Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT 8065752437Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,023 adverse event reports that list this exact device (DI 00380657524372), received between Mar 9, 2021 and Sep 30, 2026 — classified as 17 injuries, 1,006 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (642 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.

Recalls naming this device

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

Most reported problems

Recent adverse event reports

The 25 most recent of 1,023 reports, 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, 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, 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, 2026Failure to Cut

  A non-healthcare professional reported via the Health Authority that the vitrectomy probe had poor cutting during vitrectomy. 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 50933072 ↗
• MalfunctionSep 29, 2026Failure to Cut

  A physician reported that the cutter stopped working; aspiration remained functional, but cutting was not occurring during the middle of the vitrectomy surgery. The surgery was completed after replacing the product with new one. There was no impact on the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932502 ↗
• MalfunctionSep 29, 2026Leak/Splash

  A nurse reported that cassette leaked before the 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 50930524 ↗
• MalfunctionSep 29, 2026Failure to Cut

  A health care professional reported that while the surgeon was in the initial of core posterior vitrectomy surgery, the vitrectomy probe was not cutting, but however the aspiration function was normal. Eventually surgeon had to open another pak to complete the procedure. There was no information about any impact on patient.

  Patient problems: Insufficient Information

  MAUDE report 50930520 ↗
• MalfunctionSep 28, 2026Failure to Cut

  A physician reported that the cutter suddenly stopped actuating during surgery. The surgery was completed on the same day after replacing the product 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 50916951 ↗
• MalfunctionSep 28, 2026Suction Problem; Failure to Cut

  A physician reported that probe had poor cutting and aspiration even reduced the cutting rate below 3000 during the 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 50911939 ↗
• MalfunctionSep 25, 2026Suction Problem; Failure to Cut

  A physician reported that the probe was unable to cut and aspirate properly during vitrectomy surgery, even after the cutting speed was reduced to below 3,000 cuts per minute. 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 50895071 ↗
• MalfunctionSep 24, 2026Failure to Cut

  A nurse reported that probe was not cutting at an unknown timing. The procedure type was unknown. The surgery details and patient impact information was unknown.Additional information was received that probe was not cutting during vitrectomy surgery. The surgery was completed on the same day by opening the another vitrectomy pak. There was no patient impact.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885755 ↗
• MalfunctionSep 24, 2026Material Twisted/Bent

  A nurse reported that the vitrectomy probe was noted to be bent prior to use during pars plana vitrectomy, endo laser photocoagulation and silicone oil filling 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 50885266 ↗
• MalfunctionSep 24, 2026Failure to Cut; Ambient Noise Problem

  A physician reported that the vitrectomy probe had a hoarse sound. There was suction, but the cutting performance was very low, which affected the surgery. It still did not work even when the cutting speed was reduced to a lower level during vitrectomy surgery. The surgery was completed on same day after replacing the same product with another one. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50882834 ↗
• MalfunctionSep 24, 2026Obstruction of Flow; Infusion or Flow Problem

  A nurse reported that the infusion head was blocked and was unable to produce water during vitrectomy surgery. 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 50882605 ↗
• MalfunctionSep 24, 2026Improper Flow or Infusion

  A nurse reported that gas-liquid exchange was not available and there was no gas discharge during vitrectomy surgery. The surgery completion and patient impact details were unknown.

  Patient problems: Insufficient Information

  MAUDE report 50881600 ↗
• MalfunctionSep 24, 2026Suction Problem; Failure to Cut

  A Physician reported that Probe unable to cut and aspirate properly 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 50877648 ↗
• MalfunctionSep 23, 2026Break

  A physician reported that cutter needle was fragile and broke easily outside the eye during surgery. The procedure type was unknown. The surgery was completed on same day by replacing it with new product. There was no information reported about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50870000 ↗
• MalfunctionSep 23, 2026Failure to Cut

  A nurse reported that that vitrectomy probe could not cut even after reducing the speed to five thousand cuts per minute during vitrectomy surgery. The surgery was completed on same day, but it was unknown how the surgery was completed. There was no information reported about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50864987 ↗
• MalfunctionSep 22, 2026Infusion or Flow Problem

  A physician reported that perfusion could not be performed normally during vitrectomy surgery. The surgery was completed on the same day, after replacing the product with another one. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50854385 ↗
• MalfunctionSep 22, 2026Suction Problem

  A nurse reported that the blockage of the vitrectomy probe during vitrectomy surgery. 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 50850339 ↗
• MalfunctionSep 18, 2026Failure to Cut

  A non-healthcare professional reported that vitrector would not cut once in the patient¿s eye during vitrectomy surgery. It was unknown how the surgery was completed. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50818252 ↗
• MalfunctionSep 11, 2026Suction Problem; Failure to Cut; Ambient Noise Problem

  A physician reported that the vitrectomy probe had produced a hoarse sound, and there was aspiration, but the flow rate and cutting performance were very low during cataract and vitrectomy combination surgery. Even when the cutting speed was reduced to a lower level, it did not function properly. The surgery was completed on same day after replacing the vitrectomy probe with another one. There was no information about patient impact.

  Patient problems: Insufficient Information

  MAUDE report 50729773 ↗