ISPAN PERFLUOROPROPANE (C3F8 GAS)
Report
- Report Number
- 0002518435-2025-00051
- Event Type
- Injury
- Date Received
- November 3, 2025
- Date of Event
- August 29, 2025
- Report Date
- December 24, 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
NO SAMPLE WAS RETURNED FOR EVALUATION. ANALYSIS OF THE RETAIN SAMPLE FROM THE SAME MASTER LOT AS LOT 406501 AND 406405 CONFIRMED THE PRODUCT AS C3F8 AND MEETS ALL RELEASE CRITERIA.
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.
(B)(6)_CLINICAL TRIAL STUDY. A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD POSTOPERATIVE HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE FOLLOWING VITRECTOMY+VITREOUS PUNCTURE INJECTION + INTERNAL OPHTHALMOPATHY CONDENSATION + COMPLEX RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY. DRUG THERAPY GIVEN, PATIENT RECOVERED. UPDATE: LOT UPDATED BY ALCON ON DECEMBER 24, 2025, FROM 406501 TO 406405. THESE LOTS ARE FROM THE SAME MASTER LOT OF C3F8.
(B)(6) CLINICAL TRIAL STUDY A HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT EXPERIENCED MILD POSTOPERATIVE HIGH INTRAOCULAR PRESSURE IN THE RIGHT EYE FOLLOWING VITRECTOMY+VITREOUS PUNCTURE INJECTION + INTERNAL OPHTHALMOPATHY CONDENSATION + COMPLEX RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY DRUG THERAPY GIVEN, PATIENT RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1558846 | ISPAN PERFLUOROPROPANE (C3F8 GAS) | INTRAOCULAR GAS | LPO | AIRGAS THERAPEUTICS LLC | 406405 | 00380657971039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |