ClearCut® 8065983065Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® HP2 Slit Knife Dual Bevel 3.0mm Angled · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00380659830655), received between Jul 28, 2021 and Jan 8, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (15 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.
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-2659-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt15
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Insufficient Information7
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. DETAILS REGARDING THE PROCEDURE AND ANY PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. THIS REPORT PERTAINS TO TWO OF TWO BATCHES REPORTED FROM THE SAME FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24002246 ↗MalfunctionJan 8, 2026Dull, Blunt
A CUSTOMER REPORTED THAT TWO OPHTHALMIC CUTTING KNIVES FROM THE SAME BATCH WERE FOUND TO BE BLUNT. DETAILS REGARDING THE PROCEDURE AND ANY PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. THIS REPORT PERTAINS TO ONE OF TWO BATCHES REPORTED FROM THE SAME FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24001675 ↗MalfunctionMar 4, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT TWO OPHTHALMIC KNIVES WITH SAME LOT WERE FOUND BLUNT BEFORE CATARACT SURGERY. SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING PRODUCT WITH A NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21513013 ↗MalfunctionJan 7, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY THE OPHTHALMIC BLADE WAS NOT SHARP ENOUGH. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE TWO OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 21089931 ↗MalfunctionJan 6, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY THE OPHTHALMIC BLADES WERE NOT SHARP ENOUGH. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE KNIFE AND THERE WAS NO PATIENT HARM. THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21077755 ↗MalfunctionOct 24, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES TIPS WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20522909 ↗MalfunctionOct 1, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE THE CATARACT SURGERY, OPHTHALMIC KNIVES WERE FOUND TO BE DULL. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT IMPACT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20342589 ↗MalfunctionSep 20, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KNIFE TIP WAS BLUNT BEFORE CATARACT SURGERY WITH INTRA OCULAR IMPLANTATION. THE SURGERY WAS COMPLETED.
Patient problems: Insufficient Information
MAUDE report 20264680 ↗MalfunctionFeb 20, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC KNIFE TIP WAS BLUNT AND DID NOT PENETRATE THE CORNEA PROPERLY. PROCEDURE WAS COMPLETED USING ANOTHER NEW BLADE. NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18737332 ↗MalfunctionFeb 20, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING IMPLANTABLE COLLAMER LENS SURGERY, THE OPHTHALMIC BLADES WERE DULL. PROCEDURE WAS COMPLETED BY USING ANOTHER NEW BLADE. NO PATIENT DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 18737114 ↗MalfunctionDec 13, 2023Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE A CATARACT SURGERY THE TIP OF OPHTHALMIC KNIVES WERE BLUNT AND DUE TO THAT, NO PROPER CORNEAL INCISION WAS DONE. THE SURGERY WAS COMPLETED BY USING ANOTHER KNIFE AND NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317162 ↗MalfunctionDec 13, 2023Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE A CATARACT SURGERY THE TIP OF OPHTHALMIC KNIVES WERE BLUNT AND DUE TO THAT, NO PROPER CORNEAL INCISION WAS DONE. THE SURGERY WAS COMPLETED BY USING ANOTHER KNIFE AND NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317160 ↗MalfunctionDec 13, 2023Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE A CATARACT SURGERY THE TIP OF OPHTHALMIC KNIVES WERE BLUNT AND DUE TO THAT, NO PROPER CORNEAL INCISION WAS DONE. THE SURGERY WAS COMPLETED BY USING ANOTHER KNIFE AND NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18317158 ↗MalfunctionMay 16, 2023Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC FRONT BLADE OF THE SLIT KNIFE WAS CHIPPED, CAUSING A PROBLEM WITH INCISION. THE PROCEDURE WAS COMPLETED AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16938792 ↗MalfunctionJul 28, 2021Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT MULTIPLE KNIVES WERE BLUNT DURING SEPARATE CATARACT SURGERIES. THERE WAS NO REPORT OF ANY PATIENT HARM. THE ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT CONFIRMED THAT AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO COMPLETE EACH SURGERY. IT WAS FURTHER CONFIRMED THAT THERE WAS NO HARM TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240844 ↗
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
- V-Lance 8065912001Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls68 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
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.