BEUDAMED
    FDA Recall Terminated

    Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).

    Recall: Z-2706-2011 · Initiated May 20, 2011

    Recall

    Recall Number
    Z-2706-2011
    Event Number
    59028
    Firm
    Staar Surgical Co.
    FEI Number
    2023826
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 20, 2011
    Posted
    June 29, 2011
    Terminated
    March 4, 2014
    Address
    1911 Walker Ave, Monrovia, CA, 91016-4846

    Description

    Brand Name STAAR Surgical Collamer Ultraviolet-Absorbing Posterior Chamber Single Piece Foldable Intraocular Lens Common Names Collamer single piece IOL Collamer plate haptic IOL The Device is intended to correct aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by cataract extraction. The Device is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).

    Reason

    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.

    Action

    Staar Surgical send out an URGENT - Medical Device Correction Notice to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to acknowledge receipt of the letter by signing, dating, and faxing the form to Staar Surgical. For any questions call (800) 292-7902, ext 2345.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of South Africa, Slovakia, Mexico, Hong Kong, and Sri Lanka

    Quantity

    16,750 devices distributed to the field