BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASTER

    MDR report key: 3960173 · Received July 17, 2014

    Report

    Report Number
    3003288808-2014-01135
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED A PATIENT WITH VERTICAL GAS BREAKTHROUGH OF THE RIGHT EYE. ADDITIONAL INFORMATION FROM REPORTER INDICATED THAT THE PROCEDURE WAS ABORTED AND THE PATIENT WAS RESCHEDULED FOR FLAP LIFT AND TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417577 WAVELIGHT FS200 FEMTOSECOND LASTER OPHTHALMIC FEMTOSECOND LASER GEX WAVELIGHT GMBH FS200 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other