ISPAN PERFLUOROPROPANE (C3F8) GAS
Received Apr 21, 2026 · Event occurred Jul 20, 2022
Report 0002518435-2026-00009 · MDR key 24940472
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). SUBJECT ID: (B)(6). A CLINICAL STUDY REPORTED THAT AFTER A SURGERY A PATIENT EXPERIENCE POSTOPERATIVE HIGH INTRAOCULAR PRESSURE (24MMHG IN THE 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 PROCEDURES: VITRECTOMY, VITREOUS PUNCTURE INJECTION, RETINAL LASER PHOTOCOAGULATION, COMPLEX RETINAL DETACHMENT ANTERIOR MEMBRANE PEELING SURGERY, COMPLEX RETINAL DETACHMENT REPAIR URGERY, RETINAL DETACHMENT INTERNAL PRESSURE REPAIR SURGERY (RIGHT EYE).