BEUDAMED
    FDA Recall Terminated

    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

    Recall: Z-1688-2016 · Initiated April 14, 2016

    Recall

    Recall Number
    Z-1688-2016
    Event Number
    73883
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    OOE
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    April 14, 2016
    Terminated
    October 20, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    LenSx Laser System. Indicated for use in patients undergoing cataract surgery and refractive surgery.

    Reason

    Alcon is conducting a voluntary recall of all LenSx Lasers with Corneal Flap Capability after receiving reports concerning incomplete corneal flap creation, which manifests as an un-dissected area(s) within the side cut.

    Action

    Recall notification letters were sent to consignees on April 14, 2016. The letter details precautions to be taken by the surgeon and requests the consignee sign and return an acknowledgement form.

    Distribution

    United States, Albania, Australia, Brazil, Chile, Costa Rica, Czech Republic, France, Germany, Greece, Hungary, India, Italy, Romania, Slovakia, Spain, Taiwan, Thailand, Turkey, UAE, Ukraine

    Quantity

    81 units