BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8 GAS)

    MDR report key: 23522431 · Received November 11, 2025

    Report

    Report Number
    0002518435-2025-00052
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    September 19, 2025
    Report Date
    November 11, 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 AS LOT 406501 CONFIRMED THE PRODUCT AS C3F8 AND MEETS ALL RELEASE CRITERIA.

    Description of Event or Problem · 0

    (B)(4) CLINICAL TRIAL STUDY, (B)(6), SUBJECT (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MODERATE POSTOPERATIVE INCREASED INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING VITRECTOMY WITH MEMBRANE PEELING, ENDOLASER PHOTOCOAGULATION, RETINAL REPAIR, GAS FLUID EXCHANGE, USE OF HEAVY WATER, C3F8 GAS FILL, AND POSTERIOR CAPSULOTOMY. PHARMOCOTHERAPY WAS GIVEN, PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2614949 ISPAN PERFLUOROPROPANE (C3F8 GAS) INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC 406501 00380657971039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other