BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8 GAS)

    MDR report key: 23278422 · Received October 15, 2025

    Report

    Report Number
    0002518435-2025-00046
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    July 21, 2025
    Report Date
    October 9, 2025
    Manufacturer
    AIRGAS THERAPEUTICS LLC
    Product Code
    LPO
    UDI-DI
    00380657971022
    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 (B)(4). SUBJECT ID (B)(6). PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE FOLLOWING LEFT EYE POSTERIOR APPROACH VITRECTOMY+RETINAL LESION CRYOSURGERY+INTRAVITREAL GAS INJECTION, RETINAL REATTACHMENT SURGERY+VITREOUS GAS-LIQUID EXCHANGE+CATARACT PHACOEMULSIFICATION AND ASPIRATION SURGERY. SURGERY DATE (B)(6) 2025 START OF INCIDENT (B)(6) 2025. DRUG THERAPY GIVEN. OUTCOME IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596515 ISPAN PERFLUOROPROPANE (C3F8 GAS) INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC 2505301 00380657971022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other