BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE

    MDR report key: 2193735 · Received August 1, 2011

    Report

    Report Number
    3003288808-2011-00242
    Event Type
    Injury
    Date Received
    August 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 2, 2011
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008/P02
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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

    A CLINIC DIRECTOR REPORTED A PT WITH A DIFFERENT RESULT THAN ASSUMED, AFTER SBK LASIK. PT INFO RECEIVED REFLECTS AN OVERCORRECTION. THIS REPORT IS FOR THE RIGHT EYE. LEFT EYE IS REPORTED UNDER MANUFACTURER REPORT # 3003288808-2011-00243.

    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 39 YR Other