BEUDAMED
    FDA Recall Terminated

    Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''.

    Recall: Z-0164-05 · Initiated October 13, 2004

    Recall

    Recall Number
    Z-0164-05
    Event Number
    30238
    FEI Number
    3003106412
    Product Code
    MVN
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 13, 2004
    Posted
    November 3, 2004
    Terminated
    February 25, 2005
    Address
    1-800 Contacts Inc. 66 Wadsworth Park Dr, Draper, UT, 84020-7942

    Description

    Counterfeit contact lenses labeled as: 'CooperVision Proclear compatibles (omafilcon A)'. Labeling on outer box reads in part: 'CooperVision proclear compatibles (omafilcon A) ***Norfolk, VA *** MADE IN USA ** Tinted soft contact lenses *** in a buffered 0.9% saline solution***''.

    Reason

    Identified lots of Proclear Compatible contact lenses are counterfeit and may not be sterile.

    Action

    Identified lots of CooperVision Proclear Compatibles contact lenses are counterfeit and non-sterile.

    Distribution

    Product distributed to customers nationwide and internationally. Product distributed in US and to Canada, England, New Zealand, New Foundland, British columbia,Guam, Egypt, Greece, Japan, Ireland and Autralia.

    Quantity

    82,268