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	Retinal Detachment (2047)
Date of Event	08/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the retain sample lot 120716 showed that the product was pfp and met all release criteria.Nothing was found that would account for the reported event.
Event or Problem Description
Compliant id: (b)(4).Subject id: (b)(6).A clinical study reported that after a surgery a patient experience localized shallow retinal detachment (right eye).Surgical date: (b)(6) 2022.Event start: august 17, 2022.Event end: september 07, 2022.Measures taken: non medication treatment.Ae outcome: resolved.Surgical procedures: vitrectomy+vitreous puncture injection+retinal laser photocoagulation+complex.Etinal detachment anterior membrane peeling surgery+complex retinal detachment repair.Urgery+retinal detachment internal pressure repair surgery (right eye).

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; plumsteadville, pa P.O. BOX ; FR P.O. BOX 3
• 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: 24940480
• Report Number: 0002518435-2026-00010
• Device Sequence Number: 12998436
• Product Code: LPO
• UDI-Device Identifier: 00380657971022
• UDI-Public: (01)00380657971022(17)230731(10)121407
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/16/2026

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 Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 8065797102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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