MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN SF6 125GM CE SULFUR HEXAFLUORIDE GAS; INTRAOCULAR GAS

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Visual Impairment (2138); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No other information is currently available since attempts to elicit the ispan product (sf6 or pfp) were unsuccessful, this is being reported under sf6, the most likely case.Note from alcon: 13-mar-2026 12:13 (gmt-5:00) added by (b)(6) of alcon: contacted surgeons' office - (b)(6).They will contact the patient to schedule follow up appointment.Patient is spanish speaking.Customer service rep contacted patient and advised him we are unable to provide medical advice that he should contact his surgeon to address the pain.
Event or Problem Description
Airgas therapeutics complaint number (b)(4).Someone reported to alcon customer service stating "causing pulsating pain on the right eye (od) and still not able to see, after process done a month ago." no dates, product information or lot number identification was given.No other information is known.

• Brand Name: ISPAN SF6 125GM CE SULFUR HEXAFLUORIDE 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
• MDR Report Key: 24741454
• Report Number: 0002518435-2026-00001
• Device Sequence Number: 8731038
• Product Code: LPO
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P900067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/31/2026
• 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