Constellation, ULTRAVIT, Engauge 8065752413Recalls & reported problems
Alcon Laboratories, Inc. · 23 GA ULTRAVIT* Vitrectomy Probe Beveled 23 GA/10,000 CPM · Class 2
All models of CONSTELLATION ULTRAVIT ENGAUGE (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Constellation ULTRAVIT vitrectomy probe is a surgical tool used to remove vitreous gel from the eye. Reports mostly describe it failing to cut or having suction problems before or during surgery, sometimes requiring replacement, with no deaths and no injuries reported. There have been 40 adverse event reports and no recalls for this device. Reports rose from 6 in the prior 12 months to 32 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00380657524136), received between Mar 2, 2021 and Sep 30, 2026 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (28 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.
Reports received per month
Most reported problems
Device problems
- Failure to Cut28
- Suction Problem6
- Ambient Noise Problem1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Suction Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information7
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Suction Problem
A physician reported that the vitrectomy probe had no aspiration during vitrectomy surgery. The surgery was completed on the same day after replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945168 ↗MalfunctionAug 13, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232315 ↗MalfunctionMay 20, 2026Failure to Cut
A NURSE REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230722 ↗MalfunctionFeb 18, 2026Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24374620 ↗MalfunctionJan 30, 2026Failure to Cut
A NURSE REPORTED THAT PROBE WOULD NOT CUT BUT THE ASPIRATION CONDITION OF THE PROBE WAS GOOD BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24219208 ↗MalfunctionJan 22, 2026Failure to Cut
A NURSE REPORTED THAT THERE WERE FAILURES OF THE VITRECTOMY PROBES DURING A PARS PLANA VITRECTOMY SURGERY. EVEN BY REDUCING THE CUTTING RATE BY HALF AND REPLACING THE PROBE, THE SURGERY COULD NOT BE COMPLETED DUE TO A POWER FAILURE. THE OPERATION WAS SUBSEQUENTLY COMPLETED WITH ANOTHER ULTRASOUND SURGICAL DEVICE AND THE CORRESPONDING SETS. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24142640 ↗MalfunctionJan 19, 2026Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING AND THE ASPIRATION WAS NORMAL BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24107330 ↗MalfunctionJan 16, 2026Failure to Cut
A NURSE REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24092935 ↗MalfunctionJan 13, 2026Failure to Cut
A NURSE REPORTED THAT THE PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING WITH A NEW PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24050923 ↗MalfunctionJan 5, 2026Suction Problem
A NURSE REPORTED THAT THE BUBBLES WERE SEEN IN ASPIRATION LINE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956004 ↗MalfunctionDec 29, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23904646 ↗MalfunctionDec 26, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895295 ↗MalfunctionDec 26, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE VIT PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS NORMAL. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895040 ↗MalfunctionDec 26, 2025Suction Problem; Suction Problem
A NURSE REPORTED THAT PROBE COULD NOT ASPIRATE BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894664 ↗MalfunctionDec 20, 2025Suction Problem; Suction Problem
A NURSE REPORTED THAT THE PROBE HAD POOR ASPIRATION BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858791 ↗MalfunctionDec 9, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23755888 ↗MalfunctionDec 8, 2025Failure to Cut; Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE DID NOT CUT DURING VITRECTOMY SURGERY. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT AND SURGERY DETAILS.
Patient problems: Insufficient Information
MAUDE report 23740198 ↗MalfunctionDec 8, 2025Failure to Cut; Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE DID NOT CUT DURING VITRECTOMY SURGERY. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT AND SURGERY DETAILS.
Patient problems: Insufficient Information
MAUDE report 23739723 ↗MalfunctionDec 4, 2025Failure to Cut; Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE DID NOT CUT DURING VITRECTOMY SURGERY. THERE WAS NO INFORMATION ABOUT THE PATIENT AND SURGERY DETAILS.
Patient problems: Insufficient Information
MAUDE report 23713477 ↗MalfunctionDec 4, 2025Failure to Cut; Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE DID NOT CUT DURING VITRECTOMY SURGERY. THERE WAS NO INFORMATION ABOUT THE PATIENT AND SURGERY DETAILS.
Patient problems: Insufficient Information
MAUDE report 23713474 ↗MalfunctionDec 2, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT VITRECTOMY PROBE LACKED SUFFICIENT POWER AND WAS UNABLE TO CUT EFFECTIVELY BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23690504 ↗MalfunctionNov 27, 2025Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT THE CUTTER DRIVE FAILURE DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THE OTHER SURGERY DETAILS AND PATIENT IMPACT DETAILS WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 23664358 ↗MalfunctionNov 19, 2025Failure to Cut; Ambient Noise Problem; Failure to Cut; Ambient Noise Problem
A NURSE REPORTED THAT SOUND OF THE PROBE WAS STRANGE AND IT HAD POOR CUTTING PERFORMANCE BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23590644 ↗MalfunctionNov 7, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23496077 ↗MalfunctionNov 7, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE ASPIRATION WAS GOOD. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23494420 ↗
Other Unit, phacofragmentation devices
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- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, ULTRAVIT, Engauge, 25+ 8065752415Alcon Laboratories, Inc. · Unit, phacofragmentation369 reports
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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