BEUDAMED
    FDA Recall Terminated

    Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.

    Recall: Z-1716-2010 · Initiated January 8, 2010

    Recall

    Recall Number
    Z-1716-2010
    Event Number
    54200
    Firm
    Bausch & Lomb Inc
    FEI Number
    1317628
    Product Code
    HQE
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    January 8, 2010
    Posted
    May 28, 2010
    Terminated
    April 2, 2012
    Address
    1400 North Goodman Street, Rochester, NY, 14609-3547

    Description

    Bausch & Lomb Stellaris Basic AFS Phaco Pack, Model BL5121, 6 packs/box, RX, Sterile. The firm name on the label is Bausch & Lomb Incorporated, Rochester, NY. The plastic needle wrench contained in the package is used to tighten or untighten phacoemulsification needles on phaco handpieces of the Millenium and Stellaris machines. The Millenium and Stellaris are used by ophthalmic surgeons to emulsify and aspirate cataract material during cataract surgery, to cut and aspirate vitreous material during anterior and posterior segment surgery, and to drive a variety of handpieces during posterior segment surgery.

    Reason

    Users may incorrectly assemble the plastic needle wrench to the phacoemulsification needle resulting in the generation of plastic particulate

    Action

    The recalling firm, Bausch & Lomb, issued an "URGENT: PHACO NEEDLE WRENCH CORRECTION" letter dated January 7, 2010, via first class mail to all customers. The letter describes the product, problem and actions to be taken by the customers. The letter also provides instructions and pictorial representations demonstrating proper seating of the needle to the wrench as well as a description of the appropriate force to tighten the needle to the handpiece. The customers were instructed to please read and follow the attached instructions entitled (Potential for Particulate Matter in the eye and proper assembly and use of needle wrench) and fill-out and return/fax at 949-716-8362, the Bausch & Lomb Phacoemulsification Needle Wrench Particulate correction form. If you have any questions or concerns please contact, Chris Willis or Stephen Haight at 1-800-387-3284.

    Distribution

    Worldwide distribution: USA and Germany, France, Italy, Norway, Sweden, Finland, The Netherlands, Switzerland, U.K., Austria, Luxembourg, Ireland, Hong Kong, New Zealand, India, Australia, and Japan.

    Quantity

    1,198/6-pack boxes