BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2150654 · Received June 22, 2011

    Report

    Report Number
    3003288808-2011-00191
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 23, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). THIS REPORT WAS MAILED TO FDA ON: (B)(4) 2011. (B)(4).

    Description of Event or Problem · 1

    A LASER TECHNICIAN REPORTED THE LASER SYSTEM WOULD NOT READ THE CARD AFTER ONE TREATMENT WAS USED. DURING FOLLOW-UP, THE TECHNICIAN STATED THEY TEST ALL THE CARDS UPON RECEIPT AND THIS ONE WAS TESTED AND PASSED. HOWEVER, THE CARD SHOWED NO TREATMENT LEFT ON THE FIRST USE, BUT RESUMED AFTER IT WAS REINSERTED.

    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