BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 4173921 · Received October 1, 2014

    Report

    Report Number
    3003288808-2014-01471
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 10, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THE DEVICE HISTORY RECORDS (DHR) FOR THE DEVICE WERE REVIEWED. THE ASSOCIATED DEVICE WAS RELEASED BASED ON THE COMPANY'S ACCEPTANCE CRITERIA. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED A PATIENT WITH DRY EYE SYNDROME AT THE ONE WEEK POST LASIK VISIT IN THE LEFT EYE. PATIENT HAD A GRITTY FEELING IN THE LEFT EYE. THE PATIENT WAS STARTED ON TEAR GEL AT NIGHT WHICH HAS HELPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610732 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INTRALASE