BEUDAMED
    FDA Recall Terminated

    Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.

    Recall: Z-2012-2009 · Initiated April 20, 2009

    Recall

    Recall Number
    Z-2012-2009
    Event Number
    52828
    Firm
    Vistakon
    FEI Number
    1000222023
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2009
    Posted
    September 18, 2009
    Terminated
    October 1, 2009
    Address
    7500 Centurion Pkwy, Ste 100, Jacksonville, FL, 32256-0517

    Description

    Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process.

    Reason

    Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.

    Action

    Firm notified consignees by phone from April 7, 2009 to April 27, 2009. Firm requested product disposition. Direct questions about the recall to Vistakon by calling 1-904-443-1763.

    Distribution

    Nationwide.

    Quantity

    73