BEUDAMED
    FDA Recall Terminated

    Intralase FS Laser System. Laser Keratome

    Recall: Z-1124-03 · Initiated July 15, 2003

    Recall

    Recall Number
    Z-1124-03
    Event Number
    26826
    FEI Number
    3002930984
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 15, 2003
    Posted
    August 12, 2003
    Terminated
    December 2, 2004
    Address
    Intralase Corp 3, Morgan Irvine, CA, 926181916

    Description

    Intralase FS Laser System. Laser Keratome

    Reason

    Gantry moves toward patient when 'Home' button is used after procedure.

    Action

    Firm sent Safety Alert letters to customers on July 15, 2003 by registered mail instructing not to use the HOME button, including a 'Do Not Use' sticker for the machine and an addendum to the Operations Manual.

    Distribution

    Nationwide and Japan.

    Quantity

    70