CONSTELLATION HYPERVIT ENGAUGE 8065830026Recalls & reported problems
Alcon Laboratories, Inc. · CONSTELLATION 25+ HYPERVIT Bevel, Vitrectomy Probe 20,000 cpm · Class 2
All models of CONSTELLATION HYPERVIT ENGAUGE (4)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Constellation Hypervit vitrectomy probe is used in eye surgery to cut and remove tissue. Its 149 reports mostly describe the probe cutting poorly or failing to cut during surgery, and some mention suction problems. The reports include 3 injuries and no deaths. Reports rose to 81 in the last 12 months from 40 in the 12 months before. 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
- 137
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 137 adverse event reports that list this exact device (DI 00380658300265), received between Aug 13, 2021 and Sep 30, 2026 — classified as 3 injuries, 134 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (111 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Cut111
- Suction Problem22
- Ambient Noise Problem7
- Suction Failure7
- Air/Gas in Device1
- Defective Device1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions99
- Insufficient Information36
- Retinal Detachment2
- Retinal Tear2
Recent adverse event reports
The 25 most recent of 137 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Cut
A physician reported that the vitrectomy probe did not cut during vitrectomy surgery. The procedure was completed on same day after replacement of product with new one. There was patient impact but details were unknown.
Patient problems: Insufficient Information
MAUDE report 50943558 ↗MalfunctionSep 30, 2026Failure to Cut
A customer reported that cutters would barely cut and only aspirate during vitrectomy surgery. The surgery completion and replacement details were unknown. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943347 ↗MalfunctionSep 30, 2026Failure to Cut
A physician reported that the cutter could not cut 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 impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943276 ↗MalfunctionSep 28, 2026Failure to Cut
A non-health care professional reported that probe would stop cutting after a couple minutes into surgery. The surgery details and patient impact were unknown.
Patient problems: Insufficient Information
MAUDE report 50915984 ↗MalfunctionSep 24, 2026Obstruction of Flow
A nurse reported the clear tubing of this cutter probe was occluded during vitrectomy surgery. The surgery was completed on the same day by replacing the product with another one. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50877275 ↗MalfunctionSep 22, 2026Suction Problem
A nurse reported that weak vacuum was observed during vitrectomy surgery. The product was replaced with a new unit, and the surgery was completed successfully. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852202 ↗MalfunctionSep 21, 2026Failure to Cut
A physician reported that the probe had poor cutting during vitrectomy surgery. The procedure was completed on same day, after replacing the product with another one. There was patient impact. The current condition of the patient was unknown.
Patient problems: Insufficient Information
MAUDE report 50840073 ↗MalfunctionSep 17, 2026Failure to Cut
A nurse reported that that vitrectomy probe could not cut 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 50797343 ↗MalfunctionSep 17, 2026Failure to Cut
A physician reported that that vitrectomy probe could not cut normally even after reducing speed during vitrectomy surgery. The surgery was completed on same day by replacing it with a new vitrectomy probe. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50797339 ↗MalfunctionSep 9, 2026Failure to Cut
A nurse reported that a vitrectomy probe had poor cutting before vitrectomy surgery. The procedure type was unknown. The procedure was completed on same day but completion details were unknown. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50686358 ↗MalfunctionSep 7, 2026Suction Problem
Patient problems: Insufficient Information
MAUDE report 50647235 ↗MalfunctionSep 3, 2026Failure to Cut
A nurse reported that the single use vitrectomy probes could not cut before vitrectomy surgery. The surgery was completed on same day. There was no information about any patient impact.
Patient problems: Insufficient Information
MAUDE report 50581437 ↗MalfunctionAug 11, 2026Incorrect, Inadequate or Imprecise Result or Readings; Insufficient Device Problem Information
A non-healthcare professional reported via health authority that vitrectomy probe was not be recognized and could not be used during surgery. The procedure type was unknown. The surgery was completed on 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 50211538 ↗MalfunctionAug 11, 2026Suction Problem
A health care professional reported that probe had poor aspiration before vitrectomy surgery. The procedure completion details were unknown. There was no information about patient impact.
Patient problems: Insufficient Information
MAUDE report 50206229 ↗MalfunctionJul 28, 2026Failure to Cut; Ambient Noise Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50051745 ↗MalfunctionJul 7, 2026Suction Problem
A NURSE REPORTED THAT VITRECTOMY PROBE HAD POOR ASPIRATION BEFORE 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 25742803 ↗MalfunctionJul 6, 2026Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 25716858 ↗MalfunctionJul 3, 2026Failure to Cut
A NURSE REPORTED THE VITRECTOMY PROBE COULD NOT CUT DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25703345 ↗MalfunctionJul 1, 2026Failure to Cut
A HEALTH CARE PROFESSIONAL REPORTED THAT THE VITRECTOMY PROBE HAD POOR CUTTING BEFORE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT IT WAS UNKNOWN HOW THE SURGERY WAS COMPLETED. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 25686499 ↗MalfunctionJun 29, 2026Failure to Cut
A PHYSICIAN REPORTED THAT CUTTER WAS NOT ROTATING AS PER INTENDED SPEED DURING 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 25658612 ↗MalfunctionJun 28, 2026Failure to Cut
A PHYSICIAN REPORTED THAT THE PROBE HAD POOR CUTTING PERFORMANCE 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 25647946 ↗MalfunctionMay 14, 2026Suction Problem
A PHYSICIAN REPORTED THAT VITRECTOMY PROBE COULD NOT ASPIRATE BEFORE THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY BUT REPLACEMENT DETAILS WERE UNKNOWN. THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25168344 ↗MalfunctionMay 13, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE VITRECTOMY PROBES (SINGLE USE CONSUMABLE) COULD NOT ASPIRATE BEFORE VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT PERTAINS TO FOUR VITRECTOMY PROBES INVOLVED IN REPORTED EVENT FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157157 ↗MalfunctionApr 29, 2026Suction Problem
A PHYSICIAN REPORTED THAT THE PROBE HAD NO ASPIRATION 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 25032990 ↗MalfunctionMar 12, 2026Failure to Cut
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE PROBES WOULD NOT CUT DURING THE SURGERY. THE DETAILS OF THE COMPLETED PROCEDURE WERE UNKNOWN. THE TYPE OF PROCEDURE WAS UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT
Patient problems: Insufficient Information
MAUDE report 24585367 ↗
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® 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
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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