BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8 GAS)

    MDR report key: 23575197 · Received November 17, 2025

    Report

    Report Number
    0002518435-2025-00056
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 17, 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

    25K-15 - CLINICAL STUDY CENTER NUMBER: (B)(6), SUBJECT ID: (B)(6). NOTE: SAME PATIENT AND SAME EYE AS 25I-12, (B)(4) (MDR 2518435-2025-00043). SURGERY DATE FOR 25I-12 IS UNKNOWN. DIFFERENT START DATE OF ISSUE REPORTED IN THIS SUBMISSION. A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD INCREASE IN INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING PHACOEMULSIFICATION+IOL IMPLANTATION+POSTERIOR CAPSULOTOMY + VITRECTOMY WITH MEMBRANE PEELING, HEAVY WATER ENDOLASER+PHOTOCOAGULATION, GAS-FLUID EXCHANGE AND C3F8 GAS INJECTION. PHARMOCOTHERAPY GIVEN. PATIENT RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872293 ISPAN PERFLUOROPROPANE (C3F8 GAS) INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC 406501 00380657971039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other