BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELIGHT FS200 FEMTOSECOND LASER

    MDR report key: 2881551 · Received December 17, 2012

    Report

    Report Number
    3003288808-2012-00518
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 27, 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 INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A TECHNICIAN REPORTED THAT A PT'S FLAP WAS OVAL/INCOMPLETE AND COULD NOT BE LIFTED. THE PT WAS SENT HOME AND WAS TO RETURN TO (B)(6) FOR ASA (ADVANCED SURFACE ABLATION). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 33 YR Required Intervention