BEUDAMED
    FDA Recall Terminated

    FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).

    Recall: Z-0787-03 · Initiated January 17, 2003

    Recall

    Recall Number
    Z-0787-03
    Event Number
    26077
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 17, 2003
    Posted
    May 1, 2003
    Terminated
    May 1, 2003
    Address
    11440 Johns Creek Parkway, Duluth, GA, 30097

    Description

    FreshLook Colors (phemfilcon A), 7-day Extended wear soft (hydrophilic) contact lens, Violet, SPH -0.75, Lot 064429, 2006-11, BC: Median DIA: 14-5, Rx only, CIBA Vision Corp., Duluth, GA 30097, USA. The product was distributed in multi-packs (cartons of six lenses each).

    Reason

    FreshLook 'Colors' contact lenses were incorrectly packaged into a FreshLook 'Colorblends' carton.

    Action

    Consignees were notified via letter on January 17, 2003. They were advised to return any of the affected lot to CIBA Vision for replacement.

    Distribution

    The product was distribured to wholesalers located in AL, CA, CO, FL, GA, IA, IL, IN, MA, MO, NC, NJ, NY, OH, OK, OR, PA, TX, UT, WA, and WI.

    Quantity

    309/six pack cartons