BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SULFA HEXA FLUORIDE (SF6)

    MDR report key: 1052685 · Received May 9, 2008

    Report

    Report Number
    1052685
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    November 12, 2007
    Report Date
    May 9, 2008
    Manufacturer
    ALCON LABORATORIES, INC.
    Product Code
    LPO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED THE FOLLOWING PROCEDURE DUE TO A FLASH RELATED TRAUMATIC MACULAR HOLE IN RIGHT EYE, REDUCING VISION TO 20/200: 25G PARS PLANA VITRECTOMY, INDOCYANINE GREEN ASSISTED MEMBRANE PEELING, FLUID AIR EXCHANGE, AND INJECTION OF 30% SF6 GAS (RIGHT EYE). 25G SCLEROTOMY SITES X2 WERE USED AS WELL AS ONE 20G SITE. THE 20G SITE WAS CLOSED W/7 OVICRYL. ACCORDING TO SURGEON, SF6 GAS DISSIPATED FASTER THAN IT SHOULD, WHICH COULD HAVE RESULTED IN THE FAILURE OF THE MACULAR HOLE TO CLOSE. A SECOND SURGERY WAS PERFORMED BY THE SAME PHYSICIAN APPROXIMATELY 5 MONTHS LATER FOR MACULAR HOLE, RIGHT EYE. SURGERY: 23G PARS PLANA VITRECTOMY, FLUID AIR EXCHANGE, INJECTION 20% C3F3 GAS RIGHT EYE. OUTCOME UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SULFA HEXA FLUORIDE (SF6) OPHTHALMIC GAS, SF6 LPO ALCON LABORATORIES, INC. * 623308

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention