Alcon, EngaugeRecalls & reported problems across all models
Alcon Laboratories, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 156
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 7 models of Alcon, Engauge by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 156 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2020 and Mar 5, 2026 — classified as 4 injuries, 152 malfunctions.
The most frequently reported specific device problem is “Fitting Problem” (130 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 Alcon, Engauge problems
Device problems
- Fitting Problem130
- Defective Component15
- Difficult to Insert5
- Energy Output Problem4
- Material Deformation2
- Accessory Incompatible1
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- No Clinical Signs, Symptoms or Conditions136
- Insufficient Information16
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Retinal Tear2
- Hemorrhage/Blood Loss/Bleeding1
- No Consequences Or Impact To Patient1
Alcon, Engauge models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Alcon, Engauge 8065751114Photocoagulator and accessories74 reports
- Alcon, Engauge 8065751593Photocoagulator and accessories28 reports
- Alcon, Engauge 8065751113Photocoagulator and accessories19 reports
- Alcon, Engauge 8065751709Laser, ophthalmic14 reports
- Alcon, Engauge 8065750991Laser, ophthalmic10 reports
- Alcon, Engauge 8065750978Photocoagulator and accessories9 reports
- Alcon, Engauge 8065751592Laser, ophthalmic2 reports
Recent Alcon, Engauge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Defective Component
A NURSE REPORTED THAT DURING A COMBINED CATARACT AND VITRECTOMY SURGERY, AN OPHTHALMIC LASER PROBE BECAME BENT WHILE ATTEMPTING TO INSERT IT INTO THE TROCAR CANNULA, MAKING IT UNUSABLE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A NEW LASER PROBE, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24518728 ↗MalfunctionDec 29, 2025Defective Component; Defective Component
A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY, OPHTHALMIC LASER PROBE TIP COULD NOT BE INSERTED INTO THE TROCAR CANNULA. THE ENERGY OF LASER PROBE HASN'T BEEN TESTED BECAUSE THE LASER PROBE COULD NOT BE INSERTED, CONNECTION TO DEVICE AND TEST WERE NORMAL. AFTER REPLACING WITH A NEW LASER PROBE, THE SURGERY WAS SUCCESSFULLY COMPLETED. NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905220 ↗MalfunctionDec 2, 2025Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE WOULD NOT FIT THROUGH THE PORT. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692265 ↗MalfunctionNov 6, 2025Fitting Problem; Defective Component; Fitting Problem; Defective Component
A PHYSICIAN REPORTED THAT AN OPHTHALMIC LASER PROBE WAS RESISTANCE AND WAS DIFFICULT TO INSERT INTO THE CONSOLE DURING SETUP. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23485706 ↗MalfunctionOct 31, 2025Defective Component; Defective Component
A PHYSICIAN REPORTED THAT, PRIOR TO CATARACT SURGERY, AN OPHTHALMIC LASER PROBE GOT CAUGHT AND COULD NOT BE ATTACHED DURING TESTING. THE SURGERY WAS COMPLETED THE SAME DAY USING ANOTHER PROBE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435089 ↗MalfunctionOct 30, 2025Defective Component; Defective Component
A CUSTOMER REPORTED THAT DURING SET UP, AN OPHTHALMIC LASER PROBE WOULD NOT FIT IN THE PORT. THE SURGERY WAS COMPLETED BY USING NEW PROBE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23423768 ↗MalfunctionOct 28, 2025Defective Component; Defective Component
A CUSTOMER REPORTED THAT DURING VITREORETINAL SURGERY SHAFT OF AN OPHTHALMIC LASER PROBE HAD BULGE AND THAT WOULD NOT LET IT ENTER THROUGH THE PORT ON THE EYE. A NEW LASER PROBE WAS OPENED, AND THE PROCEDURE WAS COMPLETED WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402391 ↗MalfunctionSep 18, 2025Defective Component; Defective Component
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC PROBE DID NOT ENTER THE TROCAR. THE SURGERY COMPLETED ON THE SAME DAY WITHOUT PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082673 ↗MalfunctionAug 14, 2025Fitting Problem; Fitting Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT AND VITRECTOMY COMBINATION SURGERY, THE OPHTHALMIC LASER PROBE WAS NOT ABLE TO INSERT THROUGH THE PLUG. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USED MANI TROCAR TO INSERT THE LASER PROBE INTO EYE. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 22801568 ↗InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Firing Problem; Adverse Event Without Identified Device or Use Problem; Firing Problem
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE OPHTHALMIC LASER PROBE HAD BEEN TOO POWERFUL.
Patient problems: Retinal Tear
MAUDE report 22628656 ↗MalfunctionJun 27, 2025Fitting Problem; Fitting Problem
A NURSE REPORTED THAT DURING A PHOTOCOAGULATION SURGERY, THE TIP OF THE LASER PROBE COULD NOT BE INSERTED INTO THE PUNCTURE PORT OF THE SAME SPECIFICATION APERTURE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE PROBE, AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344035 ↗MalfunctionJun 16, 2025Fitting Problem; Fitting Problem
A CUSTOMER REPORTED THAT DURING A RETINAL DETACHMENT REPAIR PROCEDURE ON THE RIGHT EYE, TWO OPHTHALMIC LASER PROBES FROM THE SAME BATCH BECAME STUCK IN THE TROCAR CANNULA, PREVENTING SMOOTH TRANSITION THROUGH THE PORT. WHEN THE PROBE WAS PULLED BACK, THE TROCAR WAS PULLED OUT ALONG WITH IT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PROBE WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22209894 ↗MalfunctionMay 2, 2025Defective Component; Defective Component
A NURSE REPORTED THAT AN OPHTHALMIC LASER PROBE COULD NOT ENTER CANNULA DURING VITRECTOMY SURGERY. SURGERY WAS COMPLETED AFTER CHANGING PRODUCT WITH A NEW ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21950516 ↗MalfunctionApr 24, 2025Fitting Problem; Fitting Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SETTING UP FOR VITRECTOMY SURGERY AN OPHTHALMIC LASER PROBE WAS UNABLE TO ENTER TROCAR. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21897688 ↗MalfunctionApr 4, 2025Fitting Problem; Fitting Problem
A NURSE REPORTED THAT DURING VITRECTOMY, MEMBRANE PEEL, FLUID GAS EXCHANGE, SF6 GAS, MACULAR OLD REPAIR IN THE LEFT EYE OF THE PATIENT AN OPHTHALMIC LASER PROBE WOULD NOT FIT THROUGH CANNULA. THE SURGERY WAS COMPLETED IN THE SAME DAY AFTER REPLACING WITH ANOTHER PROBE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773824 ↗
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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