ISPAN 8065797004Recalls & reported problems
Alcon Laboratories, Inc. · TANK SF6 CONSTELLATION LD5 · Class 3
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380657970049), received between Mar 30, 2023 and Mar 30, 2023 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
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.
MalfunctionMar 30, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A PHYSICIAN REPORTED THAT OPHTHALMIC OPERATING CONSOLE WAS NOT DISPENSING SULPHUR HEXAFLUORIDE GAS AND GAS BUBBLE IN PATIENT EYE WAS REDUCED TO UNUSUAL SIZE IT WAS NOTICED ON POST OPERATIVE DAY EIGHT. THERE WERE NO DETAILS OF THE PROCEDURE. THERE WAS NO REPORT OF THE PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643265 ↗
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 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
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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