BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2191911 · Received July 22, 2011

    Report

    Report Number
    3003288808-2011-00221
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 22, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE TERRITORY MGR (TM) FOUND THE SYSTEM SUCCESSFULLY TRACKED TEST TARGETS. INSPECTION OF THE TRACKER ILLUMINATION REVEALED THAT FOUR OF THE TWELVE INFRA RED (IR) LEDS ON THE RIGHT IR POD WERE NOT OPERATIONAL. REPLACED IR ILLUMINATION ARRAY AND ALIGNED ILLUMINATION. VERIFIED SYSTEM TO SPECIFICATIONS. ROOT CAUSE IS UNK. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTS DIFFICULTY TRACKING 2 PTS DURING SURGERY. NO PT HARM REPORTED. 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