Constellation, Ultravit, 25+, TotalPlus, EngaugeRecalls & reported problems across all models
Alcon Laboratories, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Constellation, Ultravit, 25+, TotalPlus, Engauge model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 349
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 3 models of Constellation, Ultravit, 25+, TotalPlus, Engauge by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 349 adverse event reports in the FDA's MAUDE database, received between Mar 4, 2021 and Aug 12, 2026 — classified as 3 injuries, 346 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (166 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Constellation, Ultravit, 25+, TotalPlus, Engauge recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 28, 2025Open, Classified
Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage in the lidding is visibly noticeable, due to risk of sterility being compromised.
Z-2109-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Constellation, Ultravit, 25+, TotalPlus, Engauge problems
Device problems
- Failure to Cut166
- Fluid/Blood Leak39
- Suction Failure35
- Leak/Splash21
- No Flow21
- Break20
- Suction Problem16
- Air/Gas in Device13
Patient problems
- No Clinical Signs, Symptoms or Conditions303
- Insufficient Information45
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Intraocular Pressure Increased1
- Retinal Tear1
- Vitreous Hemorrhage1
Constellation, Ultravit, 25+, TotalPlus, Engauge models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Constellation, Ultravit, 25+, TotalPlus, Engauge 8065751462Unit, phacofragmentation220 reports
- Constellation, Ultravit, 25+, TotalPlus, Engauge 8065751468Unit, phacofragmentation129 reports
- Constellation, Ultravit, 25+, TotalPlus, Engauge 8065751715Unit, phacofragmentation1 recall0 reports
Recent Constellation, Ultravit, 25+, TotalPlus, Engauge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 12, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218383 ↗MalfunctionMar 6, 2026Failure to Cut
A PHYSICIAN REPORTED THAT VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528248 ↗MalfunctionMar 2, 2026Failure to Cut
A PHYSICIAN REPORTED THAT VITRECTOMY PROBE WAS UNABLE TO CUT PROPERLY BEFORE VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24478918 ↗MalfunctionJan 20, 2026Failure to Cut
A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BUT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24112773 ↗MalfunctionJan 14, 2026Failure to Cut
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED BY REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO REPORTED INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24065485 ↗MalfunctionJan 4, 2026Failure to Cut
A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR CUTTING DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BUT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23954164 ↗MalfunctionDec 26, 2025Failure to Cut; Failure to Cut
A NURSE REPORTED THAT PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894838 ↗MalfunctionDec 18, 2025Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT PROBE HAD NO CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23837681 ↗MalfunctionDec 8, 2025Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE ASPIRATION CONDITION WAS NORMAL. 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 23741202 ↗MalfunctionDec 3, 2025Failure to Cut; Failure 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. THE CONDITION OF ASPIRATION WAS UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23702395 ↗MalfunctionNov 27, 2025Improper Flow or Infusion; Improper Flow or Infusion
A PHYSICIAN REPORTED THAT FLUID-AIR-EXCHANGE WAS UNABLE TO PERFORM BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING WITH NEW PRODUCT. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: Insufficient Information
MAUDE report 23665365 ↗MalfunctionNov 25, 2025Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT VITRECTOMY PROBE COULD NOT CUT BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE CONDITION OF ASPIRATION WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT ANY IMPACT TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 23642798 ↗MalfunctionNov 12, 2025Failure to Cut; Failure to Cut
A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PROBE COULD NOT CUT 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 23530349 ↗MalfunctionNov 12, 2025Suction Problem; Suction Problem
A NURSE REPORTED THAT PROBE HAD NO ASPIRATION DURING THE VITRECTOMY SURGERY. THE SURGERY PROCEEDED NORMALLY AFTER REPLACING WITH A NEW ONE. THERE WAS NO REPORT OF PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23529789 ↗MalfunctionOct 24, 2025Failure to Cut; Failure to Cut
A CUSTOMER REPORTED THAT THE PROBE COULD NOT CUT 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 23379529 ↗
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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