BEUDAMED
    FDA Enforcement Class II Terminated

    Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

    Recall: Z-0983-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0983-2017
    Event ID
    75915
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 18, 2017
    Initiation Date
    October 12, 2016
    Classification Date
    January 9, 2017
    Termination Date
    July 14, 2017
    Address
    1501 Graves Mill Rd, Lynchburg, VA, 24502-4328, United States

    Description

    Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient

    Reason

    According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging operator notified his supervisor he had not placed the operating instruction into the last repackaging of SKU 0816 C (Pterygium Burr Medium Diamond). Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction. Therefore Bausch & Lomb is proposing a Field Correction to provide customer purchasing product from April 30, 2012 to June 20, 2016 with the current operating instruction.

    Code Info

    LOT #(s) AND EXPIRATION DATES, SERIAL #(s), ORDER #, or OTHER IDENTIFICATION #(s): SKU E0815 A, SKU E0815 B, SKU E0815 0.5, SKU E0815 1.0 and SKU E0816 C

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    2487 units Domestic (USA), 1,211 units Foreign (outside USA)