CONSTELLATION HYPERVIT TOTAL PLUSRecalls & 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 HYPERVIT TOTAL PLUS model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,098
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls
- 4
We found 5 models of CONSTELLATION HYPERVIT TOTAL PLUS by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 2,098 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2021 and Sep 30, 2026 — classified as 55 injuries, 2,043 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (1,405 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 HYPERVIT TOTAL PLUS 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-2108-2025 · Root cause: Under Investigation by firm · names 5 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-2680-2024 · 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-2671-2024 · 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-2647-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported CONSTELLATION HYPERVIT TOTAL PLUS problems
Device problems
- Failure to Cut1,405
- Suction Problem297
- Suction Failure192
- Ambient Noise Problem68
- Break52
- Leak/Splash52
- Material Twisted/Bent41
- Fluid/Blood Leak36
Patient problems
- No Clinical Signs, Symptoms or Conditions1,681
- Insufficient Information391
- Endophthalmitis18
- Intraocular Pressure Decreased16
- Retinal Tear11
- Retinal Detachment5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- Eye Injury4
CONSTELLATION HYPERVIT TOTAL PLUS models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000095Vitrectomy, instrument cutter2 recalls616 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753106Vitrectomy, instrument cutter2 recalls546 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000096Vitrectomy, instrument cutter1 recall554 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753109Vitrectomy, instrument cutter1 recall223 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065830077Vitrectomy, instrument cutter2 recalls159 reports
Recent CONSTELLATION HYPERVIT TOTAL PLUS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Incomplete or Inadequate Connection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949933 ↗MalfunctionSep 30, 2026Failure to Cut
A physician reported that probe had poor cutting 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 50946347 ↗MalfunctionSep 30, 2026Failure to Cut
A physician cutter could not cut during the surgery. The procedure type was unknown. 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 50945172 ↗MalfunctionSep 30, 2026Obstruction of Flow
A health care professional reported that the clogging before vitrectomy surgery. The surgery was completed on the same day however the replacement details were unknown. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50945171 ↗MalfunctionSep 30, 2026Failure to Cut
A non-health care professional 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 50944793 ↗MalfunctionSep 30, 2026Failure to Cut
A non-healthcare professional reported that packs (probes) were experiencing inconsistent vitrectomy cutting. The surgery details and patient impact details were unknown.
Patient problems: Insufficient Information
MAUDE report 50943555 ↗MalfunctionSep 30, 2026Suction Problem
A non healthcare professional reported that no fluid dynamic/aspiration with cutter at unknown timing. The procedure type and completion details were unknown. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50943553 ↗MalfunctionSep 30, 2026Failure to Cut
A non-healthcare professional reported that packs (probes) were experiencing inconsistent vitrectomy cutting. The surgery details and patient impact details were unknown.
Patient problems: Insufficient Information
MAUDE report 50943552 ↗MalfunctionSep 30, 2026Failure to Cut
A physician reported that the vitrectomy probe cutting speed was reduced during vitrectomy surgery. The surgery was completed after replacement of product with new one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943428 ↗MalfunctionSep 30, 2026Failure to Cut; Ambient Noise Problem
A non-healthcare professional reported that the vitrectomy probes were making weird noises and not cutting at an unknown timing. The surgery type, procedure completion details were unknown. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50943105 ↗MalfunctionSep 30, 2026Failure to Cut
A healthcare professional reported that the vitrector stopped cutting during vitrectomy surgery. In order to continue the operation, the doctor ordered to open another cassette, In total, there were two with the failure and one to be able to complete the surgery. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50943065 ↗MalfunctionSep 30, 2026Use of Device Problem
A healthcare professional reported via health authority that the cutter failed to operate during vitrectomy surgery. The procedure was completed on same day by replacing it with a new unit of the same type. There was no information reported about patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942544 ↗MalfunctionSep 29, 2026Use of Device Problem
A physician reported that the vitrectomy probe did not work during vitrectomy surgery. The surgery was completed on 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 50934801 ↗MalfunctionSep 29, 2026Insufficient Device Problem Information
A nurse reported that the cutter (vitrectomy probe) did not work on machine during surgery. The surgery type, procedure completion details were unknown. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50933483 ↗MalfunctionSep 29, 2026Failure to Cut
A nurse reported that the vitrectomy probe exhibited low cutting efficiency and was unable to completely cut the tissue during the vitrectomy surgery. The surgery was completed on the same day after replacing the product with new one. There was no impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932587 ↗
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
- 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
- ClearCut17 models · 531 reports · 13 recalls
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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