MIRA Cryosurgical Console CR4000Recalls & reported problems
Mira, Inc. · Ophthalmic Cryo Unit · Class 2
Data updated Oct 18, 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 10850510007467), received between Sep 1, 2021 and Sep 1, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Output Problem” (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.
Most reported problems
Device problems
- Output Problem1
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.
MalfunctionSep 1, 2021Output Problem
DURING LEFT EYE VITRECTOMY, THE CIRCULATING NURSE AND SURGICAL TECH ATTEMPTED TO SET UP THE CRYOSURGERY MACHINE. THE CRYO PROBE INITIALLY WAS APPEARING NOT TO WORK WITH EITHER THE LEFT OR RIGHT TANK. THEN WHEN THE PROBE DID WORK PROPERLY AND INDICATE THAT IT WAS READY FOR USE, THE ATTENDING SURGEON WAS READYING TO PLACE IT TO THE LEFT EYE WHEN IT BEGAN FIRING WITHOUT ANYONE PUSHING THE FOOT PEDAL. THE UNPROMPTED FIRING MADE THE ATTENDING DECIDE TO USE ANOTHER TREATMENT OPTION IN PLACE OF THE CRYO WHICH HE HAD PLANNED ON USING. THIS OCCURRED ONCE MORE AT THE END OF THE CASE WHEN NO ONE WAS NEAR THE CRYO MACHINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12405378 ↗
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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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