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ISPAN 8065797101Recalls & reported problems

Alcon Laboratories, Inc. · ISPAN C3F8 PERFLUOROPROPANE ISPAN* C3F8 is a fluorinated greenhouse gas covered by the Kyoto Protocol and has a Global Warming Potential (GWP) of 8,600. Residual ISPAN* C3F8 gas should be recovered by appropriately qualified personnel and recycled, reclaimed or destroyed in accordance with local ordinances. · Class 3

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 00380657971015), received between Jul 27, 2021 and Jul 27, 2021 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Intraocular Pressure Increased1
  • Ischemia1
  • Loss of Vision1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A CUSTOMER REPORTED THAT THE WRONG OPHTHALMIC GAS WAS ADMINISTERED THAT CAUSING BLOOD FLOW TO THE EYE TO BE CUT OFF. THE PROCEDURE DETAILS WERE NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REPAIR A RETINAL DETACHMENT IN HER RIGHT EYE (OD). IT WAS NOTED THAT THE INCORRECT GAS WAS GIVEN BY THE STAFF TO THE SURGEON. THE PATIENT EXPERIENCED AN ELEVATION IN HER INTRAOCULAR PRESSURES PROMPTING THE SURGEON TO PERFORM A DRAINAGE PROCEDURE. CURRENTLY THE PATIENT IS EXPERIENCING VISION LOSS IN THE OD.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Intraocular Pressure Increased; Ischemia; Loss of Vision

    MAUDE report 12233211 ↗

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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.