BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1950169 · Received December 9, 2010

    Report

    Report Number
    3003288808-2010-00499
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, 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

    OPHTHALMIC TECHNICIAN REPORTS THAT ONE CASE WAS INTERRUPTED AT 94% TREATMENT COMPLETION, AND SYSTEM DISPLAYED SECONDARY ENERGY LOW MESSAGE, AND REPORTED ANOTHER MESSAGE WAS RECEIVED TELLING THEM TO WAIT 20 SECONDS BEFORE THEY COULD CONTINUE. TECHNICIAN STATED THAT THE SYSTEM DID ALLOW THEM TO CONTINUE TO COMPLETE REMAINING PORTION OF TREATMENT. INFO IS BEING SOUGHT TO UNDERSTAND PT OUTCOME.

    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