Constellation, ULTRAVIT, EdgePlus, TotalPlusRecalls & reported problems across all models
Alcon Laboratories, Inc. · 2 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, EdgePlus, TotalPlus model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 269
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 1
We found 2 models of Constellation, ULTRAVIT, EdgePlus, TotalPlus by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 269 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2021 and Aug 14, 2026 — classified as 8 injuries, 261 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (196 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, EdgePlus, TotalPlus 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, EdgePlus, TotalPlus problems
Device problems
- Failure to Cut196
- Suction Problem36
- Suction Failure24
- Fluid/Blood Leak13
- Ambient Noise Problem9
- Leak/Splash5
- Air/Gas in Device4
- Break4
Patient problems
- No Clinical Signs, Symptoms or Conditions221
- Insufficient Information42
- Endophthalmitis3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Conjunctival Hemorrhage1
- Eye Injury1
- Intraocular Pressure Decreased1
- Laceration(s)1
Constellation, ULTRAVIT, EdgePlus, TotalPlus models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Constellation, ULTRAVIT, EdgePlus, TotalPlus 8065752448Unit, phacofragmentation1 recall206 reports
- Constellation, ULTRAVIT, EdgePlus, TotalPlus 8065752452Unit, phacofragmentation63 reports
Recent Constellation, ULTRAVIT, EdgePlus, TotalPlus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251388 ↗MalfunctionAug 14, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50249815 ↗MalfunctionAug 11, 2026Use of Device Problem
A non- healthcare professional reported that cutter in the surgical pack was not functioning and could not be used during vitrectomy surgery. The surgery was successfully completed on same day, but it was unknown how the surgery was completed. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50209225 ↗MalfunctionAug 10, 2026Fluid/Blood Leak
Patient problems: Insufficient Information
MAUDE report 50194558 ↗MalfunctionAug 10, 2026Failure to Cut
A nurse reported that the self-closing cannulae leaked fluid. The probe could not cut before the vitrectomy surgery. The surgery completed on same day but unknow how it was completed. No information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50194557 ↗MalfunctionAug 10, 2026Failure to Cut
A healthcare professional reported that probe would not be cut. The surgery type was vitrectomy surgery. The surgery was completed on same day. The other surgery details were unknown. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194556 ↗MalfunctionJun 4, 2026Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT PROBE DID NOT CUT AT DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED BY OPENING NEW PACK. THERE WAS PATIENT CONTACT DURING THE VITREOUS REMOVAL PHASE BUT NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 25388681 ↗MalfunctionMay 26, 2026Failure to Cut
A PHYSICIAN REPORTED THAT PROBE COULD NOT CUT BEFORE CATARACT/VITRECTOMY COMBINATION SURGERY. 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 25280344 ↗MalfunctionMay 15, 2026Failure to Cut
A PHYSICIAN REPORTED THAT PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO INFORMATION ABOUT THE PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25186083 ↗MalfunctionApr 2, 2026Suction Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT THERE WAS NO ASPIRATION FROM THE ANTERIOR VITRECTOMY CUTTER DESPITE FLUSHING THOUGH THE DEVICE DURING VITRECTOMY SURGERY. ANOTHER PACK WAS OPENED TO RETRIEVE THE ANTERIOR CUTTER WHICH WAS THEN PRIMED AND CASE PROCEEDED AS PLANNED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 24762726 ↗MalfunctionMar 5, 2026Failure to Cut
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS PERFORMED AND 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 24518754 ↗MalfunctionMar 4, 2026Improper Flow or Infusion
A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THERE WAS NO GAS OR WATER IN AND OUT FROM THE GAS-LIQUID EXCHANGE TUBE, WHICH CAUSED THE TEST TO FAIL BEFORE CATARACT AND VITRECTOMY COMBINATION 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 24505563 ↗MalfunctionMar 2, 2026Suction Problem; Failure to Cut
A HEALTHCARE PROFESSIONAL REPORTED THAT CUTTER NOT WORKING (CUTTING AND ASPIRATION WERE NOT WORKING) DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON SAME DAY BY REPLACING THE PAK. THE PRODUCT WAS CONTACTED WITH PATIENT, BUT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24481534 ↗InjuryFeb 23, 2026Leak/Splash
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT CASSETTE LEAKAGE OCCURRED DURING THE COMBINED CATARACT/VITRECTOMY PROCEDURE. THE SURGERY COULD NOT BE COMPLETED THE SAME DAY AND WAS RESCHEDULED THREE DAYS LATER, AFTER WHICH IT WAS COMPLETED. DETAILS REGARDING HOW THE SUBSEQUENT PROCEDURE WAS PERFORMED AND THE PATIENT¿S CURRENT CONDITION REMAIN UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 24411694 ↗MalfunctionFeb 20, 2026Break
A CUSTOMER REPORTED VIA HEALTH AUTHORITY THAT THE PROBE WAS BROKEN BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401051 ↗
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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