CONSTELLATION ULTRAVIT ENGAUGERecalls & reported problems across all models
Alcon Laboratories, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 637
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 8 models of CONSTELLATION ULTRAVIT ENGAUGE by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 637 adverse event reports in the FDA's MAUDE database, received between Aug 17, 2018 and Sep 30, 2026 — classified as 3 injuries, 634 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (492 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported CONSTELLATION ULTRAVIT ENGAUGE problems
Device problems
- Failure to Cut492
- Suction Problem93
- Suction Failure89
- Air/Gas in Device13
- Break9
- Material Twisted/Bent8
- Decrease in Suction4
- Complete Blockage3
Patient problems
- No Clinical Signs, Symptoms or Conditions577
- Insufficient Information58
- Vitreous Hemorrhage3
- Intraocular Pressure Decreased2
- Intraocular Pressure Increased2
- Joint Contracture1
- No Known Impact Or Consequence To Patient1
CONSTELLATION ULTRAVIT ENGAUGE models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONSTELLATION® ULTRAVIT® ENGAUGE® 8065751438Vitrectomy, instrument cutter237 reports
- CONSTELLATION® ULTRAVIT® ENGAUGE® 8065750949Vitrectomy, instrument cutter203 reports
- CONSTELLATION ULTRAVIT ENGAUGE 8065751570Vitrectomy, instrument cutter128 reports
- Constellation, ULTRAVIT, Engauge 8065752413Unit, phacofragmentation34 reports
- CONSTELLATION ULTRAVIT ENGAUGE 8065751571Vitrectomy, instrument cutter29 reports
- CONSTELLATION® ULTRAVIT® ENGAUGE® 8065751700Instrument, vitreous aspiration and cutting, ac-powered3 reports
- CONSTELLATION® ULTRAVIT® ENGAUGE® 8065750948Vitrectomy, instrument cutter2 reports
- CONSTELLATION® ULTRAVIT® ENGAUGE® 8065750950Vitrectomy, instrument cutter1 report
Recent CONSTELLATION ULTRAVIT ENGAUGE adverse event reports
The 15 most recent reports across all models, 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 ↗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 ↗MalfunctionSep 18, 2026Failure to Cut
A physician reported that vitrectomy probe had poor cutting during 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 50814191 ↗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 ↗MalfunctionAug 24, 2026Suction Problem
A healthcare professional reported that the probe had no suction during vitrectomy surgery. The surgery was completed on the same day after replacing the product with a new one. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50402127 ↗MalfunctionAug 13, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232315 ↗MalfunctionAug 3, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50112912 ↗MalfunctionJul 21, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25888227 ↗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 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 ↗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 ↗MalfunctionJun 30, 2026Failure to Cut
A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING THE PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25663474 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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