BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat. #MVS1011C-20g, Light Pipe (which is not under recall). These two products are packaged separately and are not bundled in any way. They are merely shipped at the same time. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.

    Recall: Z-0496-2007 · Initiated December 14, 2006

    Recall

    Recall Number
    Z-0496-2007
    Event Number
    36980
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HQE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 14, 2006
    Posted
    May 24, 2007
    Terminated
    April 7, 2009
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb Millennium 20 Ga. High Speed Posterior Vitrectomy Pack, Catalog #CX4920, containing 1/20-gauge high speed vitrectomy cutter as well as other accessories. Catalog #USSCX4920A is also included in the recall, which is used by customers for ordering only . There is no labeling associated with this catalog number. This catalog number is used for ordering Cat. #4920 along with Cat. #MVS1011C-20g, Light Pipe (which is not under recall). These two products are packaged separately and are not bundled in any way. They are merely shipped at the same time. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY.

    Reason

    The cutter tip could break during a procedure

    Action

    Recall letters were issued via e-mail to surgeons on 12/14/06 and via overnight mail on 12/14/06 to surgeons and operating room supervisors requesting immediate segregation and return of the product.

    Distribution

    Worldwide distribution ---- including USA and countries of Canada, China, Japan, Australia, Hong Kong, India, Malaysia, New Zealand, Singapore, Korea, Taiwan, Thailand, Argentina, Brazil, Mexico, and The Netherlands.

    Quantity

    Cat. CX4920 - 4,475 packs; and Cat. CX4920A - 40 packs