BEUDAMED
    FDA Recall Terminated

    Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.

    Recall: Z-1911-2009 · Initiated December 8, 2008

    Recall

    Recall Number
    Z-1911-2009
    Event Number
    52652
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HQL
    Status
    Terminated
    Root Cause
    Release of Material/Component prior to receiving test results
    Initiated
    December 8, 2008
    Posted
    September 9, 2009
    Terminated
    November 5, 2009
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Adapt AO, Akreos Advanced Optics Aspheric Lens. Bausch & Lomb Incorporated, Rochester, NY. Manufactured by Bausch & Lomb Incorporated, Clearwater, FL.

    Reason

    Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.

    Action

    All consignees were notified via phone, telefax and letter. Products are to be returned to Bausch & Lomb's European Logistics Center (ELC) for destruction. Direct questions to Bausch and Lomb, Inc. by calling 1-585-338-6612.

    Distribution

    Foreign Distribution only -- Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom.

    Quantity

    158