ClearCut®; Intrepid 8065982465Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® HP2 Slit Knife Intrepid micro-coaxial system 2.4 DB · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon ClearCut slit knife is a surgical blade used for eye surgery incisions. Of the 159 reports, 154 are malfunctions, and most describe dull blades that cannot make the incision, sometimes requiring a switch to another knife. The reports include no deaths and 5 injuries. There is 1 open recall, started in July 2024, over knives that were reported as not sharp enough.
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
- 153
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00380659824654), received between Mar 15, 2021 and Sep 25, 2026 — classified as 5 injuries, 148 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (129 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-2658-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt129
- Particulates8
- Failure to Cut6
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem3
- Defective Component3
- Defective Device1
- Inadequacy of Device Shape and/or Size1
Patient problems
- No Clinical Signs, Symptoms or Conditions112
- Insufficient Information30
- Foreign Body In Patient4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Toxic Anterior Segment Syndrome (TASS)3
- Uveitis3
- Vitritis3
- Wound Dehiscence2
Recent adverse event reports
The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Dull, Blunt
A healthcare professional reported that during surgery, the slit knife was not sharp enough from the beginning. Procedure details and patient harm was not reported. Additional information has been requested.
Patient problems: Insufficient Information
MAUDE report 50897580 ↗MalfunctionFeb 27, 2026Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KERATOMES HAVE BEEN DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24470666 ↗MalfunctionFeb 9, 2026Inadequacy of Device Shape and/or Size
A NURSE REPORTED THAT DURING CATARACT SURGERY TWO OPHTHALMIC CUTTING BLADES EXHIBITED THAT THE INCISION WAS LARGER THAN USUAL. THE SURGERY WAS COMPLETED ON THE SAME DAY CAUSING NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24289474 ↗MalfunctionJan 13, 2026Dull, Blunt
A NURSE REPORTED THAT, AN OPHTHALMIC KNIFE WAS FOUND BLUNT FOR MAKING INCISIONS. PROCEDURE DETAILS AND TIMING OF THE EVENT ARE UNKNOWN. IT IS ALSO UNCLEAR WHETHER THE SURGERY WAS COMPLETED. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24053915 ↗MalfunctionJan 12, 2026Dull, Blunt
A NURSE REPORTED THAT, AN OPHTHALMIC KNIFE WAS FOUND BLUNT FOR MAKING INCISIONS. PROCEDURE DETAILS AND TIMING OF THE EVENT ARE UNKNOWN. IT IS ALSO UNCLEAR WHETHER THE SURGERY WAS COMPLETED. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24037614 ↗MalfunctionJan 12, 2026Dull, Blunt
A NURSE REPORTED THAT, AN OPHTHALMIC KNIFE WAS FOUND BLUNT. PROCEDURE DETAILS AND TIMING OF THE EVENT ARE UNKNOWN. IT IS ALSO UNCLEAR WHETHER THE SURGERY WAS COMPLETED. PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24035389 ↗MalfunctionJan 9, 2026Dull, Blunt
A NURSE REPORTED OPHTHALMIC KNIFE FOUND TO BE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24021205 ↗MalfunctionJan 9, 2026Dull, Blunt
A NURSE REPORTED THAT THE OPHTHALMIC KNIFE WAS FOUND TO BE BLUNT WHILE MAKING THE INCISION. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 24021198 ↗MalfunctionJan 9, 2026Dull, Blunt
A NURSE REPORTED THAT DURING SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL. DETAILS OF PROCEDURE AND PATIENT IMPACT WAS NOT PROVIDED. ADDITIONAL DETAILS HAD BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE THREE OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 24018062 ↗MalfunctionJan 9, 2026Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND FAILURE. THE SCHEDULED SURGERY WAS CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24017969 ↗MalfunctionJan 8, 2026Dull, Blunt
A NURSE REPORTED THAT DURING SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL. DETAILS OF PROCEDURE AND PATIENT IMPACT WAS NOT PROVIDED. ADDITIONAL DETAILS HAD BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE ONE OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 24002479 ↗MalfunctionJan 7, 2026Dull, Blunt
A NURSE REPORTED THAT DURING SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL. DETAILS OF PROCEDURE AND PATIENT IMPACT WAS NOT PROVIDED. ADDITIONAL DETAILS HAD BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE TWO OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 23988718 ↗MalfunctionJan 2, 2026Dull, Blunt
A CUSTOMER REPORTED THAT TWO OPHTHALMIC BLADES FROM THE SAME BATCH WERE FOUND TO BE DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23942295 ↗MalfunctionDec 1, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY THREE OPHTHALMIC CUTTING KNIVES WERE FOUND DULL. THE SURGERY WAS COMPLETED USING THE ADDITIONAL BLADES CAUSING NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680338 ↗MalfunctionNov 25, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING IT WITH ANOTHER KNIFE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23644296 ↗MalfunctionNov 21, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC KNIFE FROM THE SAME LOT NUMBER HAD A DULL BLADE. THE DETAILS OF THE PROCEDURE AND EVENT WERE NOT PROVIDED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23617136 ↗MalfunctionSep 17, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT BEFORE SURGERY AN OPHTHALMIC KNIFE WAS NOT SHARP. THE DETAILS OF THE SURGERY WAS NOT REPORTED. NO PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23072906 ↗MalfunctionSep 16, 2025Dull, Blunt; Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT OPHTHALMIC KNIFE WAS NOT SHARP WHEN OPENING THE PACKAGE FOR INSPECTION. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23062577 ↗MalfunctionSep 15, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPTHALMIC KNIVES WERE FOUND TO BE DULL. PROCEDURE DETAILS AND PATIENT IMPACT IS UNKNOW. ADDITIONAL INFORMATION WAS REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23050583 ↗MalfunctionAug 22, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE CATARACT SURGERY OPHTHALMIC KNIFE WAS FOUND TO BE BENT. NO PATIENT HARM WAS REPORTED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22870342 ↗MalfunctionJul 28, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS DULL FROM THE BEGINNING DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22630163 ↗MalfunctionJul 21, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, THE OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED THE SAME DAY USING A DIFFERENT KNIFE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553657 ↗MalfunctionJun 26, 2025Material Twisted/Bent; Material Twisted/Bent
A CUSTOMER REPORTED THAT, BEFORE SURGERY, THE TIP OF THE OPHTHALMIC KNIFE WAS NOTICED TO BE BENT UNDER THE MICROSCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BLADE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22335760 ↗MalfunctionApr 23, 2025Failure to Cut; Failure to Cut
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRA OCULAR LENS IMPLANT (IOL) AN OPHTHALMIC KNIFE EXHIBITED POOR CUTTING. THE SURGERY WAS COMPLETED THE SAME DAY USING AN ALTERNATIVE KNIFE, AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890044 ↗MalfunctionApr 17, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC BLADE WAS FOUND TO BE DULL AND IT WAS NOT CUTTING. THE ANOTHER BLADE WAS OPENED TO COMPLETED THE PROCEDURE BY MAKING THE NECESSARY CUT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857552 ↗
Other Knife, ophthalmic devices
- ClearCut® 8065921541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls215 reports
- ClearCut®; Intrepid 8065992445Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls170 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
- 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.