BEUDAMED
    FDA Recall 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 · Initiated August 8, 2018

    Recall

    Recall Number
    Z-3266-2018
    Event Number
    80837
    Firm
    Bausch & Lomb Inc
    FEI Number
    1920664
    Product Code
    HQE
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 8, 2018
    Terminated
    August 28, 2019
    Address
    3365 Tree Court Industrial Blvd, Saint Louis, MO, 63122-6615

    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.

    Action

    Recall letters flagged URGENT MEDICAL DEVICE VOLUNTARY RECALL dated 8/8/2018 were issued 8/8/2018 via certified mail return receipt to the U.S. consignees. Letters for foreign consignees were dated 8/7/2018 and were flagged URGENT FIELD SAFETY NOTICE.

    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