BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3142987 · Received May 30, 2013

    Report

    Report Number
    3003288808-2013-00313
    Event Type
    Injury
    Date Received
    May 30, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. PT CODE: 1944, 3191 - NOT LABELED. DEVICE CODE: 2993 - NOT LABELED. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORT THAT A PT WHO UNDERWENT LASIK WAS DIAGNOSED WITH ASYMPTOMATIC TRACE DIFFUSE LAMELLAR KERATITIS IN THE LEFT EYE, AT THE ONE DAY POST-OP VISIT. THE TOPICAL STEROID DROPS WERE INCREASED. UPON F/U, REPORTER MENTIONED THAT THE DLK HAS RESOLVED FIVE DAYS AFTER SURGERY, AND THE UCVA REMAINED 20/20. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238265 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention INTRALASE