BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISPAN PERFLUOROPROPANE (C3F8 GAS)

    MDR report key: 23910566 · Received December 29, 2025

    Report

    Report Number
    0002518435-2025-00061
    Event Type
    Injury
    Date Received
    December 29, 2025
    Date of Event
    October 18, 2025
    Report Date
    December 29, 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)(6) - CLINICAL STUDY CENTER NUMBER 03, SUBJECT ID (B)(6). A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD HIGH INTRAOCULAR PRESSURE IN THE LEFT EYE FOLLOWING POSTERIOR VITRECTOMY WITH REPLACEMENT INJECTION+VITREOUS DRUG INJECTION+RETINAL LESION LASER COAGULATION+VITREOUS GAS-LIQUID EXCHANGE, RETINAL REPOSITIONING SURGERY DRUG THERAPY GIVEN. PATIENT RECOVERED. LOT NUMBER WAS UPDATED BY CLINICAL COLLEAGUE FROM 406501 TO 406405. THESE LOTS ARE FROM THE SAME MASTER LOT OF C3F8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2111271 ISPAN PERFLUOROPROPANE (C3F8 GAS) INTRAOCULAR GAS LPO AIRGAS THERAPEUTICS LLC 406405 00380657971039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other