BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2982483 · Received February 26, 2013

    Report

    Report Number
    3003288808-2013-00073
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 1, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 WAS DIAGNOSED WITH GRADE 1 DLK ( DIFFUSE LAMELLAR KERATITIS) IN THE LEFT EYE ON THE FIRST DAY AFTER THE LASIK SURGERY. THE TOPICAL STEROID DROPS WERE INCREASED, AND THE DLK HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80834 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention INTRALASE