BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8 GAS)

    MDR report key: 23278568 · Received October 15, 2025

    Report

    Report Number
    0002518435-2025-00045
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    July 8, 2025
    Report Date
    October 2, 2025
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657971039
    PMA / PMN Number
    P900066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS RETURNED FOR EVALUATION. ANALYSIS OF THE RETAIN SAMPLE FROM THE SAME MASTER LOT CONFIRMED THE PRODUCT AS C3F8 AND MEETS ALL RELEASE CRITERIA.

    Description of Event or Problem · 0

    (B)(4)_CLINICAL TRIAL STUDY, CENTER NUMBER 6. SUBJECT ID (B)(6). PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE (LEFT EYE) FOLLOWING LEFT EYE VITRECTOMY+MEDICATION INJECTION (TA)+MESH RESTORATION+PHOTOCOAGULATION+HEAVY WATER+GAS-LIQUID EXCHANGE+GAS INJECTION (C3F8) SURGERY. MEDICAL TREATMENT GIVEN, CURRENT CONDITION IS "NO CHANGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2595657 ISPAN PERFLUOROPROPANE (C3F8 GAS) INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC 406501 00380657971039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other