BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery

    Recall: Z-3088-2011 · Initiated July 27, 2011

    Recall

    Recall Number
    Z-3088-2011
    Event Number
    59662
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 27, 2011
    Posted
    August 30, 2011
    Terminated
    June 21, 2013
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb Stellaris Basic Vacuum Phaco Pack, Ref: BL5111, packaged 6 units/case, RX, Sterile. Bausch & Lomb Incorporated, Rochester, NY For use with the Bausch & Lomb Stellaris Vision Enhancement System for the phacoemulsification of an opacified crystalline lens during anterior segment surgery

    Reason

    The aspiration channel on the affected vacuum cassettes may be blocked due to a molding malfunction

    Action

    Bausch & Lomb Inc. notified all affected customers by direct telephone contact on July 27, 2011 and a follow-up FAX or e-mail dated July 27, 2011 The letter included; affected product, problem, and requests customers return the product. An acknowledgement form was included to complete and return with the product. For question on this recall contact Bausch & Lomb at (949) 521-7895.

    Distribution

    Nationwide Distribution.

    Quantity

    229/6-unit cases