BEUDAMED
    FDA Recall Terminated

    Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight.

    Recall: Z-1568-2011 · Initiated June 30, 2010

    Recall

    Recall Number
    Z-1568-2011
    Event Number
    56120
    Firm
    Luxottica Optical Manufacturing
    FEI Number
    3008153912
    Product Code
    HQG
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2010
    Posted
    March 7, 2011
    Terminated
    September 19, 2012
    Address
    4000 Luxottica Place, Mason, OH, 45040

    Description

    Polycarbonate prescription single vision lenses for use in sport goggles. To be worn by a customer in a sport goggle frame to provide corrective refraction in accordance with the customer's prescription. Per the customer's request, some of the devices may also provide protection from bright sunlight.

    Reason

    The polycarbonate prescription lenses may not meet the frame manufacturer's minimum lens thickness specification of 2.0 millimeters. LNAD made the decision to remove these sport goggles from the market because of the potential risk that the lenses could break or disengage from the frame in the event of an impact.

    Action

    Luxottica Optical Manufacturing sent notification letters on June 30, 2010, to their customers informing them of the problem. Customers were instructed to complete the enclosed Sport Goggle Return Form, and to indicate whether they would like a replacement pair of goggles or a refund. Place the completed Sport Goggle Return Form and their sport goggles (without the sport goggle case) in the envelope provided and return it to the firm via the United States Postal Service. Customers were instructed not to return to the retail store where purchased. If customers were unable to return their sport goggles because they were lost or discarded, customers should complete the appropriate information on the Sport Goggle Return Form, being sure to indicate whether they would like a replacement pair of goggles or a refund, and then sign the form. Place the completed Sport Goggle Return Form in the envelope provided and return it to the firm via the United States Postal Service. For any questions, call 1-877-488-2407. They instructed their customers to return the product for replacement or refund.

    Distribution

    Worldwide Distribution - USA including the following states: AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV; and the country of Canada.

    Quantity

    2,916 individual lenses (1,458 pair of sport goggles)