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CustomFlex Artificial Iris

by Humanoptics AG

PMA P170039

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P170039↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP170039 Date30 May 2018ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Full name
CustomFlex ArtificialIris
Trade Name
CustomFlex Artificial Iris
Generic Name
Artificial iris
PMA Number
FDA Product Code
QBT
Device Class
Class III
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The CustomFlex Artificial Iris is a Class III medical device classified as an artificial iris, designed to replace a missing or damaged iris in patients with full or partial aniridia. It is intended for use in both pediatric and adult populations to restore iris function and improve visual outcomes in cases of congenital aniridia, acquired defects, or other associated conditions.

This device is supplied sterile and intended for single-use implantation. It is regulated under an FDA Premarket Approval (PMA) with approval number P170039, ensuring compliance with stringent safety and efficacy standards. The CustomFlex Artificial Iris is manufactured by Humanoptics AG and is available in sizes and configurations tailored to individual patient anatomy, as specified in the approved design.

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the CustomFlex Artificial Iris used for in clinical practice?

    The CustomFlex Artificial Iris is designed to replace a missing or damaged iris in patients with full or partial aniridia, a condition that can occur congenitally or be acquired. It is intended to restore iris function and improve visual outcomes for both pediatric and adult patients, addressing cases linked to congenital aniridia, acquired defects, or related conditions.

  • How is the CustomFlex Artificial Iris supplied and intended for use?

    The CustomFlex Artificial Iris is supplied sterile and is intended for single-use implantation only. This ensures patient safety by preventing cross-contamination and maintaining device integrity during surgical procedures.

  • Are there different sizes or configurations available for the CustomFlex Artificial Iris?

    Yes, the CustomFlex Artificial Iris is available in sizes and configurations tailored to individual patient anatomy. These variations are specified in the approved design to ensure proper fit and function during implantation.

  • How is the CustomFlex Artificial Iris regulated, and what does that mean for its use?

    The CustomFlex Artificial Iris is regulated under an FDA Premarket Approval (PMA) with approval number P170039. This means it has undergone rigorous review by the FDA to ensure safety, effectiveness, and compliance with regulatory standards before being authorized for use in clinical practice.

  • What should I consider regarding storage of the CustomFlex Artificial Iris before use?

    Since the CustomFlex Artificial Iris is supplied sterile and intended for single-use, it must be stored according to the manufacturer’s instructions to preserve sterility. Proper storage conditions—such as temperature, humidity, and protection from contamination—are critical to maintaining device integrity until implantation.