ISPAN PERFLUOROPROPANE (C3F8) GAS
Received Apr 14, 2026 · Event occurred Apr 10, 2022
Report 0002518435-2026-00007 · MDR key 24873486
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)(6). A CLINICAL STUDY ((B)(4)) REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE ELEVATED INTRAOCULAR PRESSURE (LEFT EYE, T+3). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: PHARMACOLOGICAL TREATMENT. AE OUTCOME: RECOVERED. PHACOEMULSIFICATION CATARACT EXTRACTION + VITRECTOMY + INTRAVITREAL INJECTION + EPIRETINAL MEMBRANE. PEELING PRIOR TO COMPLEX RETINAL DETACHMENT REPAIR + MACULAR HOLE CLOSURE + RETINAL LASER. PHOTOCOAGULATION + INTERNAL TAMPONADE FOR COMPLEX RETINAL DETACHMENT (LEFT EYE).