BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3830120 · Received May 1, 2014

    Report

    Report Number
    3003288808-2014-00757
    Event Type
    Injury
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFO BECOMES AVAILABLE. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A FOREIGN BODY UNDER THE FLAP ONE DAY POST LASIK IN THE LEFT EYE. PT WAS TAKEN IN TO HAVE A FLAP LIFT AND RINSE. THE STEROID AND ANTIBIOTIC DROPS WERE INCREASED. ADDITIONAL INFO HAS BEEN REQUESTED BUT NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261667 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention INTRALASE