BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 1940133 · Received December 22, 2010

    Report

    Report Number
    3003288808-2010-00506
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 24, 2010
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 ADD'L INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    OPHTHALMIC TECHNICIAN REPORTS TRACKER WOULD NOT LOCK ON ONE RIGHT EYE. REPORTER WAS CONTACTED AND SHE STATED, AT TIME OF CASE, PUPIL COULD NOT BE TRACKED FOR APPROXIMATELY ONE MINUTE, AFTER WHICH SURGEON WAS ABLE TO ACQUIRE TRACK AND THE CASE WAS COMPLETED. NO PT OR OUTCOME IMPACT WAS REPORTED. REPORTER DID NOT SHARE PT IDENTIFIERS.

    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