Alcon 8065751658Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00380657516582), received between Jun 22, 2022 and Sep 15, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (16 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 15, 2024Open, Classified

   Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Comeal/Scleral V-Lance Ophthalmic knives.

   Z-2646-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Dull, Blunt

  A health care professional reported that before vitrectomy surgery ophthalmic trocar blade was found blunt. The surgery was completed on the same day with alternative product and there was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772568 ↗
• MalfunctionSep 4, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50605022 ↗
• MalfunctionJul 10, 2026Dull, Blunt

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25777014 ↗
• MalfunctionJun 12, 2026Dull, Blunt

  A NURSE REPORTED THAT, PRIOR TO A VITRECTOMY SURGERY, THE TIP OF AN OPHTHALMIC TROCAR BLADE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485934 ↗
• MalfunctionJun 8, 2026Dull, Blunt

  A NURSE REPORTED THAT, BEFORE VITRECTOMY SURGERY BLADE OF AN OPHTHALMIC TROCAR WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY. 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 25427854 ↗
• MalfunctionMar 18, 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 24629889 ↗
• MalfunctionFeb 18, 2026Dull, Blunt

  A NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY, AN OPHTHALMIC ENTRY SYSTEM BLADE WAS FOUND TO BE NOT SHARP. 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 24374182 ↗
• MalfunctionJan 8, 2026Dull, Blunt

  THE NURSE REPORTED THAT BEFORE VITRECTOMY SURGERY OPHTHALMIC TROCAR WAS NOT SHARP. THE DETAILS OF THE PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 24001821 ↗
• MalfunctionDec 15, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED THAT DURING SURGERY LEAKAGE OCCURRED FROM THE OPHTHALMIC ENTRY SYSTEM SILICONE VALVES OF STAB KNIVES. THE SURGERY WAS COMPLETED AFTER REPLACING WITH A NEW PRODUCT CAUSING NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803652 ↗
• MalfunctionJun 30, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT A PORT DID NOT STICK AND THE TIP COULD NOT BE REMOVED DURING VITRECTOMY SURGERY AND THE NEEDLE WAS DULL AND DID NOT STICK IN THE SCLERA. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22355743 ↗
• MalfunctionMar 28, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC ENTRY SYSTEM DID NOT STICK AND CUT WELL DURING CATARACT, VITRECTOMY COMBINATION SURGERY. 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 21716522 ↗
• MalfunctionMay 3, 2024Fitting Problem; Dull, Blunt; Fitting Problem; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC TROCAR COULD NOT INSERT DURING COMBINATION OF CATARACT/VITRECTOMY SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. DETAILS OF PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19236751 ↗
• MalfunctionFeb 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC TROCAR WAS LEAKED DURING CATARACT-VITRECTOMY COMBINATIONAL SURGERY. THE SURGERY WAS COMPLETED BY REPLACING ALTERNATE TROCAR WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18728457 ↗
• MalfunctionJan 18, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED THAT DURING A CATARACT-VITRECTOMY COMBINATIONAL SURGERY AN OPHTHALMIC TROCAR LEAKED FROM THE VALVE PART. THE SURGERY WAS COMPLETED BY REPLACING TROCAR WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532406 ↗
• MalfunctionDec 28, 2023Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC TROCAR COULD NOT CUT AND PIERCE THE SURGICAL SITE DURING CATARACT/VITRECTOMY COMBINATION SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18408287 ↗
• MalfunctionDec 8, 2023Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT OPHTHALMIC TROCAR COULD NOT BE INSERTED INTO THE SCLERA DURING THE SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN. THREE USED PRODUCTS WERE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18290233 ↗
• MalfunctionJun 27, 2023Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING THE VITRECTOMY, OPHTHALMIC TROCAR WAS NOT SHARP AND COULD NOT CUT THROUGH. PROCEDURE DETAILS WAS NOT PROVIDED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210994 ↗
• MalfunctionJun 21, 2023Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING A SURGERY AN OPHTHALMIC TROCAR WAS HARD TO PRICKED IN A PATIENT'S EYE. THE CANNULA WAS ALREADY PLACED IN THE EYE HENCE THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17170404 ↗
• MalfunctionApr 14, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED THAT DURING VITRECTOMY WHILE USING AN OPHTHALMIC TROCAR, LEAKAGE WAS OBSERVED. SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743081 ↗
• MalfunctionApr 10, 2023Fitting Problem; Fitting Problem

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC TROCAR CANNULA DID NOT COME OFF DURING A VITRECTOMY SURGERY. 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 16708870 ↗
• MalfunctionMar 17, 2023Fluid/Blood Leak; Fluid/Blood Leak

  A PHYSICIAN REPORTED THE LEAKAGE FROM A TROCAR CANULA DURING MACULA HOLE SURGERY AFTER INTRODUCING THE VALVE CANNULAS TO THE PATIENT¿ EYE. THE SURGERY WAS COMPLETED. THERE WAS A PATIENT CONTACT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16565155 ↗
• MalfunctionOct 7, 2022Leak/Splash; Leak/Splash

  A NURSE REPORTED THAT DURING A VITRECTOMY SURGERY AN OPHTHALMIC TROCAR WAS LEAKING WHEN IT REMOVED FROM THE STAB KNIVES. SURGERY WAS COMPLETED BY USING AN ALTERNATE PRODUCT AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15561855 ↗
• MalfunctionJun 22, 2022Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT OPHTHALMIC TROCAR WAS BLUNT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER TROCAR. PATIENT HARM WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14770093 ↗