BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 2479790 · Received February 27, 2012

    Report

    Report Number
    3008772169-2012-00006
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE ENGINEER WAS DISPATCHED TO INVESTIGATE THE LASER SYSTEM. THE ENGINEER WAS ABLE TO REPRODUCE THE ISSUE AND REPORTED THAT THE GANTRY MOVED IN THE Z DIRECTION (DOWN) WITHOUT INFLUENCE OF THE JOYSTICK. TO STOP THE DIRECTION OF THE MOTION, THE JOYSTICK HAD TO BE TOUCHED. THE ENGINEER FOUND CONTAMINATION ON SURFACES OF BRAKE ASSEMBLY WHICH REDUCED STOPPING FORCE AND ALLOWED GRAVITY TO MOVE GANTRY DOWN WARDS. THE DEVICE WAS REPAIRED AND CLEANED 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 REPRESENTATIVE WAS ONSITE AND OBSERVED THAT THE GANTRY MOVED DOWN WITHOUT TOUCHING THE JOYSTICK (NO PATIENT INVOLVEMENT). THE FOLLOWING DAY THE COMPANY REPRESENTATIVE WAS OBSERVING SURGERIES AND AFTER A LASER PROCEDURE THE LASER GANTRY MOVED DOWN AND THE SYSTEM GENERATED A "Z SERVO MOTOR" MESSAGE. THE GANTRY DID NOT CONTACT THE PATIENT AND THERE WAS NO PATIENT INJURY. THE PATIENT HAD A CAPSULOTOMY TAG (AREA OF INEFFECTIVE PHOTODISRUPTION) AT THE 3 O'CLOCK POSITION, BUT THIS DID NOT RESULT IN 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 57 YR