BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 2181139 · Received July 22, 2011

    Report

    Report Number
    3003288808-2011-00229
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    May 26, 2011
    Report Date
    June 24, 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
    RS
    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 SURGEON REPORTS A PT THAT HAS CENTRAL ISLAND WITH INDUCED ASTIGMATISM IN BOTH EYES FOLLOWING REFRACTIVE SURGERY. PT RECORDS WERE REC'D AND SHOWED THE PT EXPERIENCED A DECREASE IN BCVA IN THE RIGHT EYE. ADD'L INFO HAS BEEN REQUESTED. THIS REPORT IS FOR THE RIGHT EYE, THE LEFT EYE IS BEING REPORTED UNDER MFR NUMBER 3003288808-2011-00230.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other