ISPAN C3F8 Intraocular Gas 20 g CylinderRecalls & reported problems
Escalon Medical Corp. · ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum), and perfluoropropene 10 ppm (maximum). · Class 3
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10860113000109), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE USER FACILITY ENCOUNTERED A VITRECTOMY CASE WHERE A PATIENT RETURNED THE FOLLOWING DAY WITH ONLY APPROXIMATELY 20% OF THE C3F8 GAS REMAINING IN THE EYE. THERE HAVE BEEN NO CHANGES TO THE PROCEDURE FOR DRAWING UP OR ADMINISTERING THE GAS, AND ALL PROTOCOLS WERE FOLLOWED AS USUAL WITH 8 CC C3F8 GAS WITH 52 CC ROOM AIR. GIVEN THESE CONCERNS, THEY HAVE TAKEN THE CURRENT CANISTER OUT OF SERVICE AS A PRECAUTION. THERE WAS NO TRAUMA TO THE PATIENTS EYE; HOWEVER, THE PATIENT RETURNED TO OR FOR REPEAT RETINAL DETACHMENT REPAIR DUE TO POOR GAS FILL WITH RAPID DISSOLUTION OF C3F8 GAS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23594231 ↗
Other Gases Used Within Eye To Place Pressure On Detached Retina devices
- ISPAN 8065797102Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina84 reports
- ISPAN 8065797103Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina38 reports
- ISPAN 8065797105Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina23 reports
- ISPAN 8065797005Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina10 reports
- ISPAN 8065797002Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina9 reports
- ISPAN SF6 Intraocular Gas 20 g CylinderEscalon Medical Corp. · Gases Used Within Eye To Place Pressure On Detached Retina2 reports
- ISPAN 8065797004Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina1 report
- ISPAN 8065797101Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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