ISPAN PERFLUOROPROPANE (C3F8) GAS
Received Apr 21, 2026 · Event occurred Mar 2, 2022
Report 0002518435-2026-00011 · MDR key 24940504
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
- Dry Eye(s)
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 DRY EYE SYNDROME (RIGHT EYE). SURGICAL DATE: (B)(6) 2022. EVENT START: (B)(6) 2022. EVENT END: (B)(6) 2022. MEASURES TAKEN: MEDICATION TREATMENT. AE OUTCOME: RESOLVED. SURGICAL NAME: VITRECTOMY+VITREOUS PUNCTURE INJECTION+COMPLEX RETINAL DETACHMENT REPAIR WITH ANTERIOR MEMBRANE PEELING+RETINAL LASER PHOTOCOAGULATION+RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY (LEFT EYE).