BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3810761 · Received March 21, 2014

    Report

    Report Number
    3003288808-2014-00464
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 20, 2014
    Report Date
    February 20, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE VISIT HAS BEEN PERFORMED AND THE INVESTIGATION IS STILL IN PROGRESS, INCLUDING ROOT CAUSE ANALYSIS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT FOLLOWING THE FLAP CREATION AND LIFT, THE PROCEDURE WAS ABORTED DUE TO THE EYE TRACKER ILLUMINATION WAS NOT FUNCTIONING PROPERLY. IN A F/U WITH THE TECHNICIAN, SHE INDICATED THE LASIK PROCEDURE WAS COMPLETED ON (B)(6) 2014 AND THE PT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169676 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR