V-Lance 8065911901Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00380659119019), received between Feb 14, 2022 and Jul 29, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (12 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-2655-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE DID NOT CUT WHEN INSERTED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE PRODUCT WITH ANOTHER ONE AND THERE WAS NO PATIENT HARM. THIS COMPLAINT IS PERTAINING TO THREE OF THREE REPORTS RECEIVED FROM THE SAME FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641153 ↗
• MalfunctionJul 9, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, TWO OPHTHALMIC CUTTING KNIVES FROM SAME BATCH FAILED TO CUT. THE SURGERY WAS COMPLETED THE SAME DAY USING ANOTHER KNIFE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455731 ↗
• MalfunctionJul 9, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT, DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, TWO OPHTHALMIC CUTTING KNIVES FROM SAME BATCH FAILED TO CUT. THE SURGERY WAS COMPLETED THE SAME DAY USING ANOTHER KNIFE. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455728 ↗
• MalfunctionJul 1, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL AND WAS UNABLE TO CUT DURING CATARACT SURGERY. THE KNIFE WAS REPLACED WITH ANOTHER PRODUCT TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. THE INVOLVED EYE AND PATIENT IDENTIFIER WERE NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369815 ↗
• MalfunctionJun 24, 2025Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT BEFORE SURGERY AN OPHTHALMIC KNIVES FROM SAME LOT NUMBER WAS FOUND SPIKED AND COULD NOT CUT. THERE WERE SEVERAL PRODUCTS FROM SAME LOT WHICH COULD NOT CUT DESPITE REPLACEMENT. THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCTS WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22313439 ↗
• MalfunctionOct 26, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING SURGERY FOUR OPHTHALMIC SURGICAL KNIVES WERE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER KNIFE. THE TYPE OF SURGERY WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20540424 ↗
• MalfunctionMay 9, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING CUTTING KNIFE WOULD NOT CUT DURING THE CATARACT SURGERY. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 19277675 ↗
• MalfunctionApr 5, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY AN OPHTHALMIC BLADE WAS BLUNT. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19048666 ↗
• MalfunctionApr 4, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY AN OPHTHALMIC BLADE WAS BLUNT. THERE WAS NO PATIENT IMPACT. PROCEDURE COMPLETION DETAILS WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19039851 ↗
• MalfunctionMar 4, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT IT WAS FOUND THAT BLADES WERE FOUND DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18833960 ↗
• MalfunctionFeb 15, 2023Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT THE OPHTHALMIC KNIFE WAS DULL DURING SURGERY. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377716 ↗
• MalfunctionFeb 14, 2022Dull, Blunt; Material Deformation; Dull, Blunt; Material Deformation

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS FOUND CHIPPED WITH NO BLADE AND COULD NOT CUT. THE SCHEDULED PROCEDURE WAS A CATARACT SURGERY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524515 ↗