BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1761096 · Received July 15, 2010

    Report

    Report Number
    3003288808-2010-00378
    Event Type
    Malfunction
    Date Received
    July 15, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 15, 2010
    Manufacturer
    WAVELIGHT AG (PRESSATH)
    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

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "INCOMPLETE TREATMENT" (NO CODE AVAILABLE). PRODUCT PROBLEM(S): "ENERGY TOO LOW" (OUTPUT ENERGY INCORRECT). A TECH REPORTS DURING SURGERY, THE PT HAD EXCESSIVE MOVEMENT AND LOST TRACK AT 64% OF TREATMENT ON THE LEFT EYE. THE TECH PRESSED THE START KEY AGAIN TO PROCEED. THE LASER STOPPED AGAIN AT 89% WITH A SYSTEM MESSAGE AND THEY COULD NOT PROCEED ANY FURTHER. THE DOCTOR CHOSE NOT TO COMPLETE THE SURGERY. AT ONE DAY POST-OP, THE PATIENT'S UCVA IN THE LEFT EYE WAS 20/20. THE SURGEON STATED HE FEELS THAT THE PATIENT WILL NOT HAVE ANY PROBLEMS WITH THE OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR