BEUDAMED
    FDA Recall Terminated

    SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and (2) ONEVUE 55 toric (methafilcon A) flexible wear. Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.

    Recall: Z-0978-03 · Initiated June 25, 2003

    Recall

    Recall Number
    Z-0978-03
    Event Number
    26532
    Firm
    Coopervision Inc
    FEI Number
    1314956
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 25, 2003
    Posted
    July 3, 2003
    Terminated
    April 11, 2005
    Address
    711 North Road, Scottsville, NY, 14643

    Description

    SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and (2) ONEVUE 55 toric (methafilcon A) flexible wear. Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.

    Reason

    The actual sphere power of the lens is lower than the labeled value.

    Action

    Letters dated June 24, 2003 issued to eye care practitioners and distributors with instructions to return lenses to Coopervision. Distributors also instructed to notify their customers.

    Distribution

    Coopervision, Scottsville, NY is recalling from domestic customers nationwide. Product in Canada and Europe being recalled by affiliate in Europe.

    Quantity

    23,762 6-packs / 76,748 singles (trial lenses)