BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2043342 · Received February 25, 2011

    Report

    Report Number
    3003288808-2011-00029
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    January 27, 2011
    Report Date
    January 27, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    TECHNICIAN REPORTS LASER STOPPED DURING TREATMENT, ON ONE PRK CASE. ON FOLLOW UP COMMUNICATION IT WAS REPORTED THAT LASER STOPPED TWICE DURING ONE TREATMENT, AND THE SECOND INTERRUPTION WAS PRECEDED BY AN ENERGY ERROR MESSAGE. SYSTEM WAS REBOOTED AND THE ENERGY CHECK WAS PERFORMED AFTER WHICH THE CASE WAS COMPLETED. SURGEON WAS CONTACTED TO UNDERSTAND POST OPERATIVE STATUS AND HE STATED PATIENT WAS DOING WELL, AS EXPECTED AFTER PRK, AND COMFORTABLE. NO OTHER PATIENT OUTCOME INFORMATION WAS SHARED.

    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