Constellation, Ultravit, TotalPlus, EngaugeRecalls & reported problems across all models
Alcon Laboratories, Inc. · 4 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, TotalPlus, Engauge model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 380
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 1
We found 4 models of Constellation, Ultravit, TotalPlus, Engauge by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 380 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2021 and Feb 27, 2026 — classified as 3 injuries, 377 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (168 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, 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 · names 2 of these models · Recall details · FDA record ↗
Most reported Constellation, Ultravit, TotalPlus, Engauge problems
Device problems
- Failure to Cut168
- Fluid/Blood Leak55
- Leak/Splash36
- Suction Problem35
- Suction Failure34
- No Flow15
- Air/Gas in Device12
- Break11
Patient problems
- No Clinical Signs, Symptoms or Conditions345
- Insufficient Information36
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Intraocular Pressure Decreased2
- Capsular Bag Tear1
- Visual Impairment1
Constellation, Ultravit, TotalPlus, Engauge models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Constellation, Ultravit, TotalPlus, Engauge 8065751058Unit, phacofragmentation1 recall215 reports
- Constellation, Ultravit, TotalPlus, Engauge 8065751077Unit, phacofragmentation1 recall162 reports
- Constellation, Ultravit, TotalPlus, Engauge 8065751079Unit, phacofragmentation2 reports
- Constellation, Ultravit, TotalPlus, Engauge 8065751063Unit, phacofragmentation1 report
Recent Constellation, Ultravit, TotalPlus, Engauge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Suction Problem
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH SAME PRODUCT. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469221 ↗MalfunctionFeb 5, 2026Failure to Cut
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE COULD NOT CUT 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 24268047 ↗MalfunctionJan 26, 2026Suction Problem; Failure to Cut
A NURSE REPORTED THAT THE VITREOUS PROBE STOPPED CUTTING MIDWAY AND COULD NOT ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24175995 ↗MalfunctionJan 14, 2026Failure to Cut
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AFTER INSERTING THE VIT PROBE INTO THE EYE, INTERMITTENT INCOMPLETE CUTTING WAS OBSERVED. THE VIT PROBE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24065117 ↗MalfunctionJan 13, 2026Failure to Cut; Air/Gas in Device
A NURSE REPORTED THAT THE PROBE SPIT BUBBLES AND THE CUTTER OF THE PROBE COULD NOT BE CLOSED AFTER OPENED, MAKING IT IMPOSSIBLE TO COMPLETE THE CUTTING 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 24051981 ↗MalfunctionJan 12, 2026Failure to Cut
A CUSTOMER REPORTED THAT PROBE COULD NOT CUT HALFWAY AND ASPIRATION WAS GOOD DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY CHANGING WITH PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24044915 ↗MalfunctionJan 12, 2026Suction Problem; Failure to Cut
A NURSE REPORTED THAT THE PROBE STOPPED CUTTING AND WAS UNABLE TO ASPIRATE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24034243 ↗MalfunctionDec 25, 2025Material Twisted/Bent; Material Twisted/Bent
A PHYSICIAN REPORTED THAT TIP OF THE VITRECTOMY PROBE WAS DEFORMED AND COULD NOT BE USED BEFORE VITRECTOMY SURGERY THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PACK WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23894537 ↗MalfunctionDec 9, 2025Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBE WAS UNABLE TO CUT PROPERLY DURING CATARACT AND VITRECTOMY COMBINATION 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 23755429 ↗MalfunctionDec 5, 2025Suction Problem; Failure to Cut; Suction Problem; Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY PROBE HAD NO ASPIRATION AND NO CUTTING 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 23726035 ↗MalfunctionDec 4, 2025Suction Problem; Air/Gas in Device; Suction Problem; Air/Gas in Device
A NURSE REPORTED THAT PROBE WAS BUBBLING AND NO ASPIRATION 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 23714114 ↗MalfunctionDec 3, 2025Suction Problem; Suction Problem
A NURSE REPORTED THAT THE PROBE HAS NO ASPIRATION BEFORE VITRECTOMY SURGERY. 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 23702069 ↗MalfunctionNov 24, 2025Failure to Cut; Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE COULD NOT CUT NORMALLY DURING 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 23628529 ↗MalfunctionNov 17, 2025Suction Problem; Suction Problem
A PHYSICIAN REPORTED THAT PROBE COULD NOT ASPIRATE 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 23569431 ↗MalfunctionNov 7, 2025Suction Problem; Suction Problem
A NURSE REPORTED THAT THE VITRECTOMY PROBE COULD CUT BUT ASPIRATION WAS ABNORMAL 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 23494540 ↗
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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