ISPAN PERFLUOROPROPANE (C3F8) GAS
Received Apr 21, 2026 · Event occurred Aug 17, 2022
Report 0002518435-2026-00010 · MDR key 24940480
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
- Retinal Detachment
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). SUBJECT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE LOCALIZED SHALLOW RETINAL DETACHMENT (RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: AUGUST 17, 2022. EVENT END: SEPTEMBER 07, 2022. MEASURES TAKEN: NON MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL PROCEDURES: VITRECTOMY+VITREOUS PUNCTURE INJECTION+RETINAL LASER PHOTOCOAGULATION+COMPLEX. ETINAL DETACHMENT ANTERIOR MEMBRANE PEELING SURGERY+COMPLEX RETINAL DETACHMENT REPAIR. URGERY+RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY (RIGHT EYE).