BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLEGRETTO WAVE EYE-Q

    MDR report key: 3181517 · Received June 17, 2013

    Report

    Report Number
    3003288808-2013-00347
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    April 26, 2013
    Report Date
    May 20, 2013
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    LZS
    PMA / PMN Number
    P030008
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    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 SURGEON REPORTED LARGER ABLATION, MORE TISSUE REMOVED, POST BILATERAL LASEK/PRK TREATMENT. THIS REPORT CONCERNS THE PT'S LEFT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273007 ALLEGRETTO WAVE EYE-Q OPHTHALMIC EXCIMER LASER SYSTEM LZS WAVELIGHT GMBH 8065990631 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention MITOMYCIN C, (B)(6), FOR 30 SECONDS| ETHANOL (B)(6), FOR 20 SECONDS