EngaugeRecalls & reported problems across all models
Alcon Laboratories, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Engauge model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 18
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 1
We found 5 models of Engauge by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 18 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2021 and Nov 18, 2025 — classified as 2 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (3 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Engauge recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 5, 2025Open, Classified
Due to incomplete seals in the pouch which provide the sterile barrier.
Z-0305-2026 · Root cause: Process control · names 3 of these models · Recall details · FDA record ↗
Most reported Engauge problems
Device problems
- Dull, Blunt3
- Adverse Event Without Identified Device or Use Problem2
- Break2
- Detachment of Device or Device Component2
- Difficult to Remove2
- Disconnection2
- Material Protrusion/Extrusion2
- Physical Resistance/Sticking2
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- Endophthalmitis2
- Blurred Vision1
- Eye Pain1
- Inflammation1
- Insufficient Information1
Engauge models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Engauge 8065751577Unit, phacofragmentation1 recall14 reports
- Engauge 8065750972Unit, phacofragmentation1 recall1 report
- Engauge 8065751441Unit, phacofragmentation1 recall0 reports
- Engauge 8065751185Unit, phacofragmentation2 reports
- Engauge 8065751486Unit, phacofragmentation1 report
Recent Engauge adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT THE TIP OF TROCAR WAS CHIPPED AT UNKNOWN TIMING. THE PROCEDURE TYPE AND COMPLETION DETAILS WERE UNKNOWN. THERE WAS NO INFORMATION ABOUT PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 23579806 ↗MalfunctionAug 8, 2025Disconnection; Disconnection
ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THE ISSUE WAS RELATED TO A MISSING TROCAR HUB OR CANNULA, AND NOT BECAUSE THE TROCAR CANNULA WAS NOT ATTACHED TO THE TROCAR BLADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22747319 ↗MalfunctionJan 7, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
A NURSE REPORTED THAT FOREIGN OBJECT PROTRUDE OR METAL PROTRUSION OCCURRED FROM THE TIP OF THE ILLUMINATOR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21089480 ↗MalfunctionJun 26, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT CUTTING OF THE TROCAR WAS POOR DURING VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19613388 ↗MalfunctionMay 10, 2024Material Protrusion/Extrusion; Material Protrusion/Extrusion
A PHYSICIAN REPORTED THAT TIP OF CHANDELIER WAS COARSE DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19287713 ↗MalfunctionOct 14, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
A CUSTOMER REPORTED THAT THE ENDOILLUMINATOR WAS STUCK IN TROCAR DURING SURGERY WITH NO PATIENT CONTACT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17936783 ↗MalfunctionJun 30, 2023Disconnection; Difficult to Remove; Disconnection; Difficult to Remove
A PHYSICIAN REPORTED THAT THE SHAFT OF TROCAR (CYLINDRICAL PART) WAS MISSING. TROCAR WAS PULLED OUT WITH THE CHANDELIER, AND THE SHAFT PART OF THE TROCAR DISAPPEARED DURING THE PARS PLANAR VITRECTOMY (PPV) SURGERY. THE SHAFT PART WAS NOT FOUND, AND SURGEON CHECKED ALL OVER THE INSIDE OF THE EYE AND ON THE CONJUNCTIVA (THERE WAS NO PARTICULAR DISCOMFORT FOUND WHEN SUTURING). THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17235577 ↗MalfunctionJun 23, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
A CUSTOMER REPORTED THAT THE ENDOILLUMINATOR WAS STUCK IN TROCAR DURING SURGERY WITH NO PATIENT CONTACT. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17191420 ↗MalfunctionApr 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN REPORTED THAT THE TROCAR CANNULA HUB WAS DETACHED FROM THE SHAFT DURING THE VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16817101 ↗MalfunctionMar 21, 2023Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT THE TROCAR DID NOT PENETRATE THE TISSUE AT ALL AND HAD A POOR CUTTING DURING SURGERY. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING IT WITH OTHER PACK. THE PROCEDURE TYPE DETAIL WAS NOT REPORTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16583426 ↗InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED POSTOPERATIVE ENDOPHTHALMITIS DURING COMBINED VITRECTOMY FOR RETINAL DETACHMENT AND CATARACT SURGERY. THE EYE WAS ALREADY FOUND CLOUDY BY THE EXAM OF THE SLIT LAMP. THE PATIENT ALSO COMPLAINED OF EYE PAIN. INTRAOCULAR WASHING WAS PERFORMED. BACKFLUSH AND OTHER PRODUCTS OF OTHER COMPANIES ARE ALSO SUSPECTED TO BE INVOLVED. OTHER EQUIPMENT IN THE FACILITY WAS ALSO BEING INVESTIGATED. RISK OF DISABILITY WAS THE SURGEON'S ASSESSMENT.
Patient problems: Blurred Vision; Endophthalmitis; Eye Pain
MAUDE report 16067389 ↗InjuryDec 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THE PATIENT DEVELOPED ENDOPHTHALMITIS TWO DAYS AFTER THE EPIRETINAL MEMBRANE (ERM) AND CATARACT COMBINED SURGERY. THE PATIENT DEVELOPED INTRAOCULAR INFLAMMATION, THEREFORE INTRAOCULAR RINSING WAS PERFORMED, AND ANTIMICROBIAL AGENTS WERE ADMINISTERED. THE PATIENT'S EYE WAS CONFIRMED TO BE IMPROVING.
Patient problems: Endophthalmitis; Inflammation
MAUDE report 16066497 ↗MalfunctionJan 5, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
A PHYSICIAN REPORTED THE SHAFT PART OF THE TROCAR CANNULA DISINTEGRATED AND WENT MISSING WHILE REMOVING THE TROCAR FROM THE EYE DURING A SURGERY. THE PRODUCT WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13167284 ↗MalfunctionOct 13, 2021Break; Break
A PHYSICIAN REPORTED A TROCAR CANNULA PORT FROM THE CHANDELIER PACK BROKE DURING USAGE IN A PROCEDURE. THE PRODUCT WAS REPLACED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12626032 ↗MalfunctionJun 7, 2021Material Separation; Material Separation
A PHYSICIAN REPORTED TROCAR SHAFT WAS FOUND ON THE FIBER OF A CHANDELIER WHILE REMOVING IT FROM A TROCAR AT THE END OF THE PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11947037 ↗
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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