FDA Adverse Event
Injury
Summary report: N
ISPAN PERFLUOROPROPANE (C3F8) GAS
MDR report key: 22214646
·
Received June 16, 2025
Report
- Report Number
- 0002518435-2025-00029
- Event Type
- Injury
- Date Received
- June 16, 2025
- Date of Event
- March 7, 2025
- Report Date
- May 19, 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
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE (LOT 335511) FROM THE SAME MASTER AS LOT 336202 SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA.
Description of Event or Problem · 0
REFERENCE COMPLAINT (B)(4). CASE FROM CLINICAL STUDY THE PHYSICIAN REPORTED THAT FOLLOWING RIGHT EYE "VITRECTOMY", MEMBRANE STRIPPING, PHOTOCOAGULATION, GAS INJECTION, PHACO +IOL IMPLANTATION, THE PATIENT EXPERIENCED MILD ELEVATED INTRAOCULAR PRESSURE AND UNDERWENT MEDICAL TREATMENT. THE OUTCOME WAS RECOVERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1442739 | ISPAN PERFLUOROPROPANE (C3F8) GAS | INTRAOCULAR GAS | LPO | AIRGAS THERAPEUTICS LLC | N/A | 336202 | 00380657971039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |