BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2982507 · Received February 26, 2013

    Report

    Report Number
    3003288808-2013-00077
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 1, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PT WHO HAD UNDERGONE LASIK WAS DIAGNOSED WITH TRACE DLK (DIFFUSE LAMELLAR KERATITIS) IN BOTH EYES. THE TOPICAL STEROID DROPS WERE PRESCRIBED, THE DLK HAS RESOLVED AND THE PT HAS FINISHED THE DROP THERAPY. THIS REPORT CONCERNS THE PT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80849 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention INTRALASE