BEUDAMED
    FDA Recall Terminated

    AcrySof ReSTOR Intraocular Lens

    Recall: Z-0429-2007 · Initiated December 14, 2006

    Recall

    Recall Number
    Z-0429-2007
    Event Number
    37009
    Firm
    Alcon Laboratories, Inc
    FEI Number
    1610287
    Product Code
    MFK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2006
    Posted
    February 15, 2007
    Terminated
    April 9, 2008
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2001

    Description

    AcrySof ReSTOR Intraocular Lens

    Reason

    Intraocular lenses exposed to extreme temperatures while in storage.

    Action

    The recall of the fifteen re-shipped lenses was conducted by telephone calls to the nine customers that had received the lenses. These calls were made on December 14, 2006.

    Distribution

    Nationwide.

    Quantity

    4 units