Constellation, ULTRAVIT, Engauge, 25+ 8065752415Recalls & reported problems
Alcon Laboratories, Inc. · 25+* ULTRAVIT* Vitrectomy Probe Beveled 25+* /10,000 CPM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Constellation Ultravit vitrectomy probe is a surgical tool used to cut and remove material during eye surgery. Its 386 reports include 1 injury and no deaths, and mostly describe the probe failing to cut, with weak suction in some. Many reports say the surgery was finished after the surgeon swapped in a new probe. No recalls name this device.
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
- 369
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 369 adverse event reports that list this exact device (DI 00380657524150), received between Mar 2, 2021 and Sep 30, 2026 — classified as 1 injury, 368 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (266 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut266
- Suction Problem65
- Suction Failure34
- Break8
- Complete Blockage6
- Air/Gas in Device5
- Material Twisted/Bent5
- Fitting Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions334
- Insufficient Information34
- Bone Cement Implantation Syndrome1
- Vitreous Hemorrhage1
Recent adverse event reports
The 25 most recent of 369 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Cut
A Nurse reported that probe had poor cutting during vitrectomy surgery. The surgery was successfully completed on the same day; however, details regarding the completion of the procedure were not available. There was no impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942636 ↗MalfunctionSep 29, 2026Failure to Cut
A nurse reported that the probe had poor cutting during the vitrectomy surgery. The surgery was completed on same day. The other surgery details and patient impact details were unknown.
Patient problems: Insufficient Information
MAUDE report 50928956 ↗MalfunctionSep 29, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50928545 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported that the cutting speed of the vitrectomy probe was slow and could not reach ten thousand cuts per minute during vitrectomy surgery. The surgery was completed on the same day after replacing the product with a new one. There was no patient impact.This case pertains to the one of two probes reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911629 ↗MalfunctionSep 28, 2026Failure to Cut
A physician reported that the cutting speed of the vitrectomy probe was slow and could not reach ten thousand cuts per minute during vitrectomy surgery. The surgery was completed on the same day after replacing the product with a new one. There was no patient impact.This case pertains to the one of two probes reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911617 ↗MalfunctionSep 23, 2026Failure to Cut
A physician reported that probe has no aspiration during the vitrectomy surgery. The surgery was completed on same day by replacing the product. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866432 ↗MalfunctionSep 23, 2026Failure to Cut
A nurse reported that the vitrectomy probe had poor 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 50864873 ↗MalfunctionSep 23, 2026Failure to Cut
A nurse reported that the vitrectomy probe had poor 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 50864798 ↗MalfunctionSep 23, 2026Failure to Cut
A physician reported that the vitrectomy probe gradually stopped cutting 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 50864353 ↗MalfunctionSep 22, 2026Failure to Cut
A physician reported that vitrectomy 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 patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853453 ↗MalfunctionSep 22, 2026Failure to Cut
A physician reported that the vitrectomy probe gradually stopped cutting during vitrectomy surgery. The procedure was completed on same day after replacement of product with new one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50851431 ↗MalfunctionSep 18, 2026Failure to Cut
A nurse reported that the vitrectomy probe had poor cutting during vitrectomy surgery. The probe could not completely cut off the vitreous body. The surgery was completed on same day, and it was unknown how the surgery was completed. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818239 ↗MalfunctionAug 28, 2026Failure to Cut
A healthcare professional reported that vitrectomy probe had only aspiration and there was no cutting before vitrectomy surgery. The surgery was successfully completed on same day by replacing it with new product. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50493334 ↗MalfunctionAug 26, 2026Failure to Cut
A physician reported that vitrectomy probe had poor cutting 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.This report pertains to the first of the two probes involved in the complaint.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50443878 ↗MalfunctionAug 24, 2026Suction Problem
A healthcare professional reported that probe had poor aspiration before vitrectomy surgery. The procedure was completed on same day but details were unknown. There was no information about patient impact at the time of reporting.
Patient problems: Insufficient Information
MAUDE report 50407734 ↗MalfunctionAug 14, 2026Suction Problem
Patient problems: Insufficient Information
MAUDE report 50251250 ↗MalfunctionAug 13, 2026Failure to Cut
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50232500 ↗MalfunctionAug 12, 2026Failure to Cut
A physician reported that the vitrectomy probe had poor cutting, while aspiration was normal during the vitrectomy surgery. The surgery was completed on the same day after replacing the product with a new one. There was no impact on the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50221613 ↗MalfunctionAug 12, 2026Suction Problem
Patient problems: Insufficient Information
MAUDE report 50219810 ↗MalfunctionAug 12, 2026Failure to Cut
Patient problems: Insufficient Information
MAUDE report 50218881 ↗MalfunctionAug 10, 2026Failure to Cut
A nurse reported that during vitrectomy surgery, the vitrectomy probes could not cut the vitreous body. The surgery was completed on the same day. There was no impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192443 ↗MalfunctionAug 10, 2026Failure to Cut
A nurse reported that during vitrectomy surgery, the vitrectomy probes could not cut the vitreous body. The surgery was completed on the same day. There was no impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192437 ↗MalfunctionMay 29, 2026Failure to Cut
A NURSE REPORTED THAT PROBE HAD POOR CUTTING DURING VITRECTOMY SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25328498 ↗MalfunctionMay 20, 2026Failure to Cut
A PHYSICIAN REPORTED THAT THE VITRECTOMY COULD NOT CUT DURING CALIBRATION. THE PROCEDURAL TYPE WAS UNKNOWN. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE SAME PRODUCT. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 25226553 ↗MalfunctionMay 19, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE PROBE HAD NO ASPIRATION AFTER BEING CONNECTED TO THE CONSOLE PRIOR TO VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25212399 ↗
Other Unit, phacofragmentation devices
- Centurion 8065751763Alcon Laboratories, Inc. · Unit, phacofragmentation728 reports
- Centurion 8065753057Alcon Laboratories, Inc. · Unit, phacofragmentation639 reports
- CENTURION® 8065752914Alcon Laboratories, Inc. · Unit, phacofragmentation571 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751617Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls398 reports
- Alcon 8065752201Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall386 reports
- Alcon 8065752200Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall366 reports
- Constellation, Ultravit, 25+, TotalPlus, EdgePlus 8065751767Alcon Laboratories, Inc. · Unit, phacofragmentation2 recalls302 reports
- Constellation, Ultravit, TotalPlus, EdgePlus 8065751613Alcon Laboratories, Inc. · Unit, phacofragmentation1 recall222 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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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