BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMTO LDV SYSTEM

    MDR report key: 3131027 · Received May 20, 2013

    Report

    Report Number
    3004858034-2013-00014
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    SIE AG, SURGICAL INSTRUMENT ENGINEERING
    Product Code
    GEX
    PMA / PMN Number
    K053511
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LASIK SURGERY, PT UNDER VACUUM, DEVICE REPORTED ERROR INDICATING OPTICS NOT MOVING, SURGERY ABORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223292 FEMTO LDV SYSTEM FEMTO LDV CRYSTAL GEX SIE AG, SURGICAL INSTRUMENT ENGINEERING CRYSTAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other