BEUDAMED
    FDA Recall Terminated

    Frames Direct Prescription Spectacle Lenses included in the frame brands

    Recall: Z-2063-2020 · Initiated March 18, 2020

    Recall

    Recall Number
    Z-2063-2020
    Event Number
    85484
    Firm
    Frames Direct
    FEI Number
    3010951083
    Product Code
    HQG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 18, 2020
    Terminated
    June 14, 2022
    Address
    2801 S Interstate 35, Ste 170, Austin, TX, 78741-5516

    Description

    Frames Direct Prescription Spectacle Lenses included in the frame brands

    Reason

    The firm has become aware through their optical laboratory supplier that prescription spectacle lenses within various frames failed to meet safety specification for shatter resistance. This could result in cracked or broken lenses.

    Action

    On 03/24/20, FramesDirect.com sent a "Urgent Medical Device recall letter via certified mail to affected consignees. The firm also emailed and phoned each affected consignee on 3/20/20. In addition to informing consignees about the recalled spectacle lenses, they asked consignees take the following action: Please discontinue use of these eyeglasses immediately and return them as soon as possible using the prepaid UPS label enclosed. The order numbers listed below have been included in this urgent medical device recall.

    Distribution

    US: Alabama,Arizona,California,Colorado,Florida,Georgia,Hawaii,Idaho,Illinois,Indiana,Kansas,Kentucky,Louisiana,Maine,Maryland,Massachusetts,Michigan,Mississippi,Missouri,Montana,Nevada,New Jersey,New Mexico,New York,North Carolina,Ohio,Oklahoma,Oregon,Pennsylvania,Puerto Rico,South Carolina,Texas,Utah,Virginia,Washington,Wisconsin OUS: Canada & Germany

    Quantity

    87 pair