CONSTELLATION ULTRAVIT ENGAUGE 8065751571Recalls & reported problems
Alcon Laboratories, Inc. · CONSTELLATION 23 GA 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 UltraVit vitrectomy probe is a surgical instrument used to cut and suction tissue inside the eye during vitrectomy surgery. The 28 reports mostly describe the probe failing to cut or losing suction, which surgeons say slowed or disrupted the operation and in some cases required swapping the instrument mid-surgery. There are no deaths and no injuries reported. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380657515714), received between Mar 29, 2022 and Sep 17, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (23 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 Cut23
- Suction Failure5
- Suction Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- Insufficient Information5
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Failure to Cut
A physician reported that the probe has poor cutting during vitrectomy surgery. The surgery was completed on the same day by replacing the product with new one. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50804579 ↗MalfunctionJul 21, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25888227 ↗MalfunctionJul 3, 2026Failure to Cut
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE HAD NO CUTTING WHICH AFFECTED THE SURGICAL EFFICIENCY DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE INSTRUMENT. THERE WAS PATIENT IMPACT. ADDITIONAL INFORMATION WAS REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 25703465 ↗MalfunctionFeb 3, 2026Failure to Cut
A NURSE REPORTED THAT THE PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243660 ↗MalfunctionJan 12, 2026Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING DURING 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 24039869 ↗MalfunctionJan 6, 2026Suction Problem
A PHYSICIAN REPORTED THAT PROBE COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23971801 ↗MalfunctionNov 26, 2025Suction Problem; Suction Problem
A NURSE REPORTED THAT THE PROBE HAD NO VACUUM DURING VITRECTOMY SURGERY. 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 23656250 ↗MalfunctionNov 17, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23577187 ↗MalfunctionOct 29, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING 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 23412188 ↗MalfunctionSep 2, 2025Suction Problem; Suction Problem
A NURSE REPORTED THAT PROBE WAS OCCLUDED AND NO VACUUM PRESSURE BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22931734 ↗MalfunctionMay 7, 2025Suction Failure; Suction Failure
A NURSE 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 PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21974910 ↗MalfunctionJan 1, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBES HAD NO CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCTS WITH ANOTHER ONE. THERE WAS NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21051251 ↗MalfunctionJan 1, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBES HAD NO CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCTS WITH ANOTHER ONE. THERE WAS NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21051250 ↗MalfunctionAug 28, 2024Failure to Cut; Suction Failure; Failure to Cut; Suction Failure
A NURSE REPORTED THAT THE PROBE HAD NO ASPIRATION AND CUTTING DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20083913 ↗MalfunctionAug 28, 2024Suction Failure; Suction Failure
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20083720 ↗MalfunctionAug 22, 2024Suction Failure; Suction Failure
THE PHYSICIAN REPORTED THAT THERE WAS NO ASPIRATION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PROBE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO PROBE INVOLVED IN THIS REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20024618 ↗MalfunctionJun 21, 2024Failure to Cut; Suction Failure; Failure to Cut; Suction Failure
A CUSTOMER REPORTED THAT THE VITRECTOMY PROBE HAD NO CUTTING AND NO ASPIRATION DURING CALIBRATION. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THE PROCEDURE DETAILS WERE UNKNOWN. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583436 ↗MalfunctionApr 15, 2024Failure to Cut; Failure to Cut
THE NURSE REPORTED THAT PROBE COULD NOT CUT BEFORE THE SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER PROBE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19103573 ↗MalfunctionApr 10, 2024Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT THE POOR CUTTING DURING VITRECTOMY AND CATARACT COMBINATION SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 19079882 ↗MalfunctionApr 9, 2024Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT THE POOR CUTTING DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE PROCEDURE WAS COMPLETED AFTER REPLACEMENT OF NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19071046 ↗MalfunctionJan 3, 2024Failure to Cut; Failure to Cut
A NURSE REPORTED PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. A NEW PRODUCT WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 18433715 ↗MalfunctionNov 3, 2023Failure to Cut; Failure to Cut
A NURSE REPORTED PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. A NEW PRODUCT WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18063616 ↗MalfunctionNov 2, 2023Failure to Cut; Failure to Cut
A NURSE REPORTED THAT THE PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE ASPIRATION CONDITION WAS UNKNOWN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18062450 ↗MalfunctionOct 19, 2023Failure to Cut; Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER DID NOT CUTTING EFFECTIVELY BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17962842 ↗MalfunctionJul 5, 2023Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT DURING THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED BY REPLACING WITH A NEW PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17258173 ↗
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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