Engauge, VektorRecalls & reported problems across all models
Alcon Laboratories, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 3 models of Engauge, Vektor by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Dec 24, 2021 and Apr 22, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (22 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 Engauge, Vektor problems
Device problems
- Fitting Problem22
- Defective Component5
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
- Defective Device1
- Failure to Cut1
- Failure to Fire1
- Output below Specifications1
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Insufficient Information7
Engauge, Vektor models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Engauge, Vektor 8065752556Instrument, vitreous aspiration and cutting, ac-powered18 reports
- Engauge, Vektor 8065752555Instrument, vitreous aspiration and cutting, ac-powered10 reports
- Engauge, Vektor 8065752554Instrument, vitreous aspiration and cutting, ac-powered1 report
Recent Engauge, Vektor adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2026Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE DID NOT FIT THROUGH THE TROCAR CANULA. THE SURGERY WAS COMPLETED ON THE SAME DAY CAUSING NO IMPACT ON PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953541 ↗MalfunctionDec 26, 2025Defective Component; Defective Component
A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT INSERT INTO TROCAR DURING SURGERY. THE PROCEDURE TYPE WAS NOT REPORTED. NO PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23895660 ↗MalfunctionDec 12, 2025Defective Component; Defective Component
A NURSE REPORTED THAT DURING THE VITRECTOMY SURGERY, OPHTHALMIC LASER PROBE COULD NOT GO THROUGH THE TROCAR CANNULA, BUT VITRECTOMY PROBE COULD GO THROUGH THE CANNULA. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER LASER PROBE. PATIENT IMPACT HAS NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23790200 ↗MalfunctionDec 5, 2025Defective Component; Defective Component
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE COULD NOT BE ADVANCED INTO THE TROCAR CANNULA. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING REPLACEMENT. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23726083 ↗MalfunctionSep 3, 2025Fitting Problem; Fitting Problem
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC LASER PROBE WOULD NOT FIT INTO THE TROCAR. THE PROCEDURE WAS COMPLETED BY USING ANOTHER PROBE WITHOUT PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22949335 ↗MalfunctionJun 9, 2025Defective Component; Defective Component
A CUSTOMER REPORTED THAT THE DURING VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE COULD NOT GET INTO THE PUNCTURE SYSTEM. THE SURGERY WAS COMPLETED BY USING NEW PRODUCT. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22165443 ↗MalfunctionJun 3, 2025Fitting Problem; Fitting Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY, OPHTHALMIC PROBE CANNOT BE INSERTED INTO THE PUNCTURE SYSTEM. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE NEW ONE. THE PATIENT IMPACT HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 22131628 ↗MalfunctionApr 24, 2025Fitting Problem; Material Twisted/Bent; Fitting Problem; Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING CALIBRATION OF AN OPHTHALMIC LASER PROBE TIP WAS BENT AND DID NOT FIT INTO THE TROCAR. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21897122 ↗MalfunctionApr 18, 2025Fitting Problem; Fitting Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT A LASER PROBE TIP THAT COULD NOT ENTER INTO TROCAR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER A NEW REPLACEMENT WAS USED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21864662 ↗MalfunctionFeb 18, 2025Fitting Problem; Fitting Problem
A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE TIP WAS BENT AND DID NOT FIT INTO TROCAR VALVE DURING SURGERY. SURGERY WAS COMPLETED AFTER REPLACING THE PROBE WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED. PROCEDURE DETAILS HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21400652 ↗MalfunctionFeb 3, 2025Fitting Problem; Fitting Problem
A PHYSICIAN REPORTED THAT IN AN OPHTHALMIC LASER PROBE, THE TIP DID NOT FIT INTO THE PORT DURING SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21297998 ↗MalfunctionJan 8, 2025Fitting Problem; Fitting Problem
A PHYSICIAN REPORTED THAT THE OPHTHALMIC LASER PROBE GOT STUCK INSIDE TROCAR DURING CATARACT / VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21099725 ↗MalfunctionNov 8, 2024Fitting Problem; Fitting Problem
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY A LASER PROBE WAS ALMOST IMPOSSIBLE TO GET INSIDE THE TROCAR. THE SURGERY WAS COMPLETED WITH NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639020 ↗MalfunctionSep 4, 2024Failure to Fire; Failure to Fire
A NURSE REPORTED THAT THE OPHTHALMIC LASER PROBE WAS NOT DELIVERING LASER ENERGY AND THAT NO LASER SPOT WAS VISIBLE BEFORE THE CATARACT AND VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20133183 ↗MalfunctionSep 4, 2024Fitting Problem; Fitting Problem
A PHYSICIAN REPORTED THAT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY AN OPHTHALMIC LASER PROBE COULD NOT BE INSERTED INTO TROCAR. THE SURGERY WAS COMPLETED POST REPLACING THE PRODUCT WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20132265 ↗
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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