BEUDAMED
    FDA Recall Terminated

    ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.

    Recall: Z-1268-2015 · Initiated January 13, 2015

    Recall

    Recall Number
    Z-1268-2015
    Event Number
    70348
    Firm
    Med-logics Inc
    FEI Number
    1000142667
    Product Code
    HNO
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 13, 2015
    Posted
    March 13, 2015
    Terminated
    October 28, 2015
    Address
    1627 Enterprise St, Athens, TX, 75751-8839

    Description

    ML 7090 Calibrated LASIK Blade (CLB); CLB CALIBRATED LASIK BLADE 10. ML 7090 Calibrated LASIK Blade (CLB) is to be used as replacement blades for the AMO Amadeus Microkeratome, to perform lamellar keratectomy procedures.

    Reason

    The ML 7090 Calibrated LASIK Blade (CLB) will not fit into the AMO Amadeus Metal Blade Holder.

    Action

    The firm notified their consignees by letter on 1/13/15, sent via FedEx. The US customers were instructed to return any remaining product to MED-LOGICS and complete the response form.

    Distribution

    Distributed in the states of CA, AL, GA, and TN, and the countries of Chile and Germany.

    Quantity

    360 units