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	Glaucoma (1875)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
25k-15 - clinical study center number: (b)(6), subject id: (b)(6).Note: same patient and same eye as 25i-12, (b)(4) (mdr 2518435-2025-00043).Surgery date for 25i-12 is unknown.Different start date of issue reported in this submission.A healthcare professional reported that a patient experienced mild increase in intraocular pressure in the left eye following phacoemulsification+iol implantation+posterior capsulotomy + vitrectomy with membrane peeling, heavy water endolaser+photocoagulation, gas-fluid exchange and c3f8 gas injection.Pharmocotherapy given.Patient recovered.
Additional Manufacturer Narrative
No sample was returned for evaluation.Analysis of the retain sample from the same master lot as lot: 406501 confirmed the product as c3f8 and meets all release criteria.

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8 GAS)
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; plumsteadville PA 18949 0310
• Manufacturer Contact: tim warren ; 6141 easton road; plumsteadville, PA 18949-0310
• MDR Report Key: 23575197
• Report Number: 0002518435-2025-00056
• Device Sequence Number: 9885692
• Product Code: LPO
• UDI-Device Identifier: 00380657971039
• UDI-Public: (01)00380657971039(17)260228(10)406501
• 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): 11/17/2025

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 8065797103
• Device Lot Number: 406501
• 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: 11/12/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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