BEUDAMED
    FDA Enforcement Class II 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 · Reported March 25, 2015

    Enforcement

    Recall Number
    Z-1268-2015
    Event ID
    70348
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Med-logics Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2015
    Initiation Date
    January 13, 2015
    Classification Date
    March 13, 2015
    Termination Date
    October 28, 2015
    Address
    1627 Enterprise St, Athens, TX, 75751-8839, United States

    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.

    Code Info

    Lot 1490288

    Distribution

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

    Quantity

    360 units