BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3890866 · Received June 11, 2014

    Report

    Report Number
    3003288808-2014-00961
    Event Type
    Injury
    Date Received
    June 11, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    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 ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUIRED. (B)(4).

    Description of Event or Problem · 1

    A CENTER DIRECTOR REPORTED PATIENT WITH DRY EYES AND RECENT DECREASE IN VISION AT EIGHT MONTH LASIK POST-OPERATIVE VISIT. AT VISIT PATIENT "WAS CONCERNED ABOUT RECENT DECREASE". THIS REPORT IS FOR THE LEFT EYE, AND ADDITIONAL REPORT WILL BE FILED FOR THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345971 ALLEGRETTO WAVE EYE-Q OPTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other INTRALASE