Alcon 8065751447Recalls & reported problems
Alcon Laboratories, Inc. · 23 GA Entry System, Enhanced, 3-CT · Class 2
Quick summary
This Alcon eye-surgery trocar is used to create an entry point during vitrectomy. Reports mostly describe blades being dull or blunt before surgery, sometimes bent or broken, making tissue puncture difficult or requiring another trocar. There are 29 reports, with no deaths or injuries, and no recalls name this device. Reports rose from 3 in the previous 12 months to 19 in the most recent 12 months.
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
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380657514472), received between Mar 18, 2021 and Sep 23, 2026 — classified as 23 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
- Fitting Problem2
- Break1
- Component Missing1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Insufficient Information2
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Dull, Blunt
A nurse reported that ophthalmic trocar blade was found to be blunt and not sharp before the vitrectomy surgery. Surgery has been completed on the same day without any patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50866227 ↗MalfunctionSep 18, 2026Dull, Blunt
A nurse reported that before the vitrectomy surgery, ophthalmic blade was blunt and not sharp. Patient details were not reported. It is also unclear whether the surgery was completed. There was no further patient impact was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818236 ↗MalfunctionSep 7, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50651699 ↗MalfunctionJul 10, 2026Dull, Blunt
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25777709 ↗MalfunctionJul 10, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC TROCAR BLADE WAS FOUND TO BE BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25777537 ↗MalfunctionJul 3, 2026Component Missing; Dull, Blunt
A CUSTOMER REPORTED THAT BEFORE SURGERY AN OPHTHALMIC DEVICE MISSED PARTS AND WAS UNABLE TO PUNCTURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25704693 ↗MalfunctionJul 3, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC TROCAR BLADE WAS NOT SHARP. THERE WAS NO PATIENT HARM. 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 25704113 ↗MalfunctionJun 19, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE VITRECTOMY SURGERY AN OPHTHALMIC TROCAR BLADE WAS FOUND BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT WITHOUT A PATIENT HEALTH IMPACT. THE DETAILS OF THE PROCEDURE HAVE NOT BEEN PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25560980 ↗MalfunctionJun 11, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC ENTRY SYSTEM TROCAR WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25470133 ↗MalfunctionJun 9, 2026Dull, Blunt
A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC TROCAR BLADE WAS BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447553 ↗MalfunctionJun 9, 2026Dull, Blunt
A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY OPHTHALMIC TROCAR BLADE WAS DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25447354 ↗MalfunctionJun 9, 2026Dull, Blunt
A NURSE REPORTED THAT DURING THE VITRECTOMY SURGERY AN OPHTHALMIC TROCAR WAS NOT SHARP. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT WITHOUT THE PATIENT HEALTH IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25444205 ↗MalfunctionJan 13, 2026Dull, Blunt
A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY IN THE LEFT EYE, AN OPHTHALMIC ENTRY SYSTEM BLADE WAS FOUND TO BE DULL AND NOT SHARP. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE ENTRY SYSTEM. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051098 ↗MalfunctionJul 11, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING THE VITRECTOMY SURGERY, OPHTHALMIC TROCAR BLADE WAS TOO DULL. THE SURGERY HAS BEEN COMPLETED BY ANOTHER TROCAR. THE PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 22479250 ↗MalfunctionJul 7, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE CATARACT AND VITRECTOMY COMBINATION SURGERY, THE OPHTHALMIC TROCAR TIP DAMAGED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22412595 ↗MalfunctionJan 10, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC KNIFE WAS NOT SHARP BEFORE VITRECTOMY SURGERY. SURGERY WAS COMPLETED AFTER REPLACING A PRODUCT WITH NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21121593 ↗MalfunctionOct 2, 2024Break; Break
A NURSE REPORTED THAT BEFORE SURGERY THAT A NEWLY OPENED TROCAR WAS BROKEN. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20350002 ↗MalfunctionApr 23, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC ENTRY SYSTEM WAS USED BEFORE THE VITRO RETINAL SURGERY AND BAYONET WAS NOT SHARP. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19161738 ↗MalfunctionDec 11, 2023Fitting Problem; Fitting Problem
A NURSE REPORTED THAT AN OPHTHALMIC OPERATING NEEDLE UNABLE TO REMOVE BEFORE THE VITRECTOMY SURGERY. THE PATIENT HARM WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300107 ↗MalfunctionNov 6, 2023Dull, Blunt; Dull, Blunt
CORRECTED INFORMATION RECEIVED AND STATED THAT THE REPORTED EVENT OF THE PUNCTURE SYSTEM WILL BE LEFT IN THE FLAT PART OF THE SCLERA AS A PASSAGE FOR INTRAOCULAR INSTRUMENTS TO ENTER AND EXIT. THEREFORE, THIS EVENT NO LONGER MEETS REPORTING REQUIREMENTS, BECAUSE A SERIOUS INJURY HAS NOT OCCURRED, AND IT IS NOT LIKELY THAT A RECURRENCE WOULD RESULT IN SERIOUS INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18070929 ↗MalfunctionAug 16, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT AND OPHTHALMIC ENTRY SYSTEM CANNULA GOT DETACHED DURING THE VITRECTOMY SURGERY AND THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17555946 ↗MalfunctionAug 20, 2021Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE A VITRECTOMY SURGERY AN OPHTHALMIC TROCAR WAS FOUND TO BE BLUNT. SURGERY WAS COMPLETED BY ALTERNATE TROCAR. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12349050 ↗MalfunctionMar 18, 2021Fitting Problem; Fitting Problem
A CUSTOMER REPORTED THAT THE TROCAR CAME OUT WHEN EXCHANGING THE VITRECTOR AND LIGHT PIPES DURING VITREORETINAL PROCEDURES; IT WAS REPORTED THAT THE INSIDE OF THE TROCAR WAS GRABBING OR STICKING TO THE INSTRUMENTS BEING PASSED IN AND OUT. THE SURGEON REPOSITIONED THE TROCAR BACK IN PLACE EACH TIME. THE PROCEDURES WERE COMPLETED WITHOUT PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11516896 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.