BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2192992 · Received July 21, 2011

    Report

    Report Number
    3003288808-2011-00231
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    April 15, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE TERRITORY MANAGER (TM) CONFIRMED THE PROBLEM REGARDING THE TRACKING ISSUES. THE TM REPLACED THE CET BOARD TO ADDRESS THE PROBLEM WITH ACQUIRING THE ACTUAL PATIENT'S EYE, AS THERE WERE NO PROBLEMS IN THE SYSTEM ACQUIRING A TARGET DURING CALIBRATION TESTS. THE ROOT CAUSE WAS A FAULTY CET BOARD (EYETRACKER CIRCUIT BOARD). (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED INTERMITTENT TRACKER OPERATION. DURING FOLLOW UP COMMUNICATION, TECHNICIAN INFORMED THAT THERE WERE NO OUTCOME ISSUES WITH ANY PATIENT THAT HAD TRACKING DIFFICULTY. THE TRACKER NEVER LOST TRACK AND THE PROBLEM WAS THE DIFFICULTY GETTING THE INITIAL TRACK ACQUIRED. THE TIME SPENT ACQUIRING TRACK WITH THE PATIENT WAS MOMENTARY. THERE WAS NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1