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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Glaucoma (1875)
Date of Event	05/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No sample was returned for evaluation.An 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
Reference complaint (b)(4).Case from clinical study (b)(6), subject id (b)(6), patient (b)(6).A health care professional reported that a patient experienced mild elevated intraocular pressure in the left eye after phacoemulsification with iol implantation, pars plana vitrectomy with membrane peeling, photocoagulation, gas-fluid exchange and gas injection (c3f8).The patient was given medical treatment.Outcome is recovered.Pfp lot number 406405 was initially provided, but the follow up details in the report state that the lot was updated to 406501 on (b)(6) 2025.

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton rd.; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton rd.; plumsteadville PA 18949
• Manufacturer Contact: tim warren ; 6141 easton rd.; plumsteadville, PA 18949 ; 2157667407
• MDR Report Key: 22289595
• Report Number: 0002518435-2025-00032
• Device Sequence Number: 15591312
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/30/2025

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 Model Number: N/A
• 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: 05/28/2025
• Initial Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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