CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000095Recalls & reported problems
Alcon Laboratories, Inc. · 25+®Ga HYPERVIT® Bevel 20K CPM TOTAL PLUS® Combined Procedure Pak · Class 2
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is an Alcon Constellation Hypervit Total Plus vitrectomy cutter. Most of the 623 reports describe the cutter failing to cut or suction during surgery, and several say the operation was finished after switching to a new unit. There are no deaths and 17 injuries. There are 2 open recalls: one for possible damage to the packaging seal of some lots that could compromise sterility, and one over complaints about the sharpness of certain eye knives.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 616
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 616 adverse event reports that list this exact device (DI 00380650000958), received between May 11, 2021 and Sep 30, 2026 — classified as 17 injuries, 599 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (433 reports).
2 FDA recall records name this device's identifier, 2 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- 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 · 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 · FDA record ↗
Most reported problems
Device problems
- Failure to Cut433
- Suction Problem83
- Suction Failure65
- Ambient Noise Problem21
- Leak/Splash19
- Adverse Event Without Identified Device or Use Problem13
- Fluid/Blood Leak11
- Break9
Patient problems
- No Clinical Signs, Symptoms or Conditions498
- Insufficient Information114
- Endophthalmitis12
- Intraocular Pressure Decreased4
- Retinal Tear2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 616 reports, in the reporter's own words as published by the FDA.
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 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 ↗MalfunctionSep 29, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928547 ↗MalfunctionSep 29, 2026Failure to Cut
A physician reported that the probe gradually stopped cutting during vitrectomy surgery. The surgery was completed on the same day after replacing the product with another one. There was no impact occurred to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927883 ↗MalfunctionSep 28, 2026Failure to Cut
A Physician reported that probe could not cut during vitrectomy surgery. The surgery was successfully 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 50916524 ↗MalfunctionSep 28, 2026Failure to Cut
A healthcare professional reported that the vitrectomy probe could not cut even reduced the cutting speed 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915640 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported that probe gradually stopped cutting and could not be used during vitrectomy surgery. The surgery was completed after replacing it with another product. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914012 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported that the vitrectomy probe gradually lost cutting 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 50911725 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported that cutting problem of cutter occurred during surgery. The procedure type was unknown. The surgery was completed on the same day after replacing with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911541 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported that the vitrectomy probe gradually stopped cutting 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 50911179 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported that an actuation issue with the cutter occurred during surgery. The surgery was completed on the same day after the product was replaced with another one. The procedure type was unknown. There was patient contact with the suspect product; however, no impact occurred to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910958 ↗MalfunctionSep 22, 2026Suction Problem
A physician reported that poor aspiration of the cutter occurred during surgery. The procedure type was unknown. The surgery was completed on same day after replacing the product with another one. There was no patient contact with the product.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851242 ↗MalfunctionSep 22, 2026Obstruction of Flow
A physician reported that the aspiration tubing of the vitrectomy probe was blocked and could not be used before vitrectomy surgery. The surgery was completed on the same day, and it was unknown how the surgery was completed. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50850539 ↗MalfunctionAug 14, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50250658 ↗MalfunctionAug 12, 2026Infusion or Flow Problem
A healthcare professional reported that the infusion head was blocked before vitrectomy surgery. The surgery was completed on the same day. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217275 ↗MalfunctionAug 11, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50208852 ↗MalfunctionAug 11, 2026Failure to Cut; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50205620 ↗MalfunctionAug 11, 2026Failure to Cut
A nurse reported that vitrectomy probe could not cut even after reduced cutting speed 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 50204792 ↗MalfunctionAug 10, 2026Failure to Cut
A physician reported that the cutter actuation failure occurred during surgery. The procedure type was unknown. 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 50194784 ↗MalfunctionJul 31, 2026Failure to Cut
A physician reported that cutter¿s cuts per minute speed did not increase during 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 50095898 ↗MalfunctionMay 29, 2026Suction Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT ASPIRATION ISSUE OF THE CUTTER BEFORE SURGERY. THE PROCEDURE TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 25332740 ↗MalfunctionMay 27, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE CUTTER WAS NOT PROPERLY ASPIRATED DURING SURGERY. REPLACED ONLY THE CUTTER DID NOT IMPROVE, AND THE PACK WAS REPLACED, THE SURGERY WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25311689 ↗
Other Vitrectomy, instrument cutter devices
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752450Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls1,160 reports
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752437Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls1,023 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753106Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls546 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000096Alcon Laboratories, Inc. · Vitrectomy, instrument cutter1 recall554 reports
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752451Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls258 reports
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752438Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls203 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065753109Alcon Laboratories, Inc. · Vitrectomy, instrument cutter1 recall223 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065830077Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls159 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.