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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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PAS, Adult and Pediatric

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Study Status Protocol Overdue
Application Number P170039 / PAS001
Study Name PAS, Adult and Pediatric
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of this study is to evaluate the long term safety of the CustomFlex Artificial Iris in adults (up to 3 years) and pediatrics (up to 5 years) for the treatment of full or partial aniridia resulting from congenital and acquired iris defects, including but not limited to traumatic iris defects, traumatic mydriasis, and post inflammatory iris sequelae.

The applicant is conducting a continued follow-up of the premarket cohort (AI-001 study).

The continued follow-up study is a prospective, nonrandomized, multiple cohort, safety study in which the postoperative outcomes of the subjects are compared to their preoperative baseline.

Study Population Description The study population consists of adult and pediatric subjects who participated in the AI-001 IDE study for less than 36 months (adults) or less than 60 months (pediatrics).

Sample Size Up to 580 subjects enrolled in one of the previous AI-001 study cohorts (PMA, Compassionate Use, or Continued Access).
Data Collection Primary Safety Endpoint:

Device related adverse events at 12 months postoperatively should not exceed the threshold rates listed below:

Less than 5% of subjects should lose more than 2 lines of BSCVA that is device related and unresolved

Less than 5% of subjects should have BSCVA of worse than 20/40, if the preoperative BSCVA was 20/40 or better, and that is device related and unresolved.

Secondary Safety Outcomes:

In eyes where an IOL has been implanted concurrently:

Anisometropia <1%

Glare/halos <1%

Diplopia <1%

IOL removal or replacement due to lens power calculation error <1%

Other Outcomes:

Cumulative Surgery Related Adverse Events

Endothelial cell density (ECD) changes

Device malfunction or defects

Device related complications

Follow-up Visits and Length of Follow-up 3 years (adults) and 5 years (pediatrics)

PAS, Adult and Pediatric Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 11/28/2018 12/27/2018 Overdue/Received
one year report 05/30/2019 05/30/2019 On Time
18 month report 11/28/2019    
two year report 05/29/2020    
three year report 05/29/2021    
four yer report 05/29/2022    
five year report 05/29/2023    

Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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