BEUDAMED
    FDA Recall 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 · Initiated October 12, 2016

    Recall

    Recall Number
    Z-0983-2017
    Event Number
    75915
    Firm
    Bausch & Lomb, Inc.
    FEI Number
    1000305478
    Product Code
    OHW
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 12, 2016
    Posted
    January 10, 2017
    Terminated
    July 14, 2017
    Address
    1501 Graves Mill Rd, Lynchburg, VA, 24502-4328

    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Further investigation found that repackaged Algerbrush-II and its accessories from April 30, 2012 to present, contained out of date operating instruction.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.

    Action

    Bausch + Lomb sent an Urgent Medical Device Voluntary Field Correction letter dated October 12, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. For questions contact Bausch + Lomb customer service at 1-800-338-2020

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

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