Constellation, Ultravit, 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
1 open recall names at least one Constellation, Ultravit, TotalPlus, EdgePlus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 461
- Deaths reported
- 0
- Injuries reported
- 13
- Recalls
- 1
We found 5 models of Constellation, Ultravit, TotalPlus, EdgePlus by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 461 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2021 and Sep 30, 2026 — classified as 13 injuries, 448 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (248 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, 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 ↗
Most reported Constellation, Ultravit, TotalPlus, EdgePlus problems
Device problems
- Failure to Cut248
- Fluid/Blood Leak67
- Suction Failure44
- Suction Problem41
- Leak/Splash33
- No Flow10
- Dull, Blunt8
- Fitting Problem8
Patient problems
- No Clinical Signs, Symptoms or Conditions386
- Insufficient Information71
- Intraocular Pressure Decreased4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Retinal Detachment2
- Foreign Body In Patient1
- Intraocular Pressure Increased1
- Retinal Tear1
Constellation, Ultravit, TotalPlus, EdgePlus models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751613Unit, phacofragmentation1 recall222 reports
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751765Unit, phacofragmentation1 recall208 reports
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751614Unit, phacofragmentation20 reports
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751766Unit, phacofragmentation10 reports
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751908Unit, phacofragmentation1 report
Recent Constellation, Ultravit, 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, 2026Use of Device Problem
A non-healthcare professional reported that cutter failed to operate during retinal surgery. The surgery was completed on the same day, after replacing the product with another one. There was no information about patient impact.Additional information was requested and non-received till date.
Patient problems: Insufficient Information
MAUDE report 50948318 ↗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 50943686 ↗MalfunctionSep 29, 2026Failure to Cut
A health care professional reported that the vitrectomy probes could not cut during cataract and vitrectomy combination surgery. The procedure was completed on same day by replacement with new ones. There was no information about any patient impact.
Patient problems: Insufficient Information
MAUDE report 50934795 ↗MalfunctionSep 27, 2026Use of Device Problem
Patient problems: Insufficient Information
MAUDE report 50910125 ↗MalfunctionSep 25, 2026Fluid/Blood Leak
A physician reported that the trocar valve leaked during a vitrectomy procedure. The procedure was completed on the same day after the product was replaced with a new trocar valve from a new pack. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895069 ↗MalfunctionSep 23, 2026Failure to Cut
A physician reported that vitrectomy probe could not cut 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 50870001 ↗MalfunctionSep 23, 2026Leak/Splash
A non-healthcare professional reported that the cassette exhibited a leak near the bag. The procedure type and other surgery details were unknown. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50868685 ↗MalfunctionSep 23, 2026Suction Problem
A physician reported that this report vitrectomy probe had no aspiration during vitrectomy surgery.The surgery was completed on the same day, but it was unknown how the surgery was completed.There was no information about the patient impact.
Patient problems: Insufficient Information
MAUDE report 50865176 ↗MalfunctionSep 23, 2026Leak/Splash
A customer reported via health authority that a leakage was observed in the cassette near the bag at unknown timing of surgery. The procedure type and procedure completion details were unknown, but the kit was replaced with another kit. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50864799 ↗MalfunctionAug 21, 2026Failure to Cut
A customer reported that there was a malfunction with cutter (vitrectomy probe) during a vitrectomy surgery. The aspiration function was good. To avoid any delay to the patient, a new cutter from the same lot was immediately opened and used. The replacement cutter functioned properly, and the surgery was completed successfully without further issues. There was no information about any patient impact.
Patient problems: Insufficient Information
MAUDE report 50373400 ↗MalfunctionAug 14, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50250758 ↗MalfunctionAug 11, 2026Failure to Cut
A physician reported that cutting function of the cutter was not functioning, only aspiration function remained functional during vitreoretinal surgery. The surgery was completed on the same day, after replacing the cutter with another one. There was no information about patient impact. Additional information was requested and non-received till date.
Patient problems: Insufficient Information
MAUDE report 50211327 ↗MalfunctionMar 5, 2026Fluid/Blood Leak
A PHYSICIAN REPORTED THAT LEAK WAS OBSERVED IMMEDIATELY UPON INSERTING THE TROCAR INTO THE EYE DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY REPLACING THE DEFECTIVE TROCAR WITH A NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518757 ↗MalfunctionMar 3, 2026Suction Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT CUTTER COULD NOT ASPIRATE DURING SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24493842 ↗MalfunctionFeb 19, 2026Suction Problem; Failure to Cut
A NURSE REPORTED THAT THE VITRECTOMY CUTTER HAD FUNCTIONED NORMALLY AT THE BEGINNING AND DID NOT CUT AND ASPIRATE DURING VITRECTOMY SURGERY. HOWEVER, THERE WAS AN EXPULSION OBSERVED THAT WAS NOT DUE TO ASPIRATION, AS ASPIRATION WAS NOT ACTIVE AT THAT TIME. 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 24388361 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page