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ISPAN SF6 Intraocular Gas 20 g CylinderRecalls & reported problems

Escalon Medical Corp. · ISPAN Sulfur Hexafluoride (SF6) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is a colorless, odorless, non-toxic, non-flammable gas. The boiling point is -63.9°C (-83°F) and the vapor pressure at 20°C is 320 psig (pounds per square inch gauge). ISPAN SF6 purity: sulfur hexafluoride 99.99% (minimum), air 100 ppm (maximum), carbon tetrafluoride 100 ppm (maximum), and hydrogen fluoride 0.3 ppm (maximum). · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10860113000116), received between Apr 12, 2019 and Apr 12, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information2

Patient problems

  • Retinal Detachment2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    EVENT: CASE 2 OF 2. CUSTOMER REPORTED TO DISTRIBUTOR THAT THEY HAD BEEN USING A GAS CYLINDER OF SULFUR HEXAFLUORIDE SINCE (B)(6) 2017 WITH NO ISSUES BUT TWO RECENT CASES INVOLVING RETINA RE-ATTACHMENT HAD RE-DETACHED. NO FURTHER INFORMATION WAS PROVIDED NOT WERE ADDITIONAL REPORTS PROVIDED THAT PATIENTS EVENTUALLY HAD SUCCESSFUL REATTACHMENT OR NOT. NO INDIVIDUAL PATIENT INFORMATION IS KNOWN SUCH AS AGE, SEX, ETC. ON 2/27/2018, THE DISTRIBUTOR REPORTED THE CASE. THE ACTUAL DATE OF THE PATIENT EVENTS IS UNKNOWN OTHER THAN THAT THEY OCCURRED ON THE SAME DAY. THE PRODUCT WAS RETURNED TO MANUFACTURER. MANUFACTURER CONDUCTED A REVIEW OF THE BATCH PRODUCT RECORD AND DISCOVERED NO ISSUES. MANUFACTURER ALSO RE-ANALYZED THE CYLINDER OF GAS AND THE PRODUCT MET THE ORIGINAL SPECIFICATION.

    Patient problems: Retinal Detachment

    MAUDE report 8511389 ↗
  • InjuryApr 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    EVENT: CASE 1 OF 2. CUSTOMER REPORTED TO DISTRIBUTOR THAT THEY HAD BEEN USING A GAS CYLINDER OF SULFUR HEXAFLUORIDE SINCE (B)(6) 2017 WITH NO ISSUES BUT TWO RECENT CASES INVOLVING RETINA RE-ATTACHMENT HAD RE-DETACHED. NO FURTHER INFORMATION WAS PROVIDED NOR WERE ADDITIONAL REPORTS PROVIDED THAT PATIENTS EVENTUALLY HAD SUCCESSFUL REATTACHMENT OR NOT. NO INDIVIDUAL PATIENT INFORMATION IS KNOWN SUCH AS AGE, SEX, ETC.. ON 2/27/2018, THE DISTRIBUTOR REPORTED THE CASE. THE ACTUAL DATE OF THE PATIENT EVENTS IS UNKNOWN OTHER THAN THAT THEY OCCURRED ON THE SAME DAY. THE PRODUCT WAS RETURNED TO MANUFACTURER. MANUFACTURER CONDUCTED A REVIEW OF THE BATCH PRODUCT RECORD AND DISCOVERED NO ISSUES. MANUFACTURER ALSO RE-ANALYZED THE CYLINDER OF GAS AND THE PRODUCT MET THE ORIGINAL SPECIFICATION.

    Patient problems: Retinal Detachment

    MAUDE report 8511384 ↗

Other Gases Used Within Eye To Place Pressure On Detached Retina devices

All Gases Used Within Eye To Place Pressure On Detached Retina devices →

Sources and updates

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