BEUDAMED
    FDA Recall Terminated

    TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

    Recall: Z-0237-2016 · Initiated September 29, 2015

    Recall

    Recall Number
    Z-0237-2016
    Event Number
    72434
    Firm
    Tekia, Inc.
    FEI Number
    3002023310
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 29, 2015
    Posted
    November 6, 2015
    Terminated
    December 3, 2015
    Address
    17 Hammond, Ste 414, Irvine, CA, 92618-1635

    Description

    TEKIA Single Piece Hydrophilic Acrylic Intraocular Lenses, Model 811

    Reason

    Tekia is recalling the Single Piece Hydrophillic Acrylic Intraocular Lenses (IOLs) because they may be labeled with the incorrect diopter power.

    Action

    Tekia sent an Field Safety Notice dated September 29, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers were advised that Tekia is recalling a limited a number of Single Piece Hydrophilic Acrylic IOLs. If the customer has any questions, the customer is instructed to contact a TEKIA Customer Service or QA Representative at (949) 699-1300. Customers with product complaints or adverse events regarding the use of Single Piece Hydrophilic Acrylic IOLs are instructed to inform TEKIA by phone, email, or fax.

    Distribution

    Internationally to Vietnam.

    Quantity

    50 units