BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2481063 · Received March 2, 2012

    Report

    Report Number
    3008772169-2012-00009
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 10, 2012
    Report Date
    February 10, 2012
    Manufacturer
    ALCON LENSX LASERS INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE ENGINEER WAS DISPATCHED TO INVESTIGATE THE LASER SYSTEM. THE ENGINEER INSTALLED NEW BRAKE PADS AND SPRINGS AND CONDUCTED PERFORMANCE TESTING. THE DEVICE WAS REPAIRED AND CONFIRMED TO BE WITHIN SPECIFICATIONS AND THERE HAVE BEEN NO FURTHER ISSUES REPORTED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED ISSUE. (B)(4).

    Description of Event or Problem · 1

    A COMPANY REP WAS ONSITE AND OBSERVED THAT THE GANTRY CONTINUED TO MOVE DOWN ON ITS OWN AFTER THE SURGEON RELEASED THE JOYSTICK THIS HAPPENED TWO TIMES. ON ONE OCCASION THERE WAS A PT UNDER THE GANTRY AND THE SURGEON WAS ATTEMPTING TO DOCK THE EYE (PREPARATION BEFORE LASER TREATMENT). WHEN THE DOCTOR SAW THE UNEXPECTED GANTRY MOVEMENT, HE MOVED THE JOYSTICK IN THE OPPOSITE DIRECTION AND THE GANTRY STOPPED. THE GANTRY DID NOT CONTACT THE PT AND THERE WAS NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LENSX LASER SYSTEM OPHTHALMIC FEMTOSECOND LASER OOE ALCON LENSX LASERS INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK