ISPAN PERFLUOROPROPANE (C3F8) GAS
Received Apr 14, 2026 · Event occurred Jul 26, 2022
Report 0002518435-2026-00005 · MDR key 24873428
Device
Generic name
Intraocular Gas
Manufacturer
Airgas Therapeutics LlcModel number
N/ACatalog number
8065797102
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- Intraocular Pressure Increased
Narrative
Additional Manufacturer Narrative
AN ANALYSIS OF THE RETAIN SAMPLE LOT 120716 SHOWED THAT THE PRODUCT WAS PFP AND MET ALL RELEASE CRITERIA. NOTHING WAS FOUND THAT WOULD ACCOUNT FOR THE REPORTED EVENT.
Description of Event or Problem
COMPLIANT ID: (B)(4). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE ELEVATED INTRAOCULAR PRESSURE (RIGHT EYE: 40 MMHG). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL PROCEDURES: PARS PLANA VITRECTOMY + INTRAVITREAL INJECTION + MEMBRANE PEELING FOR COMPLEX RETINAL. DETACHMENT REPAIR + RETINAL LASER PHOTOCOAGULATION + INTRAOCULAR GAS TAMPONADE (RIGHT EYE).