BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 1840758 · Received September 17, 2010

    Report

    Report Number
    3003288808-2010-00431
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    August 20, 2010
    Report Date
    August 20, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTS THEY WERE UNABLE TO GET A PUPIL IMAGE ON THE EYETRACKER VIDEO. THE FLAP HAD BEEN MADE ON THE RIGHT EYE AND HAD BEEN LIFTED. THE FLAP WAS PUT BACK DOWN DURING TROUBLESHOOTING, WHICH WAS NOT SUCCESSFUL. THE PATIENT WAS MOVED TO ANOTHER LASER AND THE TREATMENT COMPLETED. ALL REMAINING PATIENTS FOR THE DAY WERE TREATED ON ANOTHER LASER PLATFORM. THE TECHNICIAN STATED THE PATIENT HAS BEEN SEEN POSTOPERATIVELY AND THE SURGEON HAD NO ISSUES OR CONCERNS FOR THE PATIENT'S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR