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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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AcrySof IQ ReSTOR +3.0 Toric PAS

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Study Status Study Pending
Application Number P040020 S049/ PAS001
Date Current Protocol Accepted  
Study Name AcrySof IQ ReSTOR +3.0 Toric PAS
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Adult: >21

AcrySof IQ ReSTOR +3.0 Toric PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 06/22/2017 07/12/2017 Overdue/Received
one year report 12/22/2017 12/13/2017 On Time
18 month report 06/22/2018 06/19/2018 On Time
two year report 12/22/2018 12/18/2018 On Time
three year report 12/22/2019    
four year report 12/21/2020    
Final Report 04/21/2021    

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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