BEUDAMED
    FDA Enforcement Class II Terminated

    Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.

    Recall: Z-3266-2018 · Reported October 3, 2018

    Enforcement

    Recall Number
    Z-3266-2018
    Event ID
    80837
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bausch & Lomb Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 3, 2018
    Initiation Date
    August 8, 2018
    Classification Date
    September 27, 2018
    Termination Date
    August 28, 2019
    Address
    3365 Tree Court Industrial Blvd, Saint Louis, MO, 63122-6615, United States

    Description

    Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.

    Reason

    The back cap separates from the body of the vitrectomy cutter.

    Code Info

    Lot numbers W0861, Exp. 6/4/2019, and W1115, exp. 7/5/2019, UDI 00757770059447.

    Distribution

    Distribution was made to AL, AZ, CA, CO, FL, GA, HI, IL, IN, KS, KY, MA, ME, MO, MT, NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, and WV. There was government distribution but no military distribution. Foreign distribution was made to Russia, Romania, Poland, The Netherlands, Jordan, Italy, Israel, Switzerland, Hungary, Greece, Guadeloupe, Great Britain, France, Spain, Singapore, Malaysia, and Thailand.

    Quantity

    16 cases