BEUDAMED
    FDA Recall Terminated

    Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.

    Recall: Z-1022-2007 · Initiated June 8, 2007

    Recall

    Recall Number
    Z-1022-2007
    Event Number
    38230
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HNO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 8, 2007
    Posted
    August 2, 2007
    Terminated
    April 28, 2009
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Zyoptix XP Epi Head, packaged 1 per container, Cat. #ZXP32040, packaged nonsterile and reuseable. Ophthalmic surgical accessory. NOTE: The label only names the product as Zyoptix XP Microkeratome. It does not reference the product as an Epi Head The product is labeled as Manufacturer: Bausch & Lomb Incorporated, Rochester, NY. The Epi Head is used as an accessory to the Zyoptix XP Microkeratome, which is not under recall.

    Reason

    Reports have been received of stromal incursions after use of the product.

    Action

    The firm notified their customers via telephone between 6/8-12/07. During the call, the customer was informed reports had been received of stromal incursions and they were to quit using the product and return it.

    Distribution

    Distribution was limited to "key" physicians in MN, SC, MD, and NJ. Foreign distribution was made to the firm's entities in The Netherlands, Singapore, Mexico, Canada, Hong Kong, and India.

    Quantity

    29 Epi Heads