CONSTELLATION ULTRAVIT ENGAUGE 8065751570Recalls & reported problems
Alcon Laboratories, Inc. · CONSTELLATION 25+ ULTRAVIT VITRECTOMY PROBE, 7500 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 vitrectomy probe is a surgical cutting tool used during eye surgery to remove the vitreous gel inside the eye. All 127 reports are malfunctions, with no injuries or deaths; most describe the probe failing to cut or losing suction during surgery, with surgeons replacing it to finish the procedure. Reports rose to 53 in the last 12 months from 30 in the 12 months before. No recalls name this device.
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
- 128
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 128 adverse event reports that list this exact device (DI 00380657515707), received between Jun 17, 2021 and Sep 25, 2026 — classified as 128 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (91 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 Cut91
- Suction Problem26
- Suction Failure8
- Break3
- Material Twisted/Bent2
- Air/Gas in Device1
- Disconnection1
- Failure to Calibrate1
Patient problems
- No Clinical Signs, Symptoms or Conditions115
- Insufficient Information13
Recent adverse event reports
The 25 most recent of 128 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Failure to Cut
A physician reported that the vitrectomy probe was unable to cut normally during 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 50894960 ↗MalfunctionSep 24, 2026Failure to Cut
A physician reported that probe had poor cutting during vitrectomy surgery. The surgery was completed on same day by replacing it with new product. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883316 ↗MalfunctionSep 24, 2026Failure to Cut
A nurse reported that the probe stopped cutting 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 50882399 ↗MalfunctionSep 21, 2026Failure to Cut
A non-healthcare professional reported via health authority that abnormal poor cutting performance during vitrectomy surgery. The surgery was completed on the same day by replacing the product with new one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835050 ↗MalfunctionAug 3, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112912 ↗MalfunctionJul 20, 2026Failure to Cut
A PHYSICIAN REPORTED THAT VITRECTOMY PROBE WAS UNABLE TO PERFORM NORMAL CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING IT WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25869289 ↗MalfunctionJul 2, 2026Failure to Cut
A PHYSICIAN REPORTED THAT PROBE WAS UNABLE TO PERFORM NORMAL CUTTING DURING THE 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 25688536 ↗MalfunctionMar 25, 2026Suction Failure
A HEALTHCARE PROFESSIONAL REPORTED THAT COULD NOT ASPIRATE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY, BUT IT WAS UNKNOWN HOW IT WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687294 ↗MalfunctionMar 5, 2026Failure to Cut
A PHYSICIAN REPORTED THAT VITRECTOMY PROBE WAS UNABLE TO CUT THE VITREOUS BODY PROPERLY DURING VITRECTOMY SURGERY. AFTER REPEATED EXAMINATIONS, THE VITRECTOMY PROBE COULD NOT CUT BACK AND FORTH NORMALLY, RESULTING IN THE INABILITY TO PERFORM THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518753 ↗MalfunctionFeb 27, 2026Failure to Cut
A NURSE REPORTED THAT THE PROBE HAD POOR CUTTING DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469343 ↗MalfunctionFeb 19, 2026Failure to Cut
A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24386339 ↗MalfunctionFeb 9, 2026Failure to Cut
A NURSE REPORTED THAT PROBE COULD NOT CUT AND EVEN CUTTING SPEED WAS REDUCING, IT STILL COULD NOT CUT DURING 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 24289212 ↗MalfunctionJan 19, 2026Failure to Cut
A PHYSICIAN REPORTED THAT THE PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE ASPIRATION CONDITION WAS NORMAL. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24108128 ↗MalfunctionJan 9, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE OUTER PACKAGING WAS INTACT DURING USE AND VITRECTOMY PROBE PASSED THE TEST, BUT FOUND THAT THE PROBE COULD NOT ASPIRATE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE WITHOUT AFFECTING THE SURGICAL PROGRESS. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24017453 ↗MalfunctionJan 7, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE PROBE HAD NO ASPIRATION DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23995411 ↗MalfunctionJan 7, 2026Suction Problem
A PHYSICIAN REPORTED THAT PROBE COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING IT WITH NEW PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23992661 ↗MalfunctionJan 7, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE GLASS CUTTING HEAD WAS NOT SUCTIONING DURING THE VITRECTOMY SURGERY AND PROMPTLY REPLACED IT WITH A NEW PRODUCT WITHOUT AFFECTING THE SURGICAL PROGRESS. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23990025 ↗MalfunctionJan 6, 2026Suction Failure
A PHYSICIAN REPORTED ASPIRATION FAILURE OF THE PROBE OCCURRED DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF CUTTING WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT ANY IMPACT TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 23975322 ↗MalfunctionDec 29, 2025Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT THE PROBE WAS NOT SUCTIONING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23904645 ↗MalfunctionDec 28, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION DURING 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 23903981 ↗MalfunctionDec 26, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT AFTER PASSING THE TEST PROBE COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH NEW PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23894837 ↗MalfunctionDec 24, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT ASPIRATE DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23886860 ↗MalfunctionDec 24, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT PROBE COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING WITH ANOTHER PRODUCT. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23886329 ↗MalfunctionDec 23, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23878769 ↗MalfunctionDec 23, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE DID NOT ASPIRATE DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23877998 ↗
Other Vitrectomy, instrument cutter devices
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752450Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls1,160 reports
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752437Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls1,023 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000095Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls616 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753106Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls546 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000096Alcon Laboratories, Inc. · Vitrectomy, instrument cutter1 recall554 reports
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752451Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls258 reports
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752438Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls203 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753109Alcon Laboratories, Inc. · Vitrectomy, instrument cutter1 recall223 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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