaluate visual distortions of the 
TECNIS Toric IOLs with ≥2.0 D of cylinder correction at the corneal plane, 
                                               
1 
Ferrer-Blasco, T. et al. Prevalence of corneal astigmatism before cataract surgery. J Cataract Refract Surg 
2009; 35: 70-75 
 

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Models ZCT300 and ZCT400 (or ZCT375 upon FDA-approval) (P980040/S043) and to 
ensure the continued safety of the approved devices.  This post-approval study will be 
conducted to evaluate visual distortions of the TECNIS Toric IOLs with ≥3.0 D of cylinder 
correction at the corneal plane (Models ZCT450, ZCT525, and ZCT600) and to also 
ensure the continued safety of these devices.   
3. 
CLINICAL HYPOTHESIS 
Severe visual distortions for the TECNIS Toric IOL Models ZCT450, ZCT525 and 
ZCT600 will be reported in less than 10 percent of the study population. 
4. 
STUDY DESIGN 
This study is a prospective, multicenter, bilateral, non-randomized, open-label,  
clinical study conducted at up to 20 sites in the USA.  Subjects will be bilaterally 
implanted with the high cylinder TECNIS Toric IOLs, Model ZCT300-ZCT600 with at 
least one eye of each subject implanted with TECNIS Toric IOL, Models ZCT450 or 
ZCT525 or ZCT600.  The fellow eye will be implanted with a high cylinder TECNIS Toric 
IOL, Model ZCT300-ZCT600 as chosen by the surgeon.  
JUSTIFICATION OF STUDY DESIGN 
The study is being conducted as a condition of approval in the USA to ensure the 
continued safety of the approved devices. 
5. 
ACRONYMS 
The following acronyms are used throughout the document:   
• UCDVA: uncorrected distance visual acuity 
• BCDVA: best corrected distance visual acuity 
• D:  diopters 
• IRB: Institutional Review Board 
6. 
STUDY OBJECTIVES AND ENDPOINTS 
The objective of this post-approval study is to evaluate the rates of severe visual 
distortions for the TECNIS Toric IOLs with ≥ 3.0 D of cylinder correction at the corneal 
plane (Models ZCT450, ZCT525 and ZCT600) in clinical practice and to ensure the 
continued safety of the approved devices.  
6.1 
PRIMARY ENDPOINT  
The primary endpoint is the rate of severe visual distortions based on data collected 
from a self-administered subject questionnaire (PRVDQ). 

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The rate of severe visual distortions is defined as the percentage of subjects who report 
a severe visual distortion under overall circumstances at 6 months postoperative for any 
of the following 5 visual distortion items of interest: 
o lines that slant, tilt, split or separate   
o flat surfaces appearing curved 
o objects appearing further away or closer than they actually are 
o objects appearing to have a different size or shape 
o physical discomfort related to vision 
 
Distortions will be assessed using the overall circumstance reply at the 
6-month visit.  The frequency and proportion of subjects reporting one or 
more of these items as severe will be used to determine the rate of 
severe visual distortions. 
 
6.2 
OTHER ENDPOINTS 
• Ratings of individual items included in the visual distortion questionnaire 
(PRVDQ) 
• Mean percent reduction in absolute cylinder 
• Mean refractive cylinder, mean refractive cylinder compared to intended, mean 
spherical equivalent and mean spherical equivalent compared to intended 
• Percent of eyes with absolute cylinder within 0.50 D and within 1.00 D of 
intended 
• Percent of eyes with spherical equivalent within 0.50 D and within 1.00 D of 
intended 
• Uncorrected distance visual acuity (monocular and binocular) 
• Best corrected distance visual acuity (monocular and binocular) 
• Rates of medical and/or lens findings 
• Rates of IOL repositioning procedures (secondary surgical intervention) due to 
IOL misalignment 
• Mean difference between IOL axis marker location and postoperative steep 
keratometry meridian    
• Rates of other adverse events  
 
7. 
STUDY PRODUCTS 
7.1 
INTRAOCULAR LENSES  
The TECNIS Toric 1-Piece IOL, Models ZCT450, ZCT525 and ZCT600 are posterior 
chamber, 1-piece, aspheric, hydrophobic acrylic foldable IOLs and are to be implanted in 

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the capsular bag following cataract extraction.  The TECNIS Toric Models ZCT450, 
ZCT525 and ZCT600 are similar to the TECNIS Toric Models, ZCT150, ZCT225, 
ZCT300, ZCT375 and ZCT400 with the exception of increased amounts of cylinder 
correction.  All TECNIS Toric IOLs have an anterior aspheric optic surface and a 
spherical posterior optic surface with a toric feature on the anterior optic surface to 
correct for astigmatism.   
INDICATION 
The TECNIS® Toric 1-Piece IOLs are indicated for the visual correction of aphakia and 
pre-existing corneal astigmatism of one diopter or greater in adult patients with or 
without presbyopia in whom a cataractous lens has been removed by 
phacoemulsification and who desire improved uncorrected distance vision, reduction of 
residual refractive cylinder, and increased spectacle independence for distance vision. 
The devices are intended to be placed in the capsular bag.  
The ZCT450, ZCT525 and ZCT600 lens models, in particular, are intended for cataract 
patients with pre-existing corneal astigmatism that, when taking surgically induced 
astigmatism into account, have approximately 3.00 D to 4.75 D of predicted corneal 
astigmatism to be corrected (Table 1). 
TABLE 1 
TECNIS Toric IOL, Models ZCT150- ZCT600 Astigmatism Correction Range 
ZCT IOL 
Model 
Cylinder Power (D) 
Correction  Range Based on 
Combined Corneal Astigmatism  
(Preoperative Kcyl
a + SIAb) 
IOL Plane Corneal Plane 
ZCT150c 
1.50 D 
1.03 D 
0.75 – 1.50 D 
ZCT225c 
2.25 D 
1.54 D 
1.50 – 2.00 D 
ZCT300 
3.00D  
2.06 D 
2.00 – 2.50 D 
ZCT375d 
3.75 D 
2.57  D 
2.50 – 3.00 D 
ZCT400 
4.00 D 
2.74 D 
2.75 – 3.25 D 
ZCT450 
4.50 D 
3.08 D 
3.00 – 3.50 D 
ZCT525 
5.25 D 
3.60 D 
3.50 – 4.00 D 
ZCT600 
6.00 D 
4.11 D 
4.00 – 4.75 D  
a Keratometric cylinder 
b Surgically induced astigmatism 
c IOL Model is not being used in this study 
dZCT375 will be used in place of the ZCT400 model following FDA-approval 
 
 
 

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STORAGE AND DISTRIBUTION 
All lenses will be obtained from the site’s own inventory.  All study lenses should be 
stored in the original packaging and kept in a dry place.  Lenses should not be stored in 
direct sunlight or at temperatures greater than 45° C (113°F).  Each lens is packaged in 
a lens tray and sealed in a peel-pouch.  The lens is sterile as long as the package has 
not been opened or damaged and the shelf-life expiration date has not been exceeded.  
7.2 
IOL IMPLANTATION SYSTEMS  
All lenses are to be implanted using either the UNFOLDER Platinum 1 Series 
Implantation System (DK7796 handpiece with the Platinum 1 Series cartridge,  
Model 1MTEC30) or the ONE SERIES Ultra Implantation System (DK7786 [plunger] or 
the DK7791 [twist] handpieces in combination with the ONE SERIES Ultra cartridge, 
Model 1VIPR30).   
8. 
STUDY POPULATION 
All subjects will be enrolled from the normal surgical cataract population at up to 20 sites 
in the U.S.A.  This study will include only subjects intended to undergo bilateral primary 
phacoemulsification cataract extraction and IOL implantation who have 
approximately 3.00 D to 4.75 D of corneal astigmatism in at least one eye requiring 
correction based on the combination of preoperative keratometric cylinder and the 
expected effect of SIA.  Up to 120 subjects will be enrolled to achieve approximately 80 
bilaterally implanted subjects.  A minimum of 15 subjects will be implanted with the 
TECNIS Toric ZCT600 in at least one eye; the remaining subjects are to be implanted 
with the TECNIS Toric ZCT450, ZCT525 or ZCT600 in at least one eye.  The eye with 
the highest toric power will define the toric group.  Both eyes will be implanted with a 
high cylinder TECNIS Toric IOL (Models ZCT300-ZCT600), but the fellow eye may have 
a lower cylinder correction toric IOL implanted (i.e. ZCT300, ZCT375 and ZCT400).  
Each site should enroll approximately 6 subjects, and no site may enroll more than 20% 
of the enrollment total.   
This study will include only subjects who meet all of the study inclusion and exclusion 
criteria in both eyes.  All subjects who meet the inclusion/exclusion criteria will be offered 
enrollment in the study.  Eligibility criteria may not be waived by the investigator.  Any 
questions regarding patient eligibility are to be discussed with AMO prior to subject 
enrollment.  
8.1 
INCLUSION CRITERIA  
Note: All criteria apply to each eye 
• Minimum 22 years of age 

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• Bilateral cataracts for which phacoemulsification extraction and posterior 
chamber IOL implantation have been planned 
• Preoperative keratometric cylinder of at least 2.00 D in both eyes.  At least one 
eye, when taking surgically induced astigmatism into account, must have 
approximately 3.00 D to 4.75 D of predicted corneal astigmatism to be corrected 
and qualify for implantation of ZCT450, ZCT525 or ZCT600 IOLs as determined 
by the web-based AMO Toric IOL Calculator 
o Most appropriate toric IOL model choice (ZCT450, ZCT525 or 
ZCT600) is to be based on the associated residual refractive 
cylinder (lowest) and axis  
• Clear intraocular media other than cataract  
• Availability, willingness, ability and sufficient cognitive awareness to comply with 
examination procedures and study visits 
• Ability to understand, read and write English in order to consent to study 
participation and complete a study questionnaire 
• Signed informed consent and HIPAA authorization 
 
8.2 
EXCLUSION CRITERIA  
Note: All criteria apply to each eye 
• Irregular corneal astigmatism 
• Any corneal pathology/abnormality other than regular corneal astigmatism 
• Previous corneal surgery 
• Recent ocular trauma or intraocular surgery that is not resolved/stable or may 
affect visual outcomes 
• Any pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) 
• Subjects with conditions associated with increased risk of zonular rupture, 
including capsular or zonular abnormalities that may lead to IOL decentration, 
including pseudoexfoliation, trauma, or posterior capsule defects 
• Known ocular disease or pathology that may affect visual acuity or that may 
require surgical intervention during the course of the study (macular 
degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled 
glaucoma, etc.) 
• Concurrent participation or participation during 30 days prior to preoperative visit 
in any other clinical study 
• Planned monovision correction 
•  Patient is pregnant, plans to become pregnant, is lactating or has another 
condition associated with the fluctuation of hormones that could lead to refractive 
changes 

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9. 
INVESTIGATOR SELECTION 
9.1  INVESTIGATOR QUALIFICATIONS 
AMO will select ophthalmic surgeons who have completed a residency in ophthalmology 
(or its documented equivalent), and are licensed to practice medicine and perform 
surgery at his/her investigative site. Each site will have one designated principal 
investigator; some sites may have additional implanting sub-investigators/surgeons.   
Investigators will be selected from surgeons who are experienced in small-incision, 
phacoemulsification and toric IOL implantation in cataract patients.  Additionally, 
investigators should have established their personalized A-constant for the TECNIS 
Toric ZCT.  All sites are required to have adequate staff support for reporting and subject 
follow-up, as well as the necessary instrumentation to conduct study testing. 
9.2 
INVESTIGATOR OBLIGATIONS 
Investigators are required to fulfill the following obligations: 
• Conduct the study in accordance with the relevant and current protocol.  Investigator 
will only make changes to a protocol after notifying and obtaining approval from 
AMO, the FDA or other governing agencies, and the Institutional Review Board 
(IRB), except when necessary to protect the safety, rights or welfare of subjects 
• Personally conduct and supervise the study 
• Maintain a list of appropriately qualified persons to whom the investigator has 
delegated significant trial-related duties 
• Be responsible for protecting the rights, safety and welfare of subjects under the 
investigator’s care and be responsible for the control and documentation of the 
devices under investigation 
• Inform patients that the device(s) are being used for regulatory post-approval 
purposes and that requirements relating to obtaining informed consent and IRB 
approval are met according to 21CFR50, 21CFR56, 21CFR812 and all other 
applicable laws and regulations 
• Maintain confidentiality as required by HIPAA or similar laws and regulations 
• Shall not obtain written informed consent from any subject to participate or allow any 
subject to participate before obtaining FDA and IRB approval  
• Document in each subject’s case history that informed consent was obtained prior to 
participation in the study as required by 21CFR812 
• Report to AMO and the reviewing IRB any adverse experiences that occur during the 
course of the study in accordance with applicable laws and regulations 
• Maintain adequate and accurate records in accordance with applicable laws and 
regulations and make available all study documents and subject medical records for 
inspection by either AMO, duly authorized regulatory agencies (e.g., FDA) and/or the 
IRB 

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• Submit progress reports on the investigation to AMO and the reviewing IRB at 
regular intervals, but no less often than yearly as required by 21CFR812.150  
• Ensure the IRB that is responsible for initial and continuing review of the study 
complies with applicable laws and regulations 
• Report all changes in research activity and all unanticipated problems involving risks 
to patients to the IRB and AMO 
• Provide sufficient accurate financial information to AMO to allow AMO to submit 
complete and accurate certification or disclosure statements as required by 
21CFR54.  Promptly update this information if any relevant changes occur during the 
course of the study or for up to one year following completion of the study 
• Comply with all other obligations of clinical investigators and requirements according 
to all applicable FDA regulations (e.g., 21CFR812), all other applicable laws and 
regulations, and all conditions of approval imposed by the reviewing IRB, the FDA 
and the regulatory agency of the country in which the study is being conducted 
• Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are adequately informed about the protocol, the study device, their study-
related duties and functions and agree to fulfill their obligations in meeting the above 
commitments. 
Investigators shall provide adequate time and resources to conduct and report on the 
study.  The Investigator, or delegate, shall notify AMO of any change in the conduct of 
the study including changes in study personnel assigned to the study project, location of 
the study device(s), or maintenance of study records, etc.  
9.3 
INVESTIGATOR APPROVAL  
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Study Files/Notebook.  Copies of IRB submissions and 
approvals should be forwarded to AMO.  Study sites will obtain IRB approvals and fulfill 
any other site-specific regulatory requirements.  The investigator is required to report to 
AMO within five working days any withdrawal of approval by the reviewing IRB for 
his/her participation in the investigation. 
Prior to the start of subject enrollment, the following documents must be signed and 
returned to AMO: 
• Confidentiality Agreement 
• Clinical Trial Agreement 
• Investigator Agreement/Protocol Signature page 
• Financial Disclosure form 
• Signed and dated copy of investigator’s current curriculum vitae 
• Copy of the investigator’s current medical license  

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• Hospital/Ambulatory Surgery Center Clinical Study Acknowledgement, if required 
By signing the study documents, the investigator agrees to conduct this study according 
to the obligations above and all other applicable regulatory and legal requirements. 
10. STUDY TIMELINE 
This study will be initiated following the USA FDA approval of the TECNIS Toric IOL, 
Models ZCT450, ZCT525, and ZCT600 for the correction of aphakia and pre-existing 
corneal astigmatism of three diopters or greater (P980040/S058) and FDA approval of 
this protocol.  The expected study timeline is presented in Table 3.
 
TABLE 3 
Expected Study Timeline 
Study Activity 
Expected Timing 
Begin IRB approvals, site initiations and 
subject enrollment 
JAN 2016:  Following FDA approval of 
Post-Approval Study protocol and 
PMA approval of TECNIS Toric IOL 
Models ZCT 450, ZCT525 and 
ZCT600    
Complete Site IRB approvals and 
initiations for initial 10 sites  
JUL 2016:  6 months (~1-2 sites/month)  
Complete Site IRB approval and 
initiations for additional sites 
JUN 2017 
Complete subject enrollment 
SEP 2018: (~1 subject/site/3 months) 
Complete subject follow-up 
APR 2019:  6 months  
NOV 2019:  12 months
a  
Complete primary-analysis, 6-month 
clinical study report 
JUL 2019:  3 months following completion of 
6-month exams 
Complete 1-year clinical study  report 
FEB 2020:  3 months following completion of 
1-year exams 
a  An additional 6 months may be necessary depending upon the number and timing of subjects returning 
for 1 year visits (due to reports of severe visual distortions at 6 months or the occurrence of an IOL 
repositioning procedure) 
 
Additionally, AMO will provide interim study reports every 6 months for the first two years 
following FDA approval of the lens models (July 31, 2015) and then annually thereafter 
until completion of the post-approval study.  Further details on interim reports are 
provided in Section 20.5 Interim Reports.  
11.  STUDY PLAN 
11.1 OVERVIEW 
This study will be conducted in accordance with U.S. Code of Federal Regulations, the 
Declaration of Helsinki, ISO 14155 and all other applicable laws and regulations.  The 
study will not begin until regulatory and IRB approvals have been obtained 

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This study is a prospective, multicenter, bilateral, non-randomized, open-label, clinical 
study conducted at up to 20 US sites.  Subjects will be bilaterally implanted with high 
cylinder TECNIS Toric IOLs, Models ZCT300-ZCT600 in both eyes with at least one eye 
implanted with a Model ZCT450, ZCT525 or ZCT600.  The eye with the highest toric 
power lens will determine the lens group.  Second-eye surgeries are to be performed 
within approximately 1 month (no more than 60 days) of the first-eye surgery, as second-
eye cataract surgeries are typically performed within 2 months of the first-eye surgery.  
Subjects will be examined postoperatively at 1 and 6 months following the second-eye 
surgery.  If a subject requires a lens repositioning procedure due to IOL misalignment or 
if a subject reports a severe visual distortion at 6 months, the subject will undergo a final 
visit at 1 year.  Additional visit schedule details are provided in Section 11.2 Visit 
Schedule. 
At the 1-month visit, a spectacle and/or contact lens prescription will be offered to each 
subject.  Postoperative procedures will include uncorrected and best corrected visual 
acuities, manifest refraction, intraocular pressure and biomicroscopic slit-lamp 
examination.  In addition, if the subject has a spontaneous report of any of the 5 visual 
distortion items of interest or of blurred or hazy vision, the questionnaire will be 
administered and keratometry and toric IOL axis measurements will be performed.  
At the 6-month visit, the postoperative procedures will include a subject questionnaire for 
determination of visual distortions, keratometry, uncorrected and best corrected visual 
acuities, manifest refraction, intraocular pressure and a biomicroscopic slit-lamp 
examination for determination of toric IOL axis position and for any adverse events. 
If outside of a scheduled study visit, a subject has a spontaneous report of; 1) any of the 
5 visual distortion items of interest or 2) blurred or hazy vision at one month 
postoperatively or later, the PRVDQ questionnaire will be administered and keratometry 
and toric IOL axis measurements will be performed.  Exam details will be documented 
on an unscheduled visit form.  
If a subject reported a severe visual distortion in the questionnaire or experienced a 
serious or device-related adverse event at any unscheduled study visit, uncorrected 
distance visual acuity, best corrected distance visual acuity, manifest refraction, 
keratometry, intraocular pressure and biomicroscopic slit-lam examinations will also be 
performed. 
A 1-year examination will be required only if the subject reports a severe visual distortion 
at the 6-month examination or experienced an IOL repositioning procedure (due to IOL 
misalignment during the study). 

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As the Informed Consent Form is signed at the beginning of the preoperative study 
exam, some subjects may not qualify after study-specific testing is performed.  Subjects 
will be considered screen-failures if they do not qualify or if they qualify but decide not to 
proceed with surgery. These subjects will be exited from the study.   
Study-specific preoperative testing for this protocol includes the administration of the 
subject questionnaire assessing visual distortions as well as any other preoperative 
procedures that are not already performed during the investigator’s routine cataract 
evaluation for astigmatic patients (e.g., potential visual acuity).  Documentation via the 
AMO Toric IOL Calculator options of toric power lens choice for each eye of each 
subject is required.   
Preoperative testing to be performed for each eye includes the following: 
• Informed consent documentation  
• Subject demographic information  
• Ocular history, including presence of ocular pathology for each eye  
• Potential best-corrected distance visual acuity for each eye (Note:  20/30 or better is 
recommended for study inclusion; may be performed by surgeon estimation) 
• Monocular uncorrected distance visual acuity (Snellen)  
• Monocular best corrected distance visual acuity (Snellen)  
• Manifest refraction (Snellen) for each eye 
• Keratometry for each eye  
• Intraocular pressure for each eye 
• Ocular medications 
• Cataract type and density for each eye 
• Dilated fundus exam results for each eye (recommended) 
• Medical and lens findings from a biomicroscopic slit-lamp exam for each eye 
• Axial length, vertex distance, spherical equivalent IOL power and spherical 
equivalent targeted refraction (emmetropia, within ±0.50 D) for each eye using the 
investigator’s preferred biometry method 
•  A-constant used for spherical equivalent IOL power determination  
• Surgeon-estimated surgically induced astigmatism (SIA) and planned incision 
location 
• Documentation of the AMO Toric IOL Calculator choice of ZCT toric power for each 
eye and corresponding residual refractive cylinder and axis for each eye  
o Investigator to determine the most appropriate toric IOL model (ZCT450, ZCT525 
or ZCT600 in at least one eye of each subject) based on the associated 
residual refractive cylinder (lowest) and axis  
• Subject Questionnaire  

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LENS POWER CALCULATIONS AND IOL SELECTION:   
For lens power calculations, the investigator’s personalized A-Constant for the TECNIS 
Toric ZCT lens is to be used.  The spherical equivalent lens power, as determined by the 
investigator’s standard biometry methods, should be calculated to achieve emmetropia 
(± 0.50 D) at distance for all eyes.  Intentional overcorrection or under-correction (i.e., 
monovision or outside ± 0.50 D) should NOT be planned for either eye; however, 
surgeons may adjust the targeted refraction as necessary to achieve emmetropia based 
on their surgeon factor, study subject experience and/or subject first-eye outcomes.     
In order to verify subject eligibility and to optimize toric IOL selection and axis placement, 
investigators will use the web-based AMO Toric IOL Calculator 
(www.TecnisToricCalc.com) to determine the appropriate TECNIS Toric IOL model for 
each eye (ZCT450, ZCT525 and/or ZCT600 must be implanted in at least one eye per 
subject for this study).  Note that the AMO Toric IOL calculator provides toric IOL options 
based on predicted astigmatism, i.e., the vector sum of pre-existing corneal astigmatism 
and the expected effect of SIA.  For this study, subjects are to have corneal astigmatism 
that, when taking SIA into account, have approximately 3.00 D to 4.75 D of predicted 
corneal astigmatism to be corrected and qualify for implantation of a ZCT450, ZCT525 
and/or ZCT600 IOL in at least one eye (with the fellow eye also qualifying for 
implantation of ZCT300-ZCT600) as determined by the web-based AMO Toric IOL 
Calculator.  Therefore, toric IOL calculations are to be performed for all subjects in this 
study and the toric IOL model selections chosen by the investigator via the AMO Toric 
IOL Calculator are to be printed and maintained as source documentation.   
Note: Because lenticular astigmatism in the crystalline lens may influence the 
determination of the amount of astigmatism to be corrected, it is vital that corneal 
astigmatism (keratometry readings) and not refractive cylinder data be used for toric IOL 
calculations. 
11.4  STUDY LENS SUPPLY  
All lenses will be pulled from the site’s own inventory and re-ordered per the standard 
practice at the site.  Two lenses should be available for each case, a primary and a 
back-up lens.     
11.5  OPERATIVE PROCEDURES  
The investigator should use his or her standard, small-incision, phacoemulsification, 
cataract extraction surgical technique.  Lenses should be folded for implantation and 
inserted into the capsular bag using one of the AMO-validated insertion systems.  No 
additional refractive procedures are to be performed during the operative 

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procedure or throughout the postoperative study period (e.g., LRI, OCCI, CRI, AK, 
PRK, LASIK or LASEK). 
Following lens insertion, the TECNIS Toric 1-Piece IOL is to be precisely aligned with 
the intended axis of placement using the imaginary line formed by the axis orientation 
marks at each of the haptic/optic junctions of the IOL, identifying the flat meridian of the 
optic.  Carefully remove all viscoelastic from the capsular bag.  Special care should be 
taken to ensure proper positioning of the TECNIS Toric IOL at the intended axis 
following viscoelastic removal and/or inflation of the capsular bag at the end of the 
surgical case.  Residual viscoelastic and/or over-inflation of the bag may allow the lens 
to rotate, causing misalignment of the TECNIS Toric IOL from the intended axis.    
Operative case report forms will include the following information: 
• Date of surgery 
• Operative eye 
• IOL model, power and serial number 
• Incision location  
• Surgical complications  
• Other surgical procedures 
• IOL placement (e.g., within capsular bag, proper alignment, etc.) 
• Wound closure (e.g., suture required) 
• Adverse events 
 
11.6 POSTOPERATIVE PROCEDURES  
Postoperatively, subjects will be examined according to the schedule in Section 11.2, 
Visit Schedule.  All subjects will be examined at the 1- and 6-month study visits.  If a 
subject requires a lens repositioning procedure due to IOL misalignment or if a subject 
reports a severe visual distortion at 6 months, the subject will also undergo a final visit at 
1 year.    
At the 1-month visit, a spectacle and/or contact lens prescription will be offered to each 
subject.  Postoperative procedures will include uncorrected and best corrected visual 
acuities, manifest refraction, intraocular pressure and biomicroscopic slit-lamp 
examination.  In addition, if the subject has a spontaneous report of any of the 5 visual 
distortion items of interest or of blurred or hazy vision, the questionnaire will be 
administered and keratometry and toric IOL axis measurements will be performed.  
Primary 6-month postoperative data collection consists of administration of a subject 
questionnaire for determination of visual distortion reports, manifest refraction, distance 
visual acuities, intraocular pressure, keratometry, and a biomicroscopic slit-lamp exam 
for determination of toric IOL axis position and for any adverse events.  

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If outside of a scheduled study visit, a subject has a spontaneous report of; 1) any of the 
5 visual distortion items of interest or 2) blurred or hazy vision at one month 
postoperatively or later,, the PRVDQ questionnaire will be administered and keratometry 
and toric IOL axis measurements will be performed.  Exam details will be documented 
on an unscheduled visit form.  
If a subject reports a severe visual distortion or has experienced a serious or 
device-related adverse event at any unscheduled study visit, uncorrected distance visual 
acuity, best corrected distance visual acuity, manifest refraction, keratometry, intraocular 
pressure and biomicroscopic slit-lam examinations will be performed.   
Subjects should be assessed at each visit for occurrence of and/or change in status of 
any adverse events, particularly serious and/or device-related adverse events.  If a 
serious or device-related adverse event occurs, details of the event are to be captured 
on an adverse event CRF and the exam details are to be captured on the appropriate 
visit CRF (i.e., 1-month, 6-month, 1-year or unscheduled).  The event will be followed up 
as necessary and details captured on adverse event follow-up CRFs until resolution. 
See Section 12.0, Adverse Events, and Appendix D Adverse Event Reporting 
Instructions, for further information.  
If a serious or device-related adverse event occurs at or prior to the 6-month visit, details 
of the event will be collected at the time of the event using an adverse event form.  If the 
adverse event results in an IOL repositioning procedure due to misalignment, the 
questionnaire should be administered prior to the procedure to collect information 
regarding visual distortions.  Keratometry and toric IOL axis measurements will be 
performed prior to the repositioning procedure to collect data regarding the IOL 
misalignment.   
If correction is required during the study postoperatively, spectacles or contact lenses 
will be prescribed; however, no additional refractive procedures (LRI, AK, etc.) are 
allowed until after completion of the 6-month study visit.  If a subject is required to return 
for a 1-year exam (due to a severe visual distortion at 6 months or an IOL repositioning 
procedure during the study), a refractive enhancement (LRI, AK, etc.) may be performed 
prior to the 1-year exam but must be reported on the 1-year case report form; this 
enhancement will not be considered a secondary surgical intervention at this time. 
The postoperative case report form will include the following information (Appendix A): 
• Confirmation of offering of spectacle and/or contact lens prescription: 1-month visit 
only 
• Questionnaire: (Following completion of the questionnaire by the subject, the 
questionnaire is to be reviewed by the site personnel for reports of severe visual 
distortions), 6-month and 1-year visits and also at 1-month or unscheduled visits only 

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if there is a spontaneous report of visual distortion or prior to an IOL repositioning 
procedure at that visit.   
• Keratometry: 6-month and 1-year visits; also at 1-month and unscheduled visits if 
there is a spontaneous report of visual distortion or prior to an IOL repositioning 
procedure at that visit.  
• Monocular uncorrected distance visual acuity, Snellen: all scheduled postoperative 
visits and unscheduled visits if a severe visual distortion or a serious or 
device-related adverse event is reported at that visit. 
• Binocular uncorrected distance visual acuity, Snellen: 1- month, 6-month and 1-year 
visits; also at unscheduled visits if a severe visual distortion or a serious or 
device-related adverse event is reported at that visit. 
• Manifest refraction (Snellen): 1- month, 6-month and 1-year visits; also at 
unscheduled visits if a severe visual distortion or a serious or device-related adverse 
event is reported at that visit. 
• Monocular best corrected distance visual acuity, Snellen: 1- month, 6-month and 
1-year visits; also at unscheduled visits if a severe visual distortion or a serious or 
device-related adverse event is reported at that visit. 
• Binocular best corrected distance visual acuity, Snellen: 1- month, 6-month and 
1-year visits; also at unscheduled visits if a severe visual distortion or a serious or 
device-related adverse event is reported at that visit.  
• Toric IOL axis measurement by dilated slit-lamp examination (Refer to Appendix B 
for measurement instructions): 6-month and 1-year visits; also at 1-month and 
unscheduled visits if there is a spontaneous report of visual distortion or prior to an 
IOL repositioning procedure at that visit. 
• Medical and lens findings from biomicroscopic slit-lamp exam: 1- month, 6-month 
and 1-year visits; also at unscheduled visits if a severe visual distortion or a serious 
or device-related adverse event is reported at that visit.  Findings of aqueous cells 
and flare, corneal edema, posterior capsule striae, posterior capsular opacification 
and IOL glistenings are to be rated using a standardized grading scales provided in 
Appendix C.   
• Ocular medications  
• Intraocular pressure 
• Dilated fundus exam, if medically indicated  
• Occurrence of Nd:YAG capsulotomy(ies) 
• Occurrence of any adverse events  
11.7 UNSCHEDULED VISITS  
A visit is considered an unscheduled study visit when it occurs other than at the 
specified 1- or 6-month study visits AND at which a serious or device-related adverse 
event is reported OR if the subject has a spontaneous report of any of the 5 visual 
distortion items of interest (lines that slant, tilt or separate, flat surfaces appearing 
curved, objects appearing further away or closer than they actually are, objects 
appearing to have a different size or shape, or physical discomfort related to vision as 
defined in Section 6.1) or of blurred or hazy vision at 1 month postoperatively or later.    

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For example, if the subject is seen for a routine (non-study) 3-month follow-up visit and 
there are no serious or device-related adverse events or any spontaneous report of 
visual distortion(s) of interest or of blurred or hazy vision at 1 month postoperatively or 
later, this would NOT be captured on an unscheduled visit form.  If however, the subject 
commented on a visual distortion as listed above or a serious or device-related adverse 
event was noted at this visit, this visit would be captured on an unscheduled visit form. If 
a subject reports a visual distortion at an unscheduled visit, the PRVDQ questionnaire is 
to be administered, and keratometry and toric IOL axis measurements are to be 
performed.   
If the subject reported a severe visual distortion in the questionnaire or if a serious or 
device-related adverse event was reported at any unscheduled visit, uncorrected and 
best corrected visual acuities, manifest refraction, keratometry, intraocular pressure and 
biomicroscopic slit-lam examinations will be performed.  If the event results in an IOL 
repositioning procedure (secondary surgical procedure), the PRVDQ questionnaire is to 
be administered and keratometry and toric IOL axis measurements are to be performed 
PRIOR to the IOL repositioning procedure for evaluation of visual distortions arising from 
IOL misalignment.  
Data to be collected on unscheduled visit forms (due to serious or device-related 
adverse event or spontaneous report of visual distortion) include, as applicable: 
• Questionnaire - in the event of a spontaneous report of visual distortion or prior to 
an IOL repositioning procedure 
• Snellen manifest refraction 
• Uncorrected and best corrected distance visual acuity using Snellen  
• Intraocular pressure 
• Slit-lamp examination for medical and/or lens findings  
• Keratometry 
• Toric IOL axis measurement 
• Dilated fundus exam, if medically indicated 
• Ocular symptoms 
• Adverse events 
• Medications 
11.8 EXIT OF SUBJECTS  
An Exit Case Report Form will be completed for all subjects, either when they complete 
the study or if they exit early.   

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It is the responsibility of the investigator to provide complete follow-up data to AMO for 
each subject, and every attempt will be made to gather that complete follow-up data for 
all subjects enrolled as missing data can have a negative effect on the study results.. 
Patients who would be traveling, relocating or otherwise unavailable for postoperative 
follow-up visits should not be chosen for this clinical study.  
SUBJECT FOLLOW-UP 
To minimize subjects lost to follow-up, subjects will be provided compensation for their 
time and participation in the study at the 1- and 6-month postoperative exams.  
Additionally, sites will be compensated for completion of the 1- and 6-month exams and 
will be provided frequent listings of upcoming 1- and 6-month subject examinations as 
well as follow-up reminder cards to send to the subjects.  It is anticipated that at least 
90% of subjects will be available for the 6-month study visit (i.e., no more than a 10% 
lost-to-follow-up rate at 6 months postoperatively). If a subject has a confirmed report of 
severe visual distortion(s) per the questionnaire, prior to the 6-month exam, every effort 
is to be made to ensure that subject returns for the 6-month exam.  The investigative site 
shall make a minimum of at least three attempts (phone calls/emails and/or letters) to 
locate missing subjects.   
SUBJECT DISCONTINUATION 
Subjects will be discontinued from the study if the study lens is removed or if the subject 
dies.  Subjects will be considered “lost-to-follow-up” from the study only if irretrievably 
lost for unavoidable reasons such as: subject moved/unable to locate, subject 
uncooperative/refuses further study participation, subject ill/unable to travel.  The site 
shall document at least three attempts (phone calls/emails and/or letters) to locate lost-
to-follow-up subjects and the investigator should notify AMO prior to exiting a subject 
from the study.  If a subject is exited from the study, the investigator will, if at all possible, 
have the subject return for a final study visit.   In the event of subject relocation, efforts 
must be made by the investigator to secure follow-up information (i.e., slit-lamp findings 
and general visual acuity, etc.) from the subject’s new physician.   
If a subject is exited early from the study, the investigator will complete an Exit Case 
Report Form indicating the reason for study exit.  In the event of a lens removal or other 
serious adverse event, the subject may be exited from the study; however, efforts must 
be made by the investigator to follow the subject until resolution of the adverse event. 
Note:  A subject may be exited from the study if complications occur during the first-eye 
surgery and the planned study lens is not implanted; however, the eye will be followed 
until the resolution of the complication prior to exiting the subject from the study.  If a 
complication occurs during the second-eye surgery and the planned study lens is not 
implanted in the second eye, the subject is to be followed according to the protocol for 

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the first eye (although data may be analyzed separately), and the second eye will be 
followed for safety until resolution of the complication.      
11.9 PROTOCOL DEVIATIONS  
Any departure from the protocol procedures represents a protocol deviation.  Protocol 
deviations may be subject-based (e.g., inclusion/exclusion criteria, informed consent 
deviation, etc.) or procedural-based (e.g., out-of-interval visits, non-compliance with 
testing procedures, etc.).  All protocol deviations will be documented using protocol 
deviation case report forms.  Any deviation made to protect the life or physical well-being 
of a subject in an emergency as well as any use of the study device without obtaining 
informed consent must be reported to AMO within 5 working days. Protocol deviations 
will be monitored by AMO, and if the non-compliance is persistent or egregious, AMO 
may take action, including but not limited to termination of the investigator’s participation 
in the study.  The investigator is also responsible for informing the reviewing IRB of 
instances of protocol non-compliance in accordance with the IRB requirements. 
12. ADVERSE EVENTS AND PRODUCT COMPLAINTS  
12.1  ADVERSE EVENT DEFINITIONS 
Adverse Event (AE) 
An adverse event is defined (following ISO 14155) as any untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs (including abnormal laboratory 
findings) in subjects, users or other persons, whether or not related to the study device.   
Serious Adverse Event (SAE) 
An adverse event is considered serious (following ISO 14155) if it is an untoward 
occurrence which may or may not be related to use of the study device that 
• is sight- or life-threatening,  
• results in death,  
• requires inpatient hospitalization or prolongation of hospitalization (a planned 
hospitalization for a pre-existing condition is not considered a serious adverse 
event), 
• results in permanent impairment of a body structure or body function,  
• necessitates medical or surgical intervention to prevent permanent impairment to a 
body structure or function, or 
• results in fetal distress, fetal death or a congenital abnormality or birth defect 
Device-Related Adverse Event 
A device-related adverse event is defined as any adverse event that is believed to be 
definitely, probably or possibly related to the study device (following the guidelines in 
Section 12.4, Causal Relationship).  A device-related event is considered an adverse 

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device effect (ADE; following ISO 14155) resulting from any untoward or unintended 
response to the study device.   
Study-Specific Serious Anticipated Adverse Events 
The following is a list including, but not limited to, ocular adverse events that are 
anticipated and must be reported to AMO for this study.  Any events that are unlikely but 
anticipated (i.e., endophthalmitis) will be reported to the FDA and other appropriate 
regulatory agencies. 
• Endophthalmitis/Intraocular infection 
• Hypopyon 
• Hyphema 
• IOL dislocation 
• Cystoid macular edema 
• Pupillary block 
• Retinal detachment/tear 
• Persistent corneal edema 
• Persistent iritis 
• Persistent raised IOP requiring treatment 
• Axis misalignment requiring secondary surgical intervention (e.g., repositioning) 
• Tilt and decentration requiring secondary surgical intervention (e.g., repositioning) 
• Residual refractive error resulting in a secondary surgical intervention 
• Residual lens remnants resulting in a secondary surgical intervention 
• Visual symptoms requiring secondary surgical intervention 
NOTE 1:  Wound burps during the first week postoperatively, suture removal, planned 
blepharoplasty and Nd:YAG capsulotomy (for PCO) are not considered adverse events 
for this study. 
NOTE 2: Raised IOP requiring treatment, cornea edema, and iritis will only be 
considered serious if persistent at the final study visit (120-180 days postoperative) or 
sight-threatening at the time of occurrence.  Treatment merely to hasten the resolution of 
such conditions (and not intended to prevent permanent damage to the eye) will not be 
reported as serious adverse events.   
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) 
Any UADE (USA 21CFR 812.3(s)) or USADE (ISO 14155) is defined as any serious 
adverse effect on health or safety or any life-threatening problem or death caused by, or 
associated with, a device, if that effect, problem, or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan (i.e., this protocol), 

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application (including a supplementary plan or application), or risk assessment, or any 
other unanticipated serious problem associated with a device that relates to the rights, 
safety, or welfare of subjects.   
12.2 PRODUCT COMPLAINT/DEVICE DEFICIENCY DEFINITION 
A product complaint/device deficiency is defined (21 CFR 820.3(b) and ISO 14155) as 
any alleged deficiency related to the identity, quality, durability, reliability, safety, 
effectiveness, or performance of a device. Product complaints can pertain to any 
marketed AMO device being used in the study.  The investigator is to assess whether 
the deficiency could have led to a serious adverse event without suitable action or 
intervention or under less fortunate circumstances. 
12.3  ADVERSE EVENT AND COMPLAINT REPORTING REQUIREMENTS 
All adverse events and any complaint encountered using any AMO product, regardless 
of severity and whether or not attributed to the study device(s), are to be reported to 
AMO and recorded on the case report form corresponding to the visit during which 
awareness of the event occurred.  All serious adverse events, whether anticipated or 
unanticipated, and all adverse device effects shall be reported using a serious or device 
related adverse event case report form and forwarded to AMO.  Adverse events are also 
to be reported to the reviewing IRB as per the IRB’s reporting requirements.  If required, 
adverse events will be reported to the appropriate regulatory agencies (e.g., FDA) 
according to all applicable laws and regulations.  Specific instructions on notification 
procedures to AMO are included in Appendix D, Adverse Event Reporting.   
Reporting of adverse events shall follow the USA Code of Federal Regulations 
(21CFR812) for sites in the USA.  General guidelines are provided below: 
Adverse Event Reporting 
An adverse event that is not serious or device-related is to be reported to AMO in a 
timely manner.  Notification of non-serious and non-device related adverse events will 
occur by recording events on the CRF when noted.  Such adverse events are also to be 
reported to the reviewing IRB per their reporting requirements.  
Complaints/Device Deficiency Reporting  
A general product complaint or device deficiency is to be reported to AMO in a timely 
manner.  Notification of complaints/device deficiencies will occur by either recording 
complaints on the CRF when the complaint occurred (e.g. operative form) or by a phone 
call to the Sponsor.  Any device deficiency that could have led to a serious adverse 
event without suitable action or intervention, or under less fortunate circumstances, must 
be reported to the sponsor immediately (no later than 48 hours after detection). Device 

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deficiencies that could have led to a serious adverse event should also be reported to 
the investigator’s IRB per their reporting requirements. 
Serious and/or Device-Related Adverse Event Reporting 
In the event of a serious adverse event (SAE), which may or may not be related to use 
of the study device, or a device-related adverse event, AMO must be notified 
immediately (no later than 48 hours after detection).  Any SAE and/or device-related AE 
is to be reported by phone and by submitting a completed Serious and/or Device-
Related Adverse Event CRF.  Any SAE or device-related AE should also be reported to 
the investigator’s IRB per their reporting requirements. 
Unanticipated Adverse Device Effect (UADE)/Unanticipated Serious Adverse 
Device Effect (USADE) Reporting 
If during the study, a serious adverse event occurs that may reasonably be regarded as 
study-device-related and was not previously expected in nature, severity, or degree of 
incidence, the investigator is to report the UADE/USADE to AMO within 48 hours, and to 
the investigator’s IRB as soon as possible (and no later than 10 working days after 
learning of the event for sites in the USA as required by 21CFR812). 
12.4 CAUSAL RELATIONSHIP  
The investigator should always be alert to adverse events that may be related to the 
study device or use of the study device (in the implantation procedure).  An attempt 
should be made in every case to determine if the event may be device-related.   
The following definitions are to be used as guidelines in determining the relationship 
between the event and the study devices: .   
Definitely related: 
There is a definite causal relationship between the adverse 
event and the device or implantation procedure. 
Probably related:   
There is a reasonable possibility of a causal relationship 
between the adverse event and the device or implantation 
procedure. 
Possibly related:   
The adverse event has not been determined to be related to the 
device or implantation procedure, but no other cause has been 
definitively identified and the device or implantation procedure 
cannot be ruled out as a possible cause. 
Unlikely to be related: The possibility of a potential causal relationship between 
adverse event and the device or implantation procedure could 
exist, but the adverse event is most likely explained by causes 
other than the device or implantation procedure. 
Not related: 
There is no possibility of a causal relationship between the 
adverse event and the device or implantation procedure. 

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If an adverse event is believed to be definitely, probably or possibly related to the study 
device, the event will be considered device-related.   
12.5 ADVERSE EVENT FOLLOW-UP 
For every serious or device-related adverse event, appropriate measures should be 
undertaken to treat and/or monitor the subject until resolution occurs.  Obtain and 
maintain in the subject
's files all pertinent medical data relating to the event including the 
subject’s medical records and medical reports and/or judgments from colleagues or 
outside specialists who assisted in the treatment and follow-up of the subject. The 
investigator should keep AMO closely informed as to the outcome of serious and/or 
device-related adverse events, thereby allowing AMO to comply with the appropriate 
regulatory reporting requirements.  A Serious and/or Device-Related Adverse Event 
Update CRF should be completed each time the subject returns to the investigator or 
other specialist(s) for follow-up of serious and/or device-related adverse event until 
resolution of the event.  Any subject who is exited from the study due to a serious and/or 
device-related adverse event will be followed until the outcome is determined. 
13. PROTOCOL CHANGES/AMENDMENTS  
If the investigator desires to modify any procedure and/or the design of the study, he or 
she must contact and obtain consent from AMO regarding the proposed changes prior to 
implementation.  Any modifications (including additional data collection) require approval 
by the FDA and all other appropriate regulatory agencies, as well as approval of the 
governing IRBs prior to implementation.   
14. ETHICS REVIEW AND PATIENT WELFARE 
14.1 INSTITUTIONAL REVIEW BOARD (IRB) 
It is the responsibility of the investigator to obtain prospective approval of the study 
protocol, protocol amendments or changes, informed consent forms and other relevant 
documents (e.g., advertisements) from the IRB.  All correspondence with the IRB should 
be retained in the Investigator Notebook.  Copies of IRB submissions and approvals 
should be forwarded to AMO. 
The investigator is responsible for notifying the IRB of reportable adverse events as well 
as any other circumstance in which additional procedures outside the protocol were 
conducted to eliminate apparent hazards to subjects. 
14.2 INFORMED CONSENT 
The current version of the IRB-approved study informed consent must be signed by 
each study subject prior to any study-specific examinations being performed.  The 
IRB-approved informed consent is to be signed and dated by the subject as well as by 

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the person who conducted the informed consent discussion.  The signed informed 
consent will be maintained by the investigator as a permanent part of the subject’s 
medical records.  A copy of the signed and dated form is to be provided to the subject.  
The investigator will provide AMO acknowledgement on the preoperative case report 
form that a signed agreement of informed consent has been obtained and is in the 
investigator’s possession for each subject.  As required by 21CFR812 Part G, the site 
shall document in the source documents that informed consent was obtained prior to 
participation in the study for each subject enrolled. 
NOTE:  The informed consent process also includes obtaining the subject’s signature on 
an Authorization for Use/Disclosure of Health Information for Research Form.  
NOTE:  The sponsor will secure appropriate insurance for study subjects prior to study 
start. 
15.  DOCUMENTATION 
15.1 SOURCE DOCUMENTS 
Source documents must be kept for all study subjects.  Source documents may include 
a subject’s medical records, hospital charts, clinic charts, the investigator’s subject study 
files, as well as results of any diagnostic tests or procedures such as topographies or 
laboratory tests with photographs or instrument printouts. 
Each site is expected to adhere to the clinic’s own standard documentation requirements 
for medical charts/clinic notes.  However, for the purposes of this clinical study, the 
medical charts/clinic notes must also include, at a minimum, the following data that will 
be considered source data and will be reviewed by AMO: 
• Subject’s name and study identification number 
• Subject’s contact information 
• Study protocol number and the Sponsor name (AMO) 
• A statement that informed consent was obtained prior to participation in the study 
(including the date)  
• Dates of all subject visits and surgeries throughout the duration of the study 
• Implant serial number identification  
• Concurrent medications 
• Corrected and uncorrected distance visual acuity  
• Manifest refraction 
• Occurrence and status of any operative complications, postoperative medical or lens 
findings and adverse events 
• Occurrence and status of any subject complaints, e.g., ocular/visual symptoms 

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• The date the subject exited the study, and a notation as to whether the subject 
completed the study or reason for early exit. 
15.2 SUBJECT CONFIDENTIALITY 
Subjects will be assigned a site/subject number to maintain subject confidentiality.  
Subject names may possibly be disclosed to  AMO or regulatory agencies during 
inspection of medical records related to the study, but reasonable precautions will be 
taken to maintain confidentiality of personal information to the extent permitted by 
applicable laws and regulations. 
15.3 CASE REPORT FORM COMPLETION 
This study will use an electronic data capture system using electronic case report forms..  
Case report forms will be completed in accordance with instructions provided to the site 
prior to study start. The investigator is responsible for ensuring that data are properly 
recorded on each subject’s case report forms and related documents.  Prior to database 
lock, the investigator will verify completeness and accuracy of data submitted to AMO.  
15.4 STUDY SUMMARY 
A final investigator’s summary will be provided to AMO and the reviewing IRB within 
three months after termination or the completion of the study or the investigator’s part of 
the investigation.  
16.  MONITORING  
AMO will perform three types of monitoring to ensure compliance with regulations: data 
monitoring, administrative monitoring, and safety monitoring. 
16.1 DATA MONITORING 
In order to ensure a well-controlled clinical trial, AMO will follow specific data monitoring 
procedures.   
Subject data will be entered to AMO’s data management system via completion of case 
report forms by the investigative site.  Requests for data clarification will be handled 
through this same data management system.   
To minimize data omissions and inconsistencies on clinical reports and to ensure that 
data are accurately transcribed to computer data files, AMO will follow internal data 
processing procedures that include automated and manual quality control checks to 
identify any data discrepancies.  Any such items will be resolved and documented as 
needed on the case report forms by the investigative site via AMO’s data management 
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Prevention of Missing Data 
Methods used to safeguard against missing data that can have deleterious effects on the 
study integrity and reliability of its outcomes will include training study staff with on-site 
programs.  In addition, subjects will be encouraged at the time of informed consent to 
avoid missing study visits, as missing data may affect the study reliability and diminish 
the scientific value of their contribution to the study.  
16.2 ADMINISTRATIVE MONITORING 
Administrative monitoring procedures will ensure that subjects and case report forms 
can be traced and will allow monitoring of investigator progress and compliance.   
Device Accountability 
As the study IOLs  are commercially available, supply records for the lenses will solely 
be the responsibility of the site and managed by their customary methods.  However, 
documentation of the lenses that are implanted in study subjects will be maintained and 
monitored by AMO personnel. 
Site Monitoring Plan 
Prior to performing any study implants, the requirements of the study and reporting 
mechanisms will be explained to each investigator either personally at the investigative 
site or at a formal study investigator meeting.  When necessary, a pre-study site 
qualification visit may be performed to assess the adequacy of the site to perform the 
study for sites that have not previously worked with AMO or have undergone significant 
changes, or have not been visited in the past year.   
Throughout the duration of the study, site visits to monitor compliance to this protocol will 
be made at each investigative site.  During a routine site monitoring visit, AMO will 
review informed consent documents and subject eligibility, and the data on study case 
report forms will be verified against subject charts and other source documents to 
ensure complete and accurate reporting.  The subject files will also be reviewed to 
assure that all adverse events and any issues encountered with AMO products have 
been reported in a timely fashion.   
AMO will also review source documents to verify that all required items have been 
documented in the subject medical charts.  Refer to Section 15.1, Source Documents, 
for a list of items that are required for source documentation.  In addition to subject files, 
study logs will be checked.  Training on study-specific procedures may also be 
conducted during monitoring visits.   
Upon study completion, a final close-out site visit to each site will be made to monitor the 
last of the subject data records and finalize any outstanding study issues.  

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A separate Study Monitoring Plan will be established prior to study start that will define 
the type and frequency of monitoring visits and frequency of record monitoring.  
16.3 MEDICAL OVERSIGHT  
The medical monitor will be available throughout the clinical trial to review study results 
and to answer any questions from investigators. The medical monitor will review and 
assess any reports of serious and/or device-related adverse events and discuss these 
with the reporting investigator(s) as necessary. The medical monitor, as well as any 
other qualified personnel designated by AMO, shall also review study reports. 
17.  PUBLICATIONS 
Refer to the Clinical Trial Agreement for information regarding AMO publication policies. 
18. RISK ANALYSIS 
POTENTIAL RISKS AND RISK MANAGEMENT 
RISKS OF THE TECNIS TORIC IOLS 
The TECNIS Toric IOLs are designed to provide improved uncorrected distance vision, 
reduction in residual refractive cylinder, and increased spectacle independence for 
distance; however, glasses may still be needed to improve distance vision and/or to 
have useful vision for intermediate or near tasks. In addition, rotation of the TECNIS Toric 
IOLs away from its intended axis can reduce its astigmatic correction. Misalignment greater 
than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning 
should occur as early as possible prior to lens encapsulation. These risks are not unlike 
other lenses of this kind.  As the TECNIS Toric ZCT450, ZCT525 and ZCT600 IOLs 
have higher amounts of  cylinder correction, there may be an increased risk of visual 
distortions arising from misalignment. 
GENERAL RISKS OF CATARACT SURGERY AND IOL IMPLANTATION 
There are risks and complications associated with cataract surgery and IOL implantation 
in general.  These can include worsening of vision, hemorrhage, loss of corneal clarity, 
inflammation, infections, retinal detachment, pupil changes, glaucoma, etc.  
Complications can result in poor vision, loss of vision or loss of the eye.   
RISK MANAGEMENT 
Subjects will be closely monitored thought the trial duration.   The occurrence of adverse 
events and complaints will be assessed at each study visit and reported to AMO 
according to Section 12 Adverse Events and Product Complaints.  Additionally, AMO will 
monitor incoming data following the procedures outlined in Section 16, Monitoring.  The 
Medical Monitor will ensure subjects are not exposed to additional risks by monitoring 

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serious adverse events, device-related adverse events, and device-deficiencies that 
could have led to serious adverse events (Section 16.3, Medical Oversight).  
POTENTIAL BENEFITS 
The clinical performance of the TECNIS Toric IOL, Models ZCT450, ZCT525 and 
ZCT600 are expected to be similar to the TECNIS Toric IOL, Models ZCT300, ZCT375 
and ZCT400 with respect to providing good uncorrected distance vision, reduction in 
residual refractive cylinder, and increased spectacle independence for distance; 
however, the extended cylinder range will allow patients with higher preoperative corneal 
astigmatism access to the  same benefits as those with lower preoperative corneal 
astigmatism.  
CONCLUSION 
The hazards/risks associated with the TECNIS Toric IOL, Models ZCT450, ZCT525 and 
ZCT600 are acceptable and within those of AMO’s other Toric IOLs. The potential 
clinical benefits of these lenses outweigh the residual risks when the device is used as 
intended.  
19. RECORDS RETENTION 
All study-related correspondence, subject records, consent forms, Authorization for 
Use/Disclosure of Health Information Forms or similar medical treatment privacy law 
documentation, records of the distribution and use of all study products, and an 
electronic copy of the completed case report forms should be maintained by the 
investigator.   
The investigator must maintain and have access to the following essential documents 
until notified by the Sponsor.   Note:  This may be for a minimum of 15 years after 
completion of the study unless country-specific requirements are longer.  AMO requires 
notification if the investigator wishes to relinquish ownership of the data so that mutually 
agreed-upon arrangements can be made for transfer of ownership to a suitably qualified, 
responsible person. 
• 
All case report forms 
• 
All adverse event information (adverse event forms, follow-up letters, etc.) 
• 
IRB and regulatory approval documentation 
• 
Study correspondence  
• 
Study agreements 
• 
Site visit documentation 
• 
Protocol(s) and the reason for any deviations from the protocol 
• 
Subject log(s) 

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• 
Directions for Use 
• 
Completed subject informed consent forms and medical privacy forms (e.g., 
Authorization for Use/Disclosure of Health information or equivalent documentation 
necessary to comply with applicable privacy laws pertaining to medical treatment in 
the governing countries) 
• 
Subject medical chart/clinic notes 
20.  TERMINATION OF THE INVESTIGATION 
The clinical investigation will be suspended in the event of high levels of complications 
and/or adverse events occur that are unexpected in nature and/or severity and are 
possibly related to use of the study device.  The clinical investigation may be suspended 
if the Medical Monitor or IRB, upon review and evaluation of the clinical data, finds 
unacceptable clinical performance or the level of single or total complications and/or 
adverse events unacceptable for continuation of the investigation. 
If causality is shown not to be related to the study device, the study may be resumed in 
accordance with the IRB and regulations of the FDA.  The study will be terminated if 
causality is shown to be related to the study device. 
Additionally, the investigator, or AMO, may stop a subject’s participation at any time.  
AMO may also stop the study at any time for reasons it determines appropriate.  
However, no suspension of the study would be made to disadvantage the study 
subjects.  Following suspension of the study for any reason, all study subjects who have 
already received treatment would continue to be followed through completion of the 
study visit schedule. 
20.1 STATISTICAL METHODS 
This section highlights the analyses to be performed for key  study endpoints.  The 
6-month postoperative visit is the critical analysis time point for all endpoints.  
Descriptive statistics will typically include mean, standard deviation, minimum, maximum 
for continuous data with frequency and proportion reported for categorical data.    
20.2  ANALYSIS POPULATION 
For the primary endpoint and most visual distortion endpoints, the primary analysis 
population will be all bilaterally implanted subjects having available data at the 6-month 
visit.  Data will also be reported for all subjects including bilateral subjects and those with 
only one eye implanted (having a phakic lens, a cataract or other IOL in the fellow eye). 
Data will also be reported by IOL group.  If a subject does not have overall severe visual 
distortion data available at the 6-month visit (or had a repositioning procedure or IOL 
removal performed)  then data for this endpoint will be carried forward from the most 
recent visit (for general missing data) or the visit with data taken prior to the IOL 

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repositioning or removal.  If a subject had an IOL repositioning/removal and no 
questionnaire data prior to the procedure, then the subject will be considered to have 
had a severe visual distortion for this endpoint.  An additional analysis will be performed 
for the primary endpoint using multiple imputation techniques for those with no 
questionnaire data available.  Sensitivity analyses such as worst-case and best-case will 
also be performed.  
Refraction, visual acuity, medical/lens findings, axis evaluation and adverse events will 
be reported for primary eyes (those having the higher cylinder IOL or the first eye 
implanted if the same IOL is implanted in both eyes) and fellow eyes.  Data will be 
reported separately for ZCT450-ZCT600 eyes and ZCT 300-ZCT400 eyes.  
20.3 PRIMARY ENDPOINT 
The primary endpoint for this study is the rate of severe visual distortions (under overall 
circumstances) as measured by the 5  visual distortion items of interest in bilateral 
subjects at 6 months.  The frequency, proportion and a two-sided 95% confidence 
interval will be reported for this endpoint.  The frequency and proportion of subjects 
reporting one or more of these items as severe will be used to determine the rate of 
severe distortions. 
20.4 OTHER ENDPOINTS 
The frequency and proportion of subjects with each response will be reported for the 
individual visual distortion items on the visual distortion questionnaire for overall, with 
and without correction.   
To evaluate if IOL axis misalignment changes are associated with severe visual 
distortions, descriptive statistics for IOL axis misalignment and mean difference between 
IOL axis marker location and postoperative steep keratometry meridian will be reported 
for subjects with and without severe visual distortions.  
Descriptive statistics will be reported for mean percent reduction in cylinder, refractive 
cylinder, cylinder vs intended cylinder, spherical equivalent and spherical equivalent vs 
intended. The frequency and proportion of eyes within 0.50 D and within 1.00 D of 
intended values will be reported for refractive cylinder and spherical equivalent. The 
frequency and proportion achieving each acuity level will be reported for monocular and 
binocular uncorrected and best corrected distance visual acuity.   
Enrollment data, demographic data, subject accountability data and operative 
complications/procedures will be reported using descriptive statistics. Visual distortion 
findings, adverse events and other key data will be reported at 1 year for subjects who 
experienced a repositioning procedure during the study or who were reported with 
severe visual distortions at the 6-month visit.  

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The frequency and proportion of subjects with medical/lens findings or adverse events 
will also be reported.  
20.5 INTERIM REPORTS 
Interim status study reports will be provided to FDA every 6 months for the first 2 years 
following FDA approval of the lens models (July 31, 2015) and annually thereafter, until 
completion of the post-approval study according to the guidance document entitled 
“Procedures for Handling Post-Approval Studies Imposed by PMA Order,” dated June 
15, 2009. 
A primary-analysis, 6-month study report will be provided to FDA approximately 
3 months following completion of the last 6-month study visit.  Any 1-year data collected 
to date will be included.   
A final study report will be provided to FDA approximately 3 months following completion 
of the last 1-year study visit.  Note that the primary-analysis, 6-month report and the final 
report may be submitted at the same time depending upon when the last 6-month and 
1-year exams are completed. 
Interim and final study reports will include general enrollment and accountability items 
including the number of active sites, the number of subjects enrolled, implanted and 
discontinued and the number of postoperative examinations completed.  Interim reports, 
will only include descriptive statistics (no hypothesis testing).  Additional specifics on 
interim report items include:  
• Summary of study progress milestones/timeline elements 
• Stratified subject accountability data 
• Explanation for any discontinued or lost to follow-up subjects, including deaths 
• Summary of safety and effectiveness data using descriptive statistics of study 
results as of report period  
• Rationale for not meeting study milestones/timeline with a revised study 
timeline, as applicable 
• Revised reporting schedule with rationale for revision, as applicable 
 
20.6 SAMPLE SIZE CALCULATIONS 
With 80 subjects and a rate of 0.025 for severe visual distortions, this study has 86% 
probability of achieving a half-width of 0.05 for a 95% confidence interval for the rate of 
severe visual distortions. 

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APPENDIX A   SUMMARY OF PROCEDURES REQUIRED AT EACH VISIT 
 
  
 
Examination 
X= To be performed 
A= To be performed if a visual distortion is 
spontaneously reported prior to 6 month exam or 
prior to a required IOL repositioning (adverse 
event) 
B=To be performed if a subject reports a severe 
visual distortion or experiences a serious or 
device-related adverse event at this visit. 
O = Only if medically indicated 
Preoperative 
Both eyes 
Op 1 
1st eye 
Op 2 
2nd eye 
Unscheduled 
Visit  
1 Month 
Both eyes 
6 Months 
Both eyes 
1 Yeara 
Both eyes  
Ocular history, inclusion/exclusion criteria 
X 
 
 
 
 
 
 
Informed consent 
X 
 
 
 
 
 
 
Potential visual acuity  
X 
 
 
 
 
 
 
Targeted refraction/Targeted cylinder/IOL power 
calculationsb/axial length  
X 
 
 
 
 
 
 
Lens power/serial number/operative procedures 
 
X 
X 
 
 
 
 
UCDVA-photopic, monocular (Snellen) 
X 
 
 
B 
X 
X 
X 
UCDVA-photopic, binocular (Snellen)  
 
 
 
B 
X 
X 
X 
Manifest refraction (Snellen) 
X 
 
 
B 
X  
X 
X 
BCDVA-photopic, monocular (Snellen) 
X 
 
 
B 
X 
X 
X 
BCDVA-photopic, binocular (Snellen) 
 
 
 
B 
 X 
X 
X 
Offer spectacle and/or contact lens prescription        
 
 
 
 
X 
 
 
Keratometry 
X 
 
 
A/B 
A 
X 
X 
Intraocular pressure 
X 
 
 
B 
X 
X 
X 
Biomicroscopic slit-lamp exam
c  
 
X 
 
 
B 
X 
X 
X 
Toric IOL axis measurement at dilated slit-lamp exam  
 
 
 
A 
A 
X 
X 
Dilated fundus exam  
X 
 
 
O 
O 
O 
O 
Adverse events 
 
X 
X 
X 
X 
X 
X 
Ocular medications 
X 
 
 
X 
X 
X 
X 
Subject questionnaire   
X 
 
 
A  
A 
X 
X 
a  Examination at 1 year is to be conducted ONLY if a subject reported a severe visual distortion at 6 months or if the subject experienced an IOL repositioning procedure (due to IOL 
misalignment) during the study.   
b   Includes documentation of toric IOL calculations showing chosen ZCT for each eye and targeted cylinder outcome 
c  Includes determination of medical and lens findings/complications, including lens rotation 

ABBOTT MEDICAL OPTICS I
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APPENDIX B   TORIC IOL AXIS MEASUREMENT AT SLIT LAMP 
All investigative sites will be equipped with slit lamps that fulfill the following 
requirements: 
1) The slit lamp is capable of producing a narrow and long slit-lamp beam, 
2) the slit lamp allows 180° rotation of the slit-lamp beam and  
3) the slit lamp can be fitted with an angular scale with markers which allow for 
estimation of axis measurement to within 1° as measured by the slit-lamp beam.  
 
Upon installation of the angular scale and leveling of the slit lamp, the angular scale will 
be calibrated with a spirit level to ensure that the scale is at 90° for vertical slit-beam 
position and 0°/180° for the horizontal slit beam position. (A.N. Mukherjee, C. So, 
V. Kumar. “Clinical and experimental validation of a slit lamp modification to measure 
toric lens position,” Contact Lens & Anterior Eye, 34 (2011) 111-113)  
 
The following instructions are to be followed for the measurement of the toric IOL axis in 
both eyes. 
 
1. Dilate each eye with 2.5% phenylephrine prior to measurement.  Tropicamide 
(1%) may be used in addition to achieve adequate dilation for visualization of the 
axis orientation marks.  
2. Allow sufficient time to achieve adequate pupillary dilation to facilitate direct 
visualization of alignment marks. 
3. At the slit lamp, adjust the slit-lamp beam to be as narrow and as long as 
possible and align the beam with at least one of the four axis orientation marks 
(4.5, 5.0, 5.5 and 6.0 mm diameter) on each side of the toric IOL.  
a. It is important to align the beam with the orientation marks on both sides 
for an accurate measurement.  If both sides are not visible in the slit lamp, 
align the beam with at least three axis orientation marks from the visible 
side of the IOL.  
b. Ensure the subject’s head is oriented vertically in the slit lamp with proper 
head position and alignment of the eye with the slit lamp.  
4. Based on alignment of the narrowed slit-lamp beam with the toric IOL axis 
orientation marks, read the angle from the angular scale on the slit lamp.  
5. Record this angle in degrees for each eye on the appropriate postoperative case 
report form. 

ABBOTT MEDICAL OPTICS I
NC.
  
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                                            PR/TIOL-204-EPAS 
 
APPENDIX C   SLIT-LAMP EXAM RATINGS 
A.  Ratings of Aqueous Cells and Flare 
For consistency across study sites, the SUN (Standardization of Uveitis Nomenclature) 
Working Group Grading Scheme is to be used for grading of anterior chamber cells and 
flare as reported in: Standardization of uveitis nomenclature for reporting clinical data.  
Results of the first international workshop; The standardization of uveitis nomenclature 
(SUN) working group.  Am J Ophthalmol 2005;140:509-516. 
CELLS 
Grade 
Cells in Field 
(Field is a 1x1 mm slit beam) 
0 
<1 
0.5+ 
1 - 5 
1+ 
6 - 15 
2+ 
16 - 25 
3+ 
26 - 50 
4+ 
>50 
 
FLARE 
Grade 
Description 
0 
None 
1+ 
Faint 
2+ 
Moderate (iris and lens details clear) 
3+ 
Marked (iris and lens details hazy) 
4+ 
Intense (fibrin or plastic aqueous) 
B.  Ratings of Corneal Edema 
Corneal edema should be classified according to the haziness of the epithelium, the 
number of microcysts observed, and the clouding of the stroma. 
Amount 
Grade 
Description 
None 
0 
Normal transparency: 
a. No epithelial or sub-epithelial haziness 
b. No microcysts 
c. No stromal cloudiness 
Trace 
+1 
a. Barely discernible localized epithelial or sub-epithelial haziness, and/or 
b. 1 to 20 microcysts, and/or 
c. Barely discernible localized stromal cloudiness 
Mild 
+2 
a. Faint but definite localized or generalized epithelial, sub-epithelial or 
stromal haziness/cloudiness, and/or 
b. 21-50 microcysts 
Moderate 
+3 
a. Significant localized or generalized epithelial, sub-epithelial or stromal 
haziness/cloudiness and/or 
b. 51-100 microcysts 
Severe 
+4 
a. Definite widespread epithelial or stromal cloudiness, giving dull glass 
appearance to cornea or numerous coalescent bullae (please note the 
number and location of bullae), and/or 
b. >100 microcysts or bullae, and/or 
c. Numerous striae (please note the number and location of striae or folds) 

ABBOTT MEDICAL OPTICS I
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C.  Posterior Capsule Striae Grading Scale 
The following five-point grading scale is to be used for rating striae in the posterior 
capsule: 
Amount 
Grade Description 
None 
0 
None 
Trace 
+1 
One detectable, barely noticeable striae 
Mild 
+2 
One or two prominent striae 
Moderate 
+3 
Three or more prominent striae, but visibility of retina is 
not impacted 
Severe 
+4 
Three or more prominent striae affecting visualization of 
retina 
 
D.  Posterior Capsule Opacification Grading Scale 
Below is the five-point grading scale to be used for PCO determination: 
Amount 
Grade Description 
None 
0 
Normal posterior capsule with no area of opacity.  Red reflex 
bright. 
Trace 
+1 
Some loss of transparency involving the posterior capsule.  
Red reflex fairly bright 
Mild 
+2 
Mild loss of transparency with cloudiness extending through 
most of the posterior capsule.  There may be a few Elschnig’s 
pearls in the posterior capsule.  Red reflex mildly diminished. 
Moderate 
+3 
Moderate loss of transparency with difficulty visualizing the 
retina.  There may be multiple Elschnig’s pearls in the 
posterior capsule.  Red reflex markedly diminished. 
Severe 
+4 
Posterior capsule very opaque with inability to view the retina.  
The posterior capsule may have confluent Elschnig’s pearls 
and fibrous scarring.  Red reflex barely visible. 
 
E.  IOL Glistenings  
Use the following scale to grade IOL glistenings, using a slit beam 2.0 mm wide and 
10.0 mm long: 
Amount 
Grade 
Description 
None 
0 
No glistenings visible 
Rare 
+0.5 
<10 glistenings visible 
Trace 
+1 
10-19 glistenings visible 
Mild 
+2 
20-29 glistenings visible 
Moderate 
+3 
30-39 glistenings visible 
Severe 
+4 
≥ 40 glistenings visible