Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752450Recalls & reported problems
Alcon Laboratories, Inc. · 25+ TOTAL PLUS Combined Procedure Pak, Beveled 10,000 CPM ULTRAVIT Probe Straight Endoilluminator 0.9 mm Tipless Anterior Kit · Class 2
All models of Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon Constellation vitrectomy cutter is an instrument used in eye surgery. Many of its 1,170 reports describe the cutter failing to cut, along with suction problems and leaks. Some recent reports describe bent or deformed blades and replacing the device during surgery, with no patient impact noted. The reports include 33 injuries and no deaths. Two open recalls name this device, covering packaging damage that could affect sterility and blade sharpness complaints.
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
- 1,160
- Deaths reported
- 0
- Injuries reported
- 33
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 1,160 adverse event reports that list this exact device (DI 00380657524501), received between Sep 10, 2019 and Sep 30, 2026 — classified as 33 injuries, 1,127 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (722 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · 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-2678-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Cut722
- Suction Problem151
- Suction Failure100
- Leak/Splash58
- Fluid/Blood Leak30
- Break28
- Adverse Event Without Identified Device or Use Problem24
- Ambient Noise Problem24
Patient problems
- No Clinical Signs, Symptoms or Conditions918
- Insufficient Information217
- Endophthalmitis22
- Retinal Tear5
- Intraocular Pressure Decreased4
- Inflammation2
- Retinal Detachment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 1,160 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Cut
A Physician reported that cutting speed of the vitrectomy probe was low, making the cutting operation cannot be started normally 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 50946970 ↗MalfunctionSep 30, 2026Failure to Cut
A physician reported that probe had poor cutting during the vitrectomy surgery. The surgery was completed after replacing the product with another one. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50943208 ↗MalfunctionSep 30, 2026Suction Problem; Failure to Cut
A customer via health authority reported that vitrectomy probe was found to be blocked intraoperatively and could not perform 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 50943004 ↗MalfunctionSep 29, 2026Suction Problem
A non-healthcare professional reported via health authority that the tubing had no suction when using the pack during surgery. The surgery type was unknown. The surgery was completed on same day after replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933479 ↗MalfunctionSep 28, 2026Failure to Cut
A nurse reported that the cutter (vitrectomy probe) stopped functioning and could not function even after the cutter rate was reduced to 5000 cuts per minute (CPM) before cataract and vitrectomy combination surgery. The surgery was completed on same day after replacing with another one. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50917211 ↗MalfunctionSep 28, 2026Failure to Cut
A nurse reported that the cutter (vitrectomy probe) stopped functioning and could not function even after the cutter rate was reduced to 5000 cuts per minute (CPM) before cataract and vitrectomy combination surgery. The surgery was completed on same day after replacing with another one. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50917209 ↗MalfunctionSep 28, 2026Suction Problem
A physician reported that the cutter could not aspirate during surgery. The surgery was completed after replacing the product with another one. The procedure type was unknown. There was no impact occurred to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916953 ↗MalfunctionSep 28, 2026Leak/Splash
A Physician reported that cassette leak water before vitrectomy surgery. The surgery was successfully 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 50916528 ↗MalfunctionSep 28, 2026Suction Problem
A Physician reported that aspiration problem of cutter occurred during surgery. The Procedure type and replacement details were unknown. The surgery was completed on same day. There was no information about the patient impact.
Patient problems: Insufficient Information
MAUDE report 50911812 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported cutter did not cut during surgery. The procedure type was unknown. 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 50911178 ↗MalfunctionSep 25, 2026Failure to Cut; Ambient Noise Problem
A physician reported that vitrectomy probe generated an abnormal noise and had poor cutting, but the aspiration was good and reducing the cut rate did not improve the cutting efficiency during vitrectomy surgery. The surgery was completed on the same day after replacing the product with new one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896952 ↗MalfunctionSep 24, 2026Failure to Cut
A physician professional reported that the vitrectomy probe could not cut normally during 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 50881601 ↗MalfunctionSep 24, 2026Failure to Cut
A physician reported that the vitreous cutter was unable to cut in the middle of the surgery. The procedure type was unknown. 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 50880919 ↗MalfunctionSep 23, 2026Infusion or Flow Problem
A physician reported that pack was difficult to get water out of the infusion cannula during surgery. The procedure type was unknown. 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 50864870 ↗MalfunctionSep 23, 2026Failure to Cut
A non-healthcare professional reported via health authority that the vitrectomy cutter head stopped rotating during vitreous cutting procedure. The procedure was completed on same day by replacing the product with another one. There was no information reported about patient impact.
Patient problems: Insufficient Information
MAUDE report 50864412 ↗MalfunctionSep 22, 2026Failure to Cut
A non-healthcare professional reported that the vitrectomy probe could not cut during vitrectomy surgery. The surgery was completed on same day after replacing the same product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856716 ↗MalfunctionSep 22, 2026Suction Problem; Failure to Cut
A physician reported that the vitrectomy probe stopped cutting halfway and had weak aspiration during vitrectomy surgery. The surgery was completed on same day after replacing the pack with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851241 ↗MalfunctionSep 22, 2026Failure to Cut
A physician reported that probe had no cutting and aspiration was normal during vitrectomy surgery. The procedure was completed on the same day, but it was unknown how it got completed. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851170 ↗MalfunctionSep 22, 2026Failure to Cut
A physician reported that the cutter did not cut properly during surgery. The procedure type was unknown. 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 50850160 ↗MalfunctionAug 28, 2026Failure to Cut
A health care professional reported that the vitrectomy probe could not cut 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 50492948 ↗MalfunctionAug 28, 2026Failure to Cut
A physician reported that the vitrectomy probe had poor cutting before vitrectomy surgery. The surgery completed on the same day however the replacement details were unknown. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50492945 ↗MalfunctionAug 28, 2026Material Twisted/Bent
The physician reported that the probe shaft (tip) was bent 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, there was no impact on the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50489348 ↗MalfunctionAug 14, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50249819 ↗MalfunctionAug 13, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50235444 ↗MalfunctionAug 13, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50235074 ↗
Other Vitrectomy, instrument cutter devices
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752437Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls1,023 reports
- CONSTELLATION® HYPERVIT® TOTAL PLUS® 8065000095Alcon Laboratories, Inc. · Vitrectomy, instrument cutter2 recalls616 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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