Alcon 8065751657Recalls & reported problems
Alcon Laboratories, Inc. · 23 Ga Valved Trocar Cannula Entry System, 3 ct · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon valved trocar cannula entry system is used to make small openings in the eye during vitrectomy surgery. Most of the 32 reports describe the blade arriving dull or blunt and having to be replaced mid-procedure, along with leaking fluid or blood at the entry site. One injury was reported and no deaths. Reports rose from 2 in the earlier 12 months to 17 in the most recent. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380657516575), received between Apr 13, 2021 and Sep 24, 2026 — classified as 1 injury, 29 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (19 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt19
- Fluid/Blood Leak6
- Fitting Problem3
- Defective Component1
- Difficult to Insert1
- Leak/Splash1
- Material Puncture/Hole1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Retinal Degeneration1
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Dull, Blunt
A nurse reported that before vitrectomy surgery an ophthalmic trocar blade was found blunt. The surgery was completed on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884982 ↗MalfunctionSep 24, 2026Dull, Blunt
A healthcare professional reported that before the vitrectomy surgery, ophthalmic trocar has found to be dull blade and not sharp. Surgery has been completed on the same day without any harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884055 ↗MalfunctionSep 21, 2026Dull, Blunt
A healthcare professional reported that, prior to a vitrectomy procedure, two ophthalmic trocars from the same batch had blunt blades and were not sharp. The surgery was completed on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838894 ↗MalfunctionSep 4, 2026Dull, Blunt
A healthcare professional reported that the ophthalmic system had a blunt blade prior to a vitrectomy procedure. The surgery was successfully completed on the same day, and no patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50607706 ↗MalfunctionSep 4, 2026Dull, Blunt
A nurse reported that an ophthalmic entry system was found to be blunt and not sharp before the vitrectomy surgery. The patient health impact details have not been provided. Additional information has been requested and none received at the time of this report.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50605761 ↗MalfunctionJul 20, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT THE OPHTHALMIC TWO CUTTER WAS EXTREMELY DULL DURING VITRECTOMY SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25875878 ↗MalfunctionJul 17, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25856016 ↗MalfunctionJul 17, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25854566 ↗MalfunctionJun 15, 2026Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE THE VITRECTOMY SURGERY, OPHTHALMIC TROCAR BLADE WAS FOUND TO BE DULL. PATIENT DETAILS WERE NOT REPORTED. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 25505112 ↗MalfunctionJun 10, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC TROCAR TIP WAS BROKEN. THE SURGERY WAS COMPLETED AFTER REPLACEMENT OF PRODUCT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT HEALTH IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459306 ↗MalfunctionJun 9, 2026Dull, Blunt
THE PHYSICIAN REPORTED THAT DURING VITRECTOMY SURGERY OPHTHALMIC ENTRY SYSTEM BLADE WAS VERY BLUNT TO USE. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25439412 ↗MalfunctionMay 19, 2026Dull, Blunt
A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC ENTRY SYSTEM TIP WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25217417 ↗MalfunctionMar 20, 2026Dull, Blunt
A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC ENTRY SYSTEM KNIFE WAS DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24646942 ↗MalfunctionJan 23, 2026Fluid/Blood Leak; Packaging Problem
A CUSTOMER REPORTED THAT BEFORE VITRECTOMY SURGERY ENTRY SYSTEM DOES NOT SEAL PROPERLY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NEW PRODUCT. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24173050 ↗MalfunctionJan 21, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC TROCAR BLADE HAD CRACKED. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE PRODUCT, AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24129882 ↗MalfunctionMay 6, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC ENTRY SYSTEM BLADE WAS NOT SHARP DURING VITRECTOMY SURGERY. SURGERY WAS COMPLETED AFTER REPLACING A PRODUCT WITH A NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21965930 ↗MalfunctionApr 18, 2025Difficult to Insert; Defective Component; Difficult to Insert; Defective Component
A GOVERNMENT AGENCY REPORTED THAT AN OPHTHALMIC ENTRY SYSTEM EXHIBITED WITH INABILITY TO PUNCTURE THAT WAS FOUND AT THE BEGINNING OF THE SURGERY. THIS PROLONGING THE SURGERY TIME, BUT SURGERY WAS SUCCESSFULLY COMPLETED AFTER REPLACING PRODUCT WITH NEW ONE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21863565 ↗MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
A PHYSICIAN REPORTED THAT DURING CATARACT VITRECTOMY COMBINATION PROCEDURE, SELF CLOSE VALVE COULD NOT CLOSED IN AN OPHTHALMIC ENTRY SYSTEM AND CAUSED WATER LEAKAGE. SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE ENTRY SYSTEM. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20497553 ↗InjurySep 12, 2024Fitting Problem; Fitting Problem
IN LITERATURE ARTICLE, A HEALTHCARE PROFESSIONAL REPORTED THAT TO INVESTIGATE AND COMPARE THE THREE CASES DEMONSTRATE AN UNCOMMON COMPLICATION OF RETAINED SILICONE TIP WITHIN THE VALVED CANNULA VITRECTOMY SYSTEM AND THIS COMPLICATION SHOULD BE CONSIDERED WHILE USING FLEXIBLE INSTRUMENTS IN VALVED CANNULA SYSTEMS. DURING VITRECTOMY SURGERY IN THE LEFT EYE OF THE PATIENT, THE FLEXIBLE SILICONE TIP OF SCRAPPER WAS NOTED TO BE CAUGHT IN THE SHAFT OF THE ENTRY SYSTEM. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH NEW PRODUCT AND NEW TIP WITHOUT ANY COMPLICATIONS. POST OPERATION, THE PATIENT EXPERIENCED FLATTENING OF THE FOVEA. THE CURRENT CONDITION OF THE PATIENT WAS NOT RECOVERED FROM THE REPORTED EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Retinal Degeneration
MAUDE report 20199043 ↗MalfunctionJul 15, 2024Leak/Splash; Leak/Splash
A NURSE REPORTED THAT DURING A VITRECTOMY PROCEDURE ON THE RIGHT EYE, THE OPHTHALMIC ENTRY SYSTEM WAS FOUND TO BE LEAKING. SURGERY WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19738200 ↗MalfunctionMay 28, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY PUNCTURE CANNULA CANNOT BE MOVED FLEXIBLY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. DETAILS OF PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19402595 ↗MalfunctionMay 24, 2024Material Puncture/Hole; Fitting Problem; Material Puncture/Hole; Fitting Problem
A NURSE REPORTED THAT DURING VITRECTOMY SURGERY PUNCTURED CANNULA CANNOT BE MOVED FLEXIBLY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19389335 ↗MalfunctionMay 10, 2024Fluid/Blood Leak; Fluid/Blood Leak
A PHYSICIAN REPORTED THAT DURING THE OPHTHALMIC SURGERY, THE ENTRY SYSTEM WAS FOUND TO HAVE FLUID LEAKAGE. THE PATIENT'S OUTCOME WAS UNKNOWN. THERE WAS NO HARM TO PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 19285268 ↗MalfunctionMay 16, 2023Fluid/Blood Leak; Fluid/Blood Leak
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY SURGEON NOTED THAT WATER WAS LEAKING FROM THE TROCAR. THE SURGERY WAS COMPLETED WITH NEW TROCAR. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16940745 ↗MalfunctionApr 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
A GOVERNMENT AGENCY REPORTED THAT DURING VITRECTOMY SURGERY WATER KEPT COMING OUT FROM AN OPHTHALMIC TROCAR. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16711387 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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