BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2161077 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00129
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    February 3, 2010
    Report Date
    February 3, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/PO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE SVC REP EXAMINED THE SYS AND THE LOG FILES AND FOUND THERE WAS NO MALFUNCTION OF THE DEVICE. A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED, HOWEVER, THE MOST LIKELY REASON WOULD BE PT FACTORS LIKE WOUND HEALING. (B)(4).

    Description of Event or Problem · 1

    A PHYSICIAN REPORTS IRREGULAR ABLATIONS IN THE CASE OF HIGHER MYOPIC ABLATIONS IN THE 7MM ZONE. FOUR PTS HAD VERY SIMILAR RESULTS. NO PT HARM WAS REPORTED AND NO FURTHER INFO WAS PROVIDED.

    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