BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3221791 · Received July 9, 2013

    Report

    Report Number
    3003288808-2013-00405
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 13, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED OVER CORRECTION FOLLOWING EPILASIK IN THE PT'S RIGHT EYE. THE SURGEON REPORTED THE SURGEON WAS COMPLETED WITHOUT COMPLICATION. MITOMYCIN C WAS USED AS THE PT HAD FREQUENT SUN EXPOSURE. AFTER SURGERY, THE PT WAS TREATED WITH ANTI-INFLAMMATORY EYE DROPS THREE TIMES A DAY FOR 3 WEEKS. ON DAY TEN POST-OP, THE PT WAS NOTED TO BE OVER CORRECTED, AND REMAINED SO AT TWO MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313591 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other 0.02% MITOMYCIN C