BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Stellaris Vision Enhancement System.

    Recall: Z-1664-2010 · Initiated January 15, 2010

    Recall

    Recall Number
    Z-1664-2010
    Event Number
    54268
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    NFJ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 15, 2010
    Posted
    May 26, 2010
    Terminated
    May 17, 2013
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb Stellaris Vision Enhancement System.

    Reason

    The AC power cords used on these products are subject to an FDA Alert -- Safety Investigation of Certain Medical Device Power Cords: Initial Communication, Date Issued: October 19, 2009.

    Action

    A "URGENT: POWER CORD RECALL" letter and copies of the FDA Alert dated Oct. 19, 2009 were sent to all customers on or about Jan. 15, 2010, by Stericycle, a recall notification service. The letter describes the product, problem and actions to be taken by the customers as well as FDA's recommendations and actions. The customers were made aware of the FDA Alert concerning the AC power cords and notified that these power cords were used in the devices. They were requested to inspect the power cords for damage and notify the recalling firm if damage is noted or if they have experienced sparking, charring, or firing from the power cords and/or cracking or failure of the prongs. In the absence of those conditions, customers were given the option of returning the power cord for replacement and/or during the regularly scheduled servicing of the device. If you would like a new power cord, please contact Customer Service at 1-800-338-2020 for a free replacement.

    Distribution

    Worldwide distribution: United States & Puerto Rico; Venezuela, India, Trinidad and Tobago, Colombia, Sri Lanka, Hong Kong, Vietnam, and Peru.

    Quantity

    Quantity never provided by the firm