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Collamer UV Absorbing Posterior Chamber Intraocular Lens

by Starr Surgical Co.

PMA P990013

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

5 closed

Documents

PMA P990013↗

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 NumberP990013 Date2 Apr 2000ApprovedStatusActive

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1747-2013 FDA Class II initiated 10 Jun 2013
    • Terminated Z-1746-2013 FDA Class II initiated 10 Jun 2013

    STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intraocular lenses due to the potential presence of glass particles in the storage vial.

    • Terminated Z-2706-2011 FDA Unclassified (pre-2012) initiated 20 May 2011

    The recall was initiated by Staar Surgical due to an error in the Directions for Use (DFU) for Staar Surgical's Collamer Ultraviolet Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens (Collamer IP IOL), also known as the nanoFLEX IOL. The Device Description erroneously indicates that the lens could be implanted in the ciliary sulcus.

    • Terminated Z-1037-04 FDA Unclassified (pre-2012) initiated 17 Jun 2004

    Mislabeled in part. Label set, patient chart labels, and patient ID card serial number did not match the IOL serial number.

    • Terminated Z-0539-04 FDA Unclassified (pre-2012) initiated 9 Feb 2004

    Risk of hyperopic refractive changes.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Trade Name
Collamer Ultraviolet Absorbing Posterior Chamber Intraocular Lens
Generic Name
intraocular lens
PMA Number
FDA Product Code
HQL
Device Class
Class III
Regulation
21 CFR Part 886.3600
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.

This device is an intraocular lens indicated for the correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction. The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis.

It is supplied as a sterile, single-use implantable device intended for use in ophthalmic surgical settings. The device holds FDA PMA approval (P990013) and is classified as a Class III medical device under regulation number 886.3600.

Other devices from Starr Surgical Co.

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 intended use of this intraocular lens?

    The lens is indicated for the correction of aphakia in persons 60 years of age or older who have undergone cataract removal via phacoemulsification, with implantation in the posterior chamber and capsular bag.

  • Who manufactures this device and what regulatory pathway was used?

    The device is manufactured by Starr Surgical Co. and received FDA Premarket Approval (PMA) under application number P990013, granted on April 2, 2000.

  • Is this lens reusable or single-use?

    The device is supplied as a sterile, single-use implant and is not intended for reuse.