ISPAN 8065797002Recalls & reported problems
Alcon Laboratories, Inc. · ISPAN SF6 SULFUR HEXAFLUORIDE ISPAN* SF6 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 22,200. Residual ISPAN* SF6 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances. · Class 3
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380657970025), received between Aug 2, 2021 and Sep 29, 2024 — classified as 6 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Short Fill” (4 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Short Fill4
- Adverse Event Without Identified Device or Use Problem2
- Gas Output Problem2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Intraocular Pressure Decreased2
- Retinal Detachment2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2024Gas Output Problem; Gas Output Problem
A CUSTOMER REPORTED THAT DURING CALIBRATION, AN OPHTHALMIC GAS DID NOT COME OUT WHEN CONNECTED TO THE VALVE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20329755 ↗MalfunctionAug 7, 2023Gas Output Problem; Gas Output Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT THE ISSUE OF THE GAS NOT DECANTING PROPERLY HAS BEEN FOR AN EXTENDED PERIOD OF TIME WITH NUMEROUS PATIENTS. ALL SURGERIES WERE ABLE TO BE COMPLETED WITHOUT INCIDENT, EITHER BY WAITING FOR A VERY LONG TIME FOR THE SF6 TO FLOW, OR BY SURGEON CHANGING TO DIFFERENT GAS. ALL PROCEDURES WERE RETINAL VITRECTOMIES. NO SYSTEM USED TO GIVE MESSAGE OR WARNING. NO PATIENT HARM OR SURGICAL COMPLICATION, SIMPLY DELAYED PROCEDURE TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17469060 ↗InjuryNov 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A LITERATURE ARTICLE REVEALED THAT AFTER ONE WEEK OF USING SULFUR HEXAFLUORIDE AND SILICONE OIL THE PATIENT EXPERIENCED WITH ACUTE HYPOTONY.
Patient problems: Intraocular Pressure Decreased
MAUDE report 15860187 ↗InjuryNov 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A STUDY REPORTED THAT AN OPHTHALMIC GAS WAS USED IN THE PROCEDURE AND PATIENTS EXPERIENCED HYPOTONY POST OPERATIVELY. NO FURTHER INFORMATION EXPECTED DUE TO THE UNLIKELIHOOD OF OBTAINING DETAILS.
Patient problems: Intraocular Pressure Decreased
MAUDE report 15826988 ↗InjuryNov 17, 2022Short Fill; Short Fill
A PHYSICIAN REPORTED THAT AFTER VITRECTOMY SURGERY OPHTHALMIC SULPHUR HEXAFLUORIDE (SF6) GAS WAS ALMOST GONE IN THE EYE WITHIN ONE WEEK. PATIENT IMPACT WERE NOT REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED CLARIFYING THAT PATIENT EXPERIENCED RETINAL RE-DETACHMENT AND C3F8 WAS REINJECTED AS TREATMENT. THE ISSUE HAS BEEN RESOLVED.
Patient problems: Retinal Detachment
MAUDE report 15820051 ↗InjuryNov 17, 2022Short Fill; Short Fill
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT PARS PLANA VITRECTOMY (PPV) PROCEDURE FOR RETINAL DETACHMENT. THE MACULA WAS ATTACHED BY USING THE INTRAVITREAL INJECTION OF SULPHUR HEXAFLUORIDE (SF6) GAS AND CRYORETINOPEXY. POST-OPERATIVELY IT WAS OBSERVED THAT THE SF6 GAS DECREASED AND DID NOT COVER THE CAUSATIVE RETINAL BREAK. THE PATIENT REQUIRED PERFLUORO PROPANE (C3F8) INJECTION AND THE GAS WAS EXPANDED WITH ATTACHMENT OF THE MACULA. THE PATIENT CONDITION IMPROVED AND WAS DISCHARGED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15814120 ↗InjuryJul 14, 2022Short Fill; Short Fill
A PHYSICIAN REPORTED THAT A PATIENT UNDERWENT PARS PLANA VITRECTOMY (PPV) PROCEDURE FOR RETINAL DETACHMENT. THE MACULA WAS ATTACHED BY USING THE INTRAVITREAL INJECTION OF SULPHUR HEXAFLUORIDE (SF6) GAS AND CRYORETINOPEXY. POST-OPERATIVELY IT WAS OBSERVED THAT THE SF6 GAS DECREASED AND DID NOT COVER THE CAUSATIVE RETINAL BREAK. THE PATIENT REQUIRED PERFLUORO PROPANE (C3F8) INJECTION AND THE GAS WAS EXPANDED WITH ATTACHMENT OF THE MACULA. THE PATIENT CONDITION IMPROVED AND WAS DISCHARGED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15012098 ↗InjuryJul 14, 2022Short Fill; Short Fill
A PHYSICIAN REPORTED THAT AFTER VITRECTOMY SURGERY OPHTHALMIC SULPHUR HEXAFLUORIDE (SF6) GAS WAS ALMOST GONE IN THE EYE WITHIN ONE WEEK. PATIENT IMPACT WERE NOT REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED CLARIFYING THAT PATIENT EXPERIENCED RETINAL RE-DETACHMENT AND C3F8 WAS REINJECTED AS TREATMENT. THE ISSUE HAS BEEN RESOLVED.
Patient problems: Retinal Detachment
MAUDE report 15011195 ↗MalfunctionAug 2, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A HEALTH PROFESSIONAL REPORTED THAT AN OPHTHALMIC GAS BUBBLE DID NOT EXPAND WHILE INSIDE OF THE PATIENT¿S RIGHT EYE FOR OVER 1-2 WEEKS RATHER, THE BUBBLE JUST DISSIPATED OVER A FEW DAYS WITH NO EXPANSION. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12263768 ↗
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 SF6 Intraocular Gas 20 g CylinderEscalon Medical Corp. · Gases Used Within Eye To Place Pressure On Detached Retina2 reports
- ISPAN 8065797101Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina1 report
- ISPAN C3F8 Intraocular Gas 20 g CylinderEscalon Medical Corp. · Gases Used Within Eye To Place Pressure On Detached Retina1 report
- ISPAN 8065797004Alcon Laboratories, Inc. · Gases Used Within Eye To Place Pressure On Detached Retina1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.