BEUDAMED
    FDA Recall Terminated

    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

    Recall: Z-0694-2020 · Initiated November 9, 2018

    Recall

    Recall Number
    Z-0694-2020
    Event Number
    83903
    Firm
    Tekia, Inc.
    FEI Number
    3002023310
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 9, 2018
    Terminated
    September 16, 2020
    Address
    17 Hammond, Ste 414, Irvine, CA, 92618-1635

    Description

    TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses, Diopter 15.0, Sterile. The firm name on the label is TEKIA, INC., Irvine, CA.

    Reason

    A limited number of lenses may be mislabeled with the incorrect diopter power.

    Action

    The recalling firm issued letters dated 11/9/2018 notifying the consignee to take the following actions: 1) to stop using the device and remove the product from inventory, 2) inform TEKIA by email ([email protected], [email protected]) within 3 working days of all the retrieved and already implanted Single Piece Hydrophilic Acrylic IOLs listed in the letter, including serial numbers, and 3) destroy the product once every affected IOL is removed out from your inventory and forward evidence of destruction with corresponding serial numbers by email ([email protected], [email protected]). If you have any questions, please contact a TEKIA Customer Service or QA Representative at (949)-699-1300.

    Distribution

    There was no U.S. distribution. Foreign distribution was made to Iran, Korea, Luxembourg, and Vietnam.

    Quantity

    81 IOLs were distributed but only 36 within expiry were recalled