BEUDAMED
    FDA Recall Terminated

    Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.

    Recall: Z-1091-03 · Initiated July 22, 2003

    Recall

    Recall Number
    Z-1091-03
    Event Number
    26795
    Firm
    Coopervision Inc
    FEI Number
    1314956
    Product Code
    LPL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 22, 2003
    Posted
    August 7, 2003
    Terminated
    February 13, 2004
    Address
    711 North Road, Scottsville, NY, 14643

    Description

    Frequency 55 Toric (methafilcon B), flexible wear contact lenses (tinted). Responsible firms on the label: CooperVision ** Hamble, SO31 4RF, UK ** Scottsville, NY 14546.

    Reason

    Mislabeled with incorrect sphere power.

    Action

    Customers notified via telephone on 7/22/03.

    Distribution

    Nationwide. 33 eye care practitioners in the following states: AR, AL, CA, DE, FL, GA, IA, KS, MI, MA, NJ, NY, NC, OH, OK, PA, TX, UT, VA, and WI. Lenses were also shipped to Coopervision affiliates in the United Kingdom and Canada.

    Quantity

    152 lenses