BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2160997 · Received June 16, 2011

    Report

    Report Number
    3003288808-2011-00121
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    October 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE ONSITE INVESTIGATION, THE SERVICE TECH COULD NOT FIND ANY PROBLEMS WITH THE LASER. THE LASER WAS WORKING PER SPECIFICATIONS. ROOT CAUSE COULD NOT BE DETERMINED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED ONE PT WITH AN IRREGULAR ABLATION. NO PT HARM 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 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1