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	05/16/2025
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 406405 confirmed the product as c3f8 and meets all release criteria.
Event or Problem Description
25g-11_clinical trial study mild increase in iop (left eye) following phaco+iol +posterior capsule incision+removal of pressure block +vitrectomy, photocoagulation, gas injection (c3f8) surgery.
Additional Manufacturer Narrative
Update to reported lot number.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.Note: original reported lot number 406405 is from the same master as lot 406501.
Event or Problem Description
(b)(4) clinical trial study mild increase in iop (left eye) following phaco+iol +posterior capsule incision+removal of pressure block +vitrectomy, photocoagulation, gas injection (c3f8) surgery.

• 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: 22435735
• Report Number: 0002518435-2025-00036
• Device Sequence Number: 3151447
• 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,Followup
• Report Date (Section B): 09/10/2025

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: 07/03/2025
• Supplement Date Received by Manufacturer: 07/03/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 09/10/2025
• 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