BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2982485 · Received February 26, 2013

    Report

    Report Number
    3003288808-2013-00075
    Event Type
    Injury
    Date Received
    February 26, 2013
    Date of Event
    January 24, 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
    NE, 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 UNDERWENT LASIK NOTED BLURRY VISION IN THE RIGHT EYE AND WAS SEEING DOUBLE IN THAT EYE. THE PT WAS DIAGNOSED WITH IRREGULAR ASTIGMATISM. THE PT WAS PRESCRIBED A MYOPIC SOFT CONTACT LENS TO IMPROVE THE POST LASIK VISION, HOWEVER, NOW THE PT IS BEING ASKED TO DISCONTINUE THE CONTACT LENS. AT THIS TIME THERE ARE NO PLANT TO PERFORM A LASER ENHANCEMENT, BUT THE PT WILL BE CHECKED AGAIN IN THE FUTURE. ADD INFO IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81037 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990601 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention INTRALASE