BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C3F8 GAS

    MDR report key: 3162859 · Received June 11, 2013

    Report

    Report Number
    3162859
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    April 16, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ALCON
    Product Code
    LPO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WITH MACULAR RETINAL DETACHMENT WAS TAKEN FOR OUTPATIENT LEFT VITRECTOMY PROCEDURE ON (B)(6) 2013. DURING THE PROCEDURE, THERE WAS THE INJECTION OF C3F8 GAS MIXED WITH AIR. CONCENTRATION UNKNOWN. WHEN THE PT CAME FOR HIS FOLLOW-UP APPOINTMENT THE FOLLOWING DAY, HE HAD PRESSURE IN THE 50-60'S, NORMAL IS IN THE 20'S. THE OPHTHALMOLOGIST EXTRACTED .6 TO .7 CC OUT OF THE EYE. THE FOLLOWING DAY, THE PRESSURE WAS BACK UP IN THE 60'S. THE OPHTHALMOLOGIST HAS TO PERFORM THE EXTRACTION AGAIN. THE PRESSURE WENT BACK UP AGAIN TO 60-70'S. AT THIS TIME, THE PT HAS NO SIGHT IN HIS LEFT EYE. THE SURGEON IS CONCERNED THAT THE GAS IN THE CYLINDER MAY HAVE CAUSED THIS CONTINUING EYE PRESSURE PROBLEM. AT THIS TIME, PT'S LEFT EYE VISION IS 0 AND RIGHT EYE IS 80. (B)(4). .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262957 C3F8 GAS LPO ALCON 117603

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR