MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN PERFLUOROPROPANE (C3F8 GAS); INTRAOCULAR GAS

Catalog Number	8065797103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Conjunctival Hemorrhage (4808)
Date of Event	07/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for evaluation.Analysis of the retain sample from the same master lot confirmed the product as c3f8 and meets all release criteria.
Event or Problem Description
(b)(4)_clinical trial study, center number (b)(4).Subject id (b)(6).Patient experienced mild subconjunctival hemorrhage in the left eye following pars plana vitrectomy+retinal lesion laser photocoagulation + intravitreal gas injection, retinal repositioning surgery+vitreous gas-liquid exchange.Surgery date (b)(6) 2025 start of incident (b)(6) 2025.Drug therapy given.Outcome is recovered.

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8 GAS)
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; plumsteadville PA 18949 0310
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; plumsteadville PA 18949 0310
• Manufacturer Contact: tim warren ; 6141 easton road; plumsteadville, PA 18949-0310 ; 2157667407
• MDR Report Key: 23278474
• Report Number: 0002518435-2025-00047
• Device Sequence Number: 5470240
• Product Code: LPO
• UDI-Device Identifier: 00380657971022
• UDI-Public: (01)00380657971022(17)270131(10)2505301
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P900066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 8065797103
• Device Lot Number: 2505301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown