BEUDAMED
    FDA Recall Terminated

    Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.

    Recall: Z-0703-03 · Initiated March 17, 2003

    Recall

    Recall Number
    Z-0703-03
    Event Number
    25796
    Firm
    Ciba Vision Corporation
    FEI Number
    1053053
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2003
    Posted
    April 1, 2003
    Terminated
    April 7, 2004
    Address
    11440 Johns Creek Parkway, Duluth, GA, 30097

    Description

    Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in mulitple glass vials.

    Reason

    The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.

    Action

    The recall is being conducted to the wholesale level. The firm began contacting consignees via traceable mail on/about 3/17/2003. Included was A Business Reply Form and pre-paid airbill to return the product currently in inventory and the completed form. All inventory and returned product will be destroyed.

    Distribution

    Nationwide, Canada and Puerto Rico.

    Quantity

    29,821 units