BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2800815 · Received October 17, 2012

    Report

    Report Number
    3003288808-2012-00452
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    August 3, 2012
    Report Date
    September 17, 2012
    Manufacturer
    WAVELIGHT GMBH
    Product Code
    GEX
    PMA / PMN Number
    K101006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A PT EXPERIENCED A BUTTON HOLE DURING THE PROCEDURE ON THE RIGHT EYE. THE BUTTON HOLE IS LOCATED AT THE EDGE OF THE POCKET, NEXT TO THE CANAL. ADDITIONAL INFO HAS BEEN REQUESTED ON MULTIPLE OCCASIONS, BUT NOT HAS BEEN PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other