BEUDAMED
    FDA Recall Terminated

    Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses.

    Recall: Z-1234-03 · Initiated August 13, 2003

    Recall

    Recall Number
    Z-1234-03
    Event Number
    26932
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 13, 2003
    Posted
    September 13, 2003
    Terminated
    January 28, 2005
    Address
    11440 Johns Creek Parkway, Duluth, GA, 30097

    Description

    Quick Care Starting Solution. The product is used for cleaning and disinfection of soft (hydrophilic) contact lenses.

    Reason

    Investigation has determined that the concentration of the isopropyl alcohol (IPA) decreased over time and may fall below specifications prior to reaching the expiration date.

    Action

    The consignees were notified of the recall by letter on August 13, 2003 asking for return of the product.

    Distribution

    CA, CT, FL, GA, IA, KS, MI, MN, OH, and WI

    Quantity

    2,136 units