BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3030289 · Received March 28, 2013

    Report

    Report Number
    3003288808-2013-00134
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 4, 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 A ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECH REPORTED THAT A PT WHO HAD UNDERGONE LASIK WAS DIAGNOSED WITH TRACE DLK (DIFFUSE LAMELLAR KERATITIS) IN THE LEFT EYE AT THE ONE DAY POST-OP EXAM. TOPICAL STEROID DROPS WERE INCREASED IN FREQUENCY, THE DLK HAS RESOLVED, AND THE PT HAS FINISHED THE DROP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130009 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