BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMTO LDV SYSTEM

    MDR report key: 3232053 · Received July 5, 2013

    Report

    Report Number
    3005643720-2013-00005
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    May 30, 2013
    Report Date
    July 5, 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 Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    LASIK FLAP TURNED OUT TO HAVE A BUTTONHOLE AFTER LIFTING; FLAP LAID BACK WITHOUT CONTINUING; FLAP ON SECOND EYE HAD TISSUE BRIDGES, PROCEDURE ABORTED WITHOUT LIFTING; NO INDICATIONS FOR DEVICE MALFUNCTION, PREVIOUS AND SUBSEQUENT OPERATION WORKED FINE; BUTTONHOLE CAN BE CAUSED BY CORNEAL IRREGULARITY OR SCARRING, OR BY PARTICLES TRAPPED IN EYE/APPLANATION INTERFACE; IN THIS CASE DIFFICULTIES WITH BOTH EYES SUGGEST PATIENT-SPECIFIC ISSUE, ALTHOUGH NO IRREGULARITIES WERE APPARENT; PATIENT RESCHEDULED FOR LATER RETREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308319 FEMTO LDV SYSTEM FEMTO LDV CLASSIC GEX SIE AG, SURGICAL INSTRUMENT ENGINEERING CLASSIC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other