CONSTELLATION HYPERVIT ENGAUGERecalls & reported problems across all models
Alcon Laboratories, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 195
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 4 models of CONSTELLATION HYPERVIT ENGAUGE by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 195 adverse event reports in the FDA's MAUDE database, received between Apr 9, 2021 and Sep 30, 2026 — classified as 5 injuries, 190 malfunctions.
The most frequently reported specific device problem is “Failure to Cut” (149 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. 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
Reports received per month, all models
Most reported CONSTELLATION HYPERVIT ENGAUGE problems
Device problems
- Failure to Cut149
- Suction Problem34
- Suction Failure16
- Ambient Noise Problem7
- Noise, Audible2
- Adverse Event Without Identified Device or Use Problem1
- Air/Gas in Device1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions151
- Insufficient Information40
- Retinal Tear3
- Retinal Detachment2
- Intraocular Pressure Decreased1
CONSTELLATION HYPERVIT ENGAUGE models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CONSTELLATION HYPERVIT ENGAUGE 8065830026Vitrectomy, instrument cutter137 reports
- CONSTELLATION HYPERVIT ENGAUGE 8065830027Vitrectomy, instrument cutter55 reports
- CONSTELLATION® HYPERVIT® ENGAUGE® 8065830022Vitrectomy, instrument cutter2 reports
- CONSTELLATION® HYPERVIT® ENGAUGE® 8065830023Vitrectomy, instrument cutter1 report
Recent CONSTELLATION HYPERVIT ENGAUGE adverse event reports
The 15 most recent reports across all models, 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 50797379 ↗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 ↗InjurySep 4, 2026Failure to Cut
A physician reported that the vitreous was not being adequately cut. After the cutter was replaced, the issue was resolved. During peripheral retinal examination following vitrectomy, two retinal tears were identified in the inferior peripheral retina. During intraoperative laser treatment, No retinal detachment was observed. Treatment was completed with laser.
Patient problems: Retinal Tear
MAUDE report 50613744 ↗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 13, 2026Suction Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234796 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- 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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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