BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8 GAS)

    MDR report key: 23309117 · Received October 16, 2025

    Report

    Report Number
    0002518435-2025-00048
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    May 8, 2025
    Report Date
    October 15, 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 406405 CONFIRMED THE PRODUCT AS C3F8 AND MEETS ALL RELEASE CRITERIA.

    Description of Event or Problem · 0

    (B)(4)_CLINICAL TRIAL STUDY: A HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING A PATIENT EXPERIENCED MILD OCULAR HYPERTENSION FOLLOWING LEFT EYE PHACOEMULSIFICATION + IOL IMPLANTATION + VITRECTOMY WITH MEMBRANE PEELING PHOTOCOAGULATION AND C3F8 GAS INJECTION SURGERY. CURRENT CONDITION OF PATIENT IS RESOLVED. NOTE: THIS IS THE SAME SURGERY DATE, SAME PATIENT, SAME EYE AS COMPLAINT (B)(4), MDR 2518435-2025-00032, WITH A DIFFERENT ONSET DATE OF ADVERSE EVENT. LOT C3F8 406405 WAS REPORTED FOR THIS COMPLAINT, WHERE THERE WAS A LOT NUMBER CORRECTION TO LOT 406501 FOR COMPLAINT (B)(4). LOTS 406405 AND 406501 ARE FROM THE SAME C3F8 MASTER LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2253702 ISPAN PERFLUOROPROPANE (C3F8 GAS) INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC 406405 00380657971039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other