BEUDAMED
    FDA Recall Terminated

    Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106

    Recall: Z-0542-2010 · Initiated November 24, 2009

    Recall

    Recall Number
    Z-0542-2010
    Event Number
    53946
    FEI Number
    1035170
    Product Code
    HQY
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    November 24, 2009
    Posted
    December 22, 2009
    Terminated
    October 27, 2010
    Address
    Luxottica 4800 Luxottica Place, Mason, OH, 45040

    Description

    Polycarbonate prescription lenses (single vision, progressive, and trifocal) SKU #'s: 3703154, 4286102, 4286103, 4286104 and 4286106

    Reason

    The lenses made for sunglass frames (Liberty Sport Slam or MaxMorpheus) do not meet the lens thickness specification established by the frame manufacturer. The lens thickness range from 1.0 to 1.9 millimeters instead of the required 2.0 millimeter minimum. There is a potential risk that the lenses could break or disengage from the frame in the event of an impact.

    Action

    On 11/24/2009 the firm sent recall notification letters to their customers indicating the problem with the lenses. they instructed their customers return the product to the place of purchase for replacement or refund. Questions are directed to the firm at 1-877-488-2407 from 8:00 a.m. to 5:00 p.m. ET.

    Distribution

    Product was distributed to the following states: AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MT, NC, NH, NJ, NM, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, & WV.

    Quantity

    276 polycarbonate prescription lenses (138 pairs of lenses)