BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2800917 · Received October 18, 2012

    Report

    Report Number
    3003288808-2012-00454
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 ADD'L REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AN OPTOMETRIST REPORTED THAT A PT WHO UNDERWENT BILATERAL LASIK, WAS DIAGNOSED WITH ASYMPTOMATIC TRACE DLK (DIFFUSE LAMELLAR KERATITIS) ON THE FIRST DAY POST OP. THE UNCORRECTED VA WAS 20/15. THE STEROID DROPS WERE INCREASED TO TREAT THE DLK AND IT IS NOW RESOLVED. THIS REPORT CONCERNS THE PT'S RIGHT EYE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention INTRALASE