BEUDAMED
    FDA Recall Terminated

    CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.

    Recall: Z-0793-2007 · Initiated April 30, 2007

    Recall

    Recall Number
    Z-0793-2007
    Event Number
    37854
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 30, 2007
    Posted
    May 9, 2007
    Terminated
    March 13, 2008
    Address
    11460 Johns Creek Pkwy, Duluth, GA, 30097-1518

    Description

    CIBASoft Visitint Soft Contact Lenses, SKU #749591001385, Power -6.50, Diameter 13.8, Base Curve, 8.9, Expiration 2011-10.

    Reason

    Base curve of the lenses do not meet specification.

    Action

    Consignees were contacted via traceable mail on 4/30/2007. The initial notification was sent to Eye Care Professionals. The firm subsequently identified one distributor and one retailer. The recall letter was revised and sent to these consignees on May 2, 2007. Specific return instructions were attached along with a Recall Tracking Form that was to be completed and returned to CIBA Vision. They were instructed to return any of the affected product on hand to CIBA Vision for replacement.

    Distribution

    Nationwide.

    Quantity

    22 lenses