BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1921906 · Received December 8, 2010

    Report

    Report Number
    3003288808-2010-00500
    Event Type
    Malfunction
    Date Received
    December 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    SURGEON REPORTS DIFFICULTY TRACKING OVER 50% OF PATIENTS. FIELD ENGINEER NOTED 2 PATIENTS INVOLVED. OPHTHALMIC TECHNICIAN STATED THERE WAS NO DELAY, ALL CASES WERE COMPLETED, NO INDICATION OF HARM OR POST OP CONCERN. ADD'L INFO 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 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1