BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIEMER LDV FEMTOSECOND LASER

    MDR report key: 2037675 · Received March 23, 2011

    Report

    Report Number
    MW5020012
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    December 9, 2010
    Report Date
    February 8, 2011
    Manufacturer
    ZIEMER USA INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS PREPPED FOR LASIK SURGERY IN THE USUAL FASHION. THE ZIEMER FEMTOSECOND LASER WAS USED IN THE NORMAL FASHION. SUCTION WAS OBTAINED ON THE RIGHT EYE AND VERIFIED BY THE SURGEON. THE LASER WAS "ENGAGED" AND ALLOWED TO TRACK IN THE TYPICAL FASHION ACROSS THE CORNEAL BED. WHEN IT WAS REMOVED FROM THE EYE, THE CORNEA APPEARED TO BE NORMAL UNDER THE MICROSCOPE WITH THE BUBBLES IN THE INTERFACE. THE PT CHAIR WAS THEN TURNED TO PLACE THE PT'S HEAD UNDER THE EXCIMER LASER MICROSCOPE. AT THIS TIME, THE SURGEON DETERMINED THAT THE BUBBLES WHICH WERE CREATED BY THE FS LASER WERE TOO ANTERIOR AND THEREFORE, THERE WOULD NOT BE ENOUGH TISSUE TO CREATE A CORNEAL FLAP. AT THIS TIME ANTIBIOTICS AND STEROID DROPS WERE INSTILLED INTO THE RIGHT EYE. THE PT WAS INFORMED THAT THE FLAP WAS NOT PERFECT AND THAT THE PROCEDURE WOULD NEED TO BE CANCELLED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIEMER LDV FEMTOSECOND LASER ZIEMER, LDV GEX ZIEMER USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention