Constellation, Ultravit, 25+, TotalPlus, EdgePlusRecalls & reported problems across all models
Alcon Laboratories, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one Constellation, Ultravit, 25+, TotalPlus, EdgePlus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 725
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls
- 4
We found 5 models of Constellation, Ultravit, 25+, TotalPlus, EdgePlus by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 725 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2021 and Sep 30, 2026 — classified as 11 injuries, 714 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (278 reports).
4 FDA recall records name at least one of these models by its device identifier, 4 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, EdgePlus 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 ↗
- Jul 15, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Z-2675-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jul 15, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Z-2674-2024 · Root cause: Process control · Recall details · FDA record ↗
- Jul 15, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.
Z-2673-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported Constellation, Ultravit, 25+, TotalPlus, EdgePlus problems
Device problems
- Failure to Cut278
- Fluid/Blood Leak97
- Suction Failure68
- Break64
- Leak/Splash48
- Suction Problem39
- No Flow23
- Complete Blockage20
Patient problems
- No Clinical Signs, Symptoms or Conditions613
- Insufficient Information123
- Retinal Detachment5
- Intraocular Pressure Decreased3
- Retinal Tear3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Abrasion2
- Corneal Edema2
Constellation, Ultravit, 25+, TotalPlus, EdgePlus models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Unit, phacofragmentation2 recalls398 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Unit, phacofragmentation2 recalls302 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751618Unit, phacofragmentation1 recall13 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751768Unit, phacofragmentation11 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751902Unit, phacofragmentation1 report
Recent Constellation, Ultravit, 25+, TotalPlus, EdgePlus 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; Failure to Cut
A nurse reported that cutter failed to cut and aspirate during the vitrectomy surgery. The surgery was completed by replacing the cutter. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943551 ↗MalfunctionSep 30, 2026Break
A healthcare professional reported that tip of the vitrectomy probe broke off inside the eye during surgery. The surgery type was unknown. The broken tip was successfully removed from the eye without further complications. The surgery completions details were unknown. There was no information about patient impact.Additional information was requested and non-received till date.
Patient problems: Insufficient Information
MAUDE report 50943104 ↗MalfunctionSep 29, 2026Failure to Cut
A physician reported that vitrectomy probe was unable to work normally during vitrectomy surgery. The surgery was completed on the same day after replacing the product with another one. There was no impact to the patient.Additional information received that the issue was the vitrectomy probe had no cutting and the aspiration was normal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927821 ↗MalfunctionSep 28, 2026Failure to Cut
A nurse reported that the cutter was not cut 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 50915635 ↗MalfunctionSep 25, 2026Improper Flow or Infusion
A physician reported that the fluid continuously flowed from the tubing with no air output; after repeated attempts, only a small amount of air was delivered during the air-fluid exchange for the vitrectomy surgery. The surgery was completed on same day after replacing the product with new one. There was no impact on the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896950 ↗MalfunctionAug 17, 2026Use of Device Problem
A health care professional reported that the cutter (vitrectomy probe) was not performing during vitrectomy surgery. The surgery was completed on same day. There was no information about any patient impact.Additional information has been requested but none received till date.
Patient problems: Insufficient Information
MAUDE report 50271405 ↗MalfunctionAug 17, 2026Failure to Cut
A Physician reported that when cutting the vitreous body during vitrectomy surgery, the vit probe cannot complete effective cutting and there is only aspiration. The surgery was completed on same day after replacing with a new one. The patient returned smoothly to the ward after completing the surgery.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50269233 ↗MalfunctionAug 12, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50224294 ↗MalfunctionAug 12, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50224293 ↗MalfunctionAug 12, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50224287 ↗MalfunctionAug 11, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50206363 ↗MalfunctionFeb 16, 2026Material Separation; Suction Problem
A CUSTOMER REPORTED THAT THE FAULTY (GLUED TOGETHER) PURGE HOSES, VACUUM DELIVERY COLLAPSED IN AN UNKNOWN TIMING OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT UNKNOWN HOW IT WAS COMPLETED. OTHER SURGERY DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT IMPACT TO THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 24360502 ↗MalfunctionJan 23, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE GOT BEND AND THEN DETACHED DURING SURGERY. PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24159071 ↗MalfunctionJan 12, 2026Fluid/Blood Leak
A PHARMACIST REPORTED THAT THE VALVED TROCARS BEGAN TO LEAK DURING CALIBRATION OF VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24033764 ↗MalfunctionJan 8, 2026Noise, Audible; Air/Gas in Device
A PHYSICIAN REPORTED THAT A STRANGE SOUND WAS HEARD FROM THE CASSETTE AND ALSO, AIR GOT INTO THE CASSETTE A LOT DURING 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 24000517 ↗
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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