Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVITRecalls & reported problems across all models

We found 8 models of Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 2,968 adverse event reports in the FDA's MAUDE database, received between Sep 10, 2019 and Sep 30, 2026 — classified as 88 injuries, 2,880 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (1,829 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 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.

1. 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 8 of these models · Recall details · FDA record ↗

2. 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-2679-2024 · Root cause: Process control · Recall details · FDA record ↗

3. 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 ↗

4. 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-2677-2024 · Root cause: Process control · Recall details · FDA record ↗

5. 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-2676-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT problems

Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752450

  Vitrectomy, instrument cutter
  2 recalls1,160 reports
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752437

  Vitrectomy, instrument cutter
  2 recalls1,023 reports
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752451

  Vitrectomy, instrument cutter
  2 recalls258 reports
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752438

  Vitrectomy, instrument cutter
  2 recalls203 reports
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752435

  Vitrectomy, instrument cutter
  1 recall126 reports
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752436

  Vitrectomy, instrument cutter
  1 recall79 reports
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752449

  Vitrectomy, instrument cutter
  1 recall61 reports
• Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752439

  Vitrectomy, instrument cutter
  1 recall58 reports

Recent Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Suction Problem; Failure to Cut

  A Physician reported that Probe had poor cutting and aspiration, and speed was slowed down during 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 50948064 ↗
• MalfunctionSep 30, 2026Improper Flow or Infusion

  A Nurse reported that Air-liquid exchange is not available, no air discharge was observed 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 50946972 ↗
• 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 non-health care professional reported that the vitrectomy cutter would barely cut and only aspirate during vitrectomy surgery. The surgery completed on the same day after multiple different cutters were attempted to be used. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944981 ↗
• MalfunctionSep 30, 2026Failure to Cut

  A healthcare professional reported that cutter did not cut during the vitrectomy surgery. The aspiration condition was normal. The other surgery details and patient impact details were unknown.Additional information requested and received that the surgery was completed by replacing the cutter. Theare was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943687 ↗
• MalfunctionSep 30, 2026Use of Device Problem

  A health care professional reported that cutter stopped working during macula surgery. The surgery was completed on the same day after replacing it with another product. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943431 ↗
• 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 30, 2026Suction Problem

  A physician reported that the cutter suction was low during vitrectomy surgery. The procedure was completed on same day after replacing the product with new one. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942545 ↗
• MalfunctionSep 29, 2026Improper Flow or Infusion

  A physician reported that unable to perform air-fluid exchange normally during vitrectomy surgery. The surgery was completed on the same day by changing with new product. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50936702 ↗
• MalfunctionSep 29, 2026Suction Problem; Failure to Cut

  A physician reported that vitrectomy probe was unable to cut and aspirate normally even after the cutting speed was reduced below 3000 cuts per minute during vitrectomy surgery. However, other accessories inside the package were normal. The surgery was successfully 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 50935043 ↗
• MalfunctionSep 29, 2026Failure to Cut

  A physician reported that during cataract and vitrectomy combination surgery, the vitrectomy probe did not actuate. Reducing the speed from 10,000 cuts per minute to 5,000 cuts per minute did not improve the situation. The procedure was completed on same day by replacing with same product. There was patient contact with suspect product but no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934803 ↗
• MalfunctionSep 29, 2026Improper Flow or Infusion

  A physician reported that there was failure of air/fluid exchange 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 50934792 ↗
• MalfunctionSep 29, 2026Suction Problem; Ambient Noise Problem

  A nurse reported that the vitrectomy probe had abnormal noise and no negative pressure 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 50934791 ↗
• 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 ↗

Other Alcon Laboratories, Inc. products

• Clareon1,142 models · 8,100 reports · 1 recall
• 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
• ClearCut17 models · 531 reports · 13 recalls