BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 2181134 · Received July 22, 2011

    Report

    Report Number
    3003288808-2011-00227
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 25, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P0
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTS A PT THAT IS POSSIBLY OVERCORRECTED IN BOTH EYES FOLLOWING REFRACTIVE SURGERY. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE IS BEING REPORTED UNDER MFR REPORT NUMBER 3003288808-2011-00228.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEGRETTO WAVE OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other