V-Lance 8065912001Recalls & reported problems
Alcon Laboratories, Inc. · Ophthalmic Corneal/Scleral V-Lance Knife 20 Gauge [1.3mm] · Class 1
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon V-Lance ophthalmic knife is a small blade used to make incisions in the eye during cataract and other eye surgery. Most of the 70 reports describe blades arriving dull or blunt and not cutting smoothly, with a few mentioning bent tips or packaging issues; some surgeries were finished with a replacement knife. There are no deaths and 2 injuries. Two open recalls, started in April and July 2024, cite an increase in sharpness complaints tied to a process control issue.
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
- 68
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00380659120015), received between Dec 25, 2021 and Feb 27, 2026 — classified as 2 injuries, 66 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (65 reports).
2 FDA recall records name this device's identifier, 2 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.
Reports received per month
Recalls naming this device
- 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-2656-2024 · Root cause: Process control · FDA record ↗
- Apr 22, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Z-1922-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt65
- Failure to Cut2
- Device Damaged Prior to Receipt by User1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
- Insufficient Information28
- Eye Pain2
- Hematoma2
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT OPHTHALMIC CUTTING KNIFE WAS NOT STINGED SMOOTHLY IN THE DURING THE SURGERY AND AFTER REPLACING THE KNIFE, BUT IT DID NOT STINGE SMOOTHLY. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24468544 ↗MalfunctionJan 5, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC BLADE WAS NOT SHARP PRIOR TO THE VITRECTOMY PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23956238 ↗MalfunctionNov 24, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY INCISIONAL INSTRUMENT TIP WAS BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23629922 ↗MalfunctionMar 24, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING THE CATARACT SURGERY, THE OPHTHALMIC KNIVES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED BY REPLACING THE KNIFE WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21675553 ↗MalfunctionDec 10, 2024Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
A PHYSICIAN REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIFE PACKAGING WAS DIFFERENT FROM USUAL. THE PROCEDURE WAS COMPLETED WITH ALTERNATIVE PRODUCT. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20889857 ↗MalfunctionNov 6, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. DETAILS OF PROCEDURE WAS NOT REPORTED. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 20619404 ↗MalfunctionNov 6, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC CUTTING KNIVES DID NOT CUT LIKE THEY DID THE PREVIOUS TIMES. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT IMPACT. THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20619108 ↗MalfunctionNov 5, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC CUTTING KNIVES DID NOT CUT LIKE THEY DID THE PREVIOUS TIMES. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20607455 ↗MalfunctionNov 5, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE NOT CUTTING PROPERLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20606541 ↗MalfunctionOct 27, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE NOT CUTTING PROPERLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20541314 ↗MalfunctionOct 27, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT, AN OPHTHALMIC CUTTING KNIVES WERE NOT CUTTING PROPERLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS IS THE THIRD OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20541248 ↗MalfunctionOct 27, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT, AN OPHTHALMIC CUTTING KNIVES WERE NOT CUTTING PROPERLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS IS THE THIRD OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20541245 ↗MalfunctionOct 27, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT, AN OPHTHALMIC CUTTING KNIVES WERE NOT CUTTING PROPERLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS IS THE THIRD OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20541243 ↗MalfunctionOct 17, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL BEFORE CATARACT SURGERY REPORTED THAT AN OPHTHALMIC CUTTING LANCET WITH BENT TIP. THE SURGERY WAS COMPLETED WITH ANOTHER LANCET WITH NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20469078 ↗MalfunctionSep 6, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIFE LACKED SHARPNESS. SURGERY WAS COMPLETED WITH AN ALTERNATIVE KNIFE AND WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20154831 ↗MalfunctionAug 21, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT OPHTHALMIC KNIVES WERE FOUND TO BE DULL DURING CATARACT SURGERY. SURGERY HAS BEEN COMPLETED BY REPLACING THE SCALPEL WITH ANOTHER SCALPEL WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20017884 ↗MalfunctionJul 16, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND BLUNT. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19750021 ↗MalfunctionJul 11, 2024Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR IMPLANTATION, OPHTHALMIC KNIVES WERE FOUND TO BE BLUNT. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 19718376 ↗MalfunctionJul 4, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC BLADES WERE NOT SHARP DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM. DETAILS OF SURGERY WAS NOT REPORTED. ADDITIONAL DETAILS HAD BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19676074 ↗MalfunctionJul 4, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC BLADES WERE CUTTING POOR DURING SURGERY. 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 19674503 ↗MalfunctionJul 2, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT THE OPHTHALMIC KNIFES DAMAGED. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19657257 ↗MalfunctionJul 1, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT THE OPHTHALMIC BLADES WERE CUTTING POORLY DURING SURGERY. THE SURGERY AND PATIENT IMPACT DETAILS WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19643821 ↗MalfunctionJun 18, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT OPHTHALMIC KNIVES FOUND TO BE DAMAGED. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 19561433 ↗MalfunctionJun 11, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT OPHTHALMIC SLIT KNIFE WAS NOT SHARP DURING SURGERY. ANOTHER SLIT KNIFE THAT IS SINGLE PACKAGED WAS OPENED AND USED, AND THE SURGERY WAS COMPLETED. THE PROCEDURE TYPE WAS UNKNOWN. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509729 ↗MalfunctionJun 6, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION PROCEDURE, AN OPHTHALMIC KNIFE WAS FOUND BLUNT PRIOR TO PATIENT CONTACT. SURGERY WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475659 ↗
Other Knife, ophthalmic devices
- ClearCut® 8065921541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls215 reports
- ClearCut®; Intrepid 8065992445Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls170 reports
- ClearCut®; Intrepid 8065982465Alcon Laboratories, Inc. · Knife, ophthalmic1 recall153 reports
- ClearCut® 8065771541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls38 reports
- ClearCut® 8065771540Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls30 reports
- ClearCut®; Intrepid 8065772465Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls7 reports
- ClearCut®; Intrepid 8065982265Alcon Laboratories, Inc. · Knife, ophthalmic104 reports
- ClearCut® 8065992745Alcon Laboratories, Inc. · Knife, ophthalmic1 recall46 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.