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	09/23/2025
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 as lot 406501 confirmed the product as c3f8 and meets all release criteria.
Event or Problem Description
(b)(4) clinical trial study, center number 06, subject id (b)(6).A healthcare professional reported that a patient experienced mild elevated intraocular pressure in the left eye following phaco+iol implantation+posterior capsule incision + vitrectomy heavy water photopolymerazation gas- liquid exchange injection (c3f8) medication injection surgery.Drug therapy was given, patient recovered.
Event or Problem Description
25k-11_clinical trial study, center number 06, subject id 06-s6100 a healthcare professional reported that a patient experienced mild elevated intraocular pressure in the left eye following phaco+iol implantation+posterior capsule incision + vitrectomy heavy water photopolymerazation gas- liquid exchange injection (c3f8) medication injection surgery drug therapy was given, patient recovered.New information received on (b)(6) 2026: lot number revised to 2507208.
Additional Manufacturer Narrative
No sample was returned for evaluation.Analysis of the retain sample from the same master lot as lot 2507208 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 -031
• Manufacturer Contact: tim warren ; 6141 easton road; plumsteadville, PA 18949--031
• MDR Report Key: 23544737
• Report Number: 0002518435-2025-00055
• Device Sequence Number: 21164001
• Product Code: LPO
• 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,Followup
• Report Date (Section B): 06/10/2026

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: 2507208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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