BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1902349 · Received November 11, 2010

    Report

    Report Number
    3003288808-2010-00483
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 12, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    A TECHNICIAN REPORTS THAT THE LASER STOPPED FIRING AT 82% OF THE TREATMENT DUE TO LOSS OF TRACKING. THE REMAINING 18% OF THE TREATMENT WAS NOT PERFORMED AND THE CURRENT STATUS OF THE PT IS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention