ClearCut®; Intrepid 8065992445Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® Slit Knife Intrepid micro-coaxial system 2.4 SB · Class 1
All models of ClearCut; Intrepid (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon ClearCut slit knife for eye surgery has 176 adverse event reports, with no deaths and 5 injuries. The reports mostly describe blades found dull or blunt during use. Two recalls name this device, and both are open: they cover sharpness complaints for certain ClearCut and A-OK eye knives.
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
- 170
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 00380659924453), received between Mar 3, 2021 and Sep 24, 2026 — classified as 5 injuries, 165 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (162 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2662-2024 · Root cause: Process control · Recall details · FDA record ↗
- 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-2663-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt162
- Material Twisted/Bent4
- Failure to Cut2
- Adverse Event Without Identified Device or Use Problem1
- Material Fragmentation1
- Material Protrusion/Extrusion1
Patient problems
- No Clinical Signs, Symptoms or Conditions126
- Insufficient Information42
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Corneal Edema2
- Blurred Vision1
- Conjunctivitis1
- Corneal Abrasion1
- Eye Pain1
Recent adverse event reports
The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Dull, Blunt
A customer reported that an ophthalmic knife was blunt during cataract surgery. Details related to patient harm 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 50884735 ↗MalfunctionSep 24, 2026Dull, Blunt
A customer reported that on seven patients the ophthalmic knives were found to be dull. The procedure details and patient impact was not reported. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50877437 ↗MalfunctionApr 6, 2026Dull, Blunt
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE OPHTHALMIC BLADES WERE FOUND DULL DURING PROCEDURE AND THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24788472 ↗MalfunctionMar 13, 2026Dull, Blunt
THE CUSTOMER REPORTED THAT DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION, FIVE OF THE OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL FROM THE SAME BATCH. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24593606 ↗MalfunctionMar 13, 2026Dull, Blunt
A CUSTOMER REPORTED THAT THE OPHTHALMIC BLADES WERE NOT SHARP AND WAS OBSERVED OVER THE LAST SIX MONTHS. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS FILE PERTAINS TO THE TWO OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 24588764 ↗MalfunctionMar 11, 2026Dull, Blunt
THE CUSTOMER REPORTED THAT AN OPHTHALMIC BLADE WAS FOUND TO BE DULL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT ITS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24574386 ↗MalfunctionMar 9, 2026Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, TEN OPHTHALMIC BLADES FROM THE SAME BATCH WERE NOT SHARP. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546360 ↗MalfunctionFeb 13, 2026Dull, Blunt
A CUSTOMER REPORTED THAT TWENTY-FOUR OPHTHALMIC BLADES WERE FOUND TO BE DULL. THE SCHEDULED PROCEDURE WAS CATARACT SURGERY AND THE EXACT TIMING OF THE EVENT IS UNKNOWN. THE SURGERY WAS COMPLETED USING THE SAME BLADE WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24332087 ↗MalfunctionFeb 13, 2026Dull, Blunt
A CUSTOMER REPORTED THAT ONE DULL OPHTHALMIC BLADE WAS FOUND DURING CATARACT SURGERY. ANOTHER BLADE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY IMPACT ON THE PATIENT. 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 24332084 ↗MalfunctionFeb 12, 2026Dull, Blunt
A NURSE REPORTED THAT OPHTHALMIC KNIVES WERE FOUND TO BE DULL DURING A CATARACT SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24322344 ↗MalfunctionJan 12, 2026Dull, Blunt
A CUSTOMER REPORTED THAT EIGHT OPHTHALMIC CUTTING BLADES FROM SAME LOT WERE FOUND TO BE DULL. THE DETAILS OF PATIENT IMPACT AND PROCEDURE DETAILS ARE UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24032105 ↗MalfunctionDec 5, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY TWO OPHTHALMIC CUTTING KNIVES WERE FOUND BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23727413 ↗MalfunctionNov 14, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING PHACOEMULSIFICATION PROCEDURE, OPHTHALMIC KNIFE WAS FOUND TO BE DULL DURING MAIN INCISION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE KNIFE. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23554310 ↗MalfunctionNov 14, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING PHACOEMULSIFICATION PROCEDURE, OPHTHALMIC KNIFE WAS FOUND TO BE DULL DURING MAIN INCISION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE KNIFE. THIS REPORT PERTAINS TO TWO OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23554307 ↗MalfunctionNov 6, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT OPHTHALMIC BLUNT KNIVES FROM THE SAME LOT NUMBER WERE IDENTIFIED DURING SURGERY AND SUBSEQUENTLY DISCARDED BY THE CUSTOMER. DETAILS OF THE PROCEDURE AND ANY PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE. THIS REPORT PERTAINS TO OTHER KNIVES DISCARDED BY THE CUSTOMER IN CASE TWO (CASE ONE INVOLVED SIX KNIVES).
Patient problems: Insufficient Information
MAUDE report 23484238 ↗MalfunctionOct 31, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT TWO OPHTHALMIC KNIVES OF DIFFERENT LOT WERE DULL DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING A NEW BLADE ON THE SAME DAY IN EACH CATARACT SURGERY. NO PATIENT IMPACT WAS REPORTED. THIS COMPLAINT IS PERTAINING TO THE TWO OF TWO REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23436374 ↗MalfunctionOct 31, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT TWO OPHTHALMIC KNIVES OF DIFFERENT LOT WERE DULL DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING A NEW BLADE ON THE SAME DAY IN EACH CATARACT SURGERY. NO PATIENT IMPACT WAS REPORTED. THIS COMPLAINT IS PERTAINING TO THE TWO OF TWO REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23436371 ↗MalfunctionOct 28, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402053 ↗MalfunctionOct 21, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT SIX OPHTHALMIC KNIVES FROM THE SAME BATCH WERE FOUND TO BE BLUNT DURING SURGERY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS IS THE FIRST OF TWO REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23346333 ↗MalfunctionOct 18, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, FOUR OPHTHALMIC KNIVES WERE FOUND DULL. THESE KNIVES WERE NOT USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23331938 ↗MalfunctionOct 18, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, FOUR OPHTHALMIC KNIVES WERE FOUND DULL. THESE KNIVES WERE NOT USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23331937 ↗MalfunctionOct 18, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, FOUR OPHTHALMIC KNIVES WERE FOUND DULL. THESE KNIVES WERE NOT USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23331935 ↗MalfunctionSep 12, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIFE WAS FOUND BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A NEW REPLACED KNIFE WITH NO IMPACT ON PATIENT. THIS COMPLAINT IS PERTAINING THE FOUR OF FOUR REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035791 ↗MalfunctionSep 12, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIFE WAS FOUND BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A NEW REPLACED KNIFE WITH NO IMPACT ON PATIENT. THIS COMPLAINT IS PERTAINING THE TWO OF FOUR REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035750 ↗MalfunctionSep 12, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIFE WAS FOUND BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A NEW REPLACED KNIFE WITH NO IMPACT ON PATIENT. THIS COMPLAINT IS PERTAINING THE ONE OF FOUR REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23035687 ↗
Other Knife, ophthalmic devices
- ClearCut® 8065921541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls215 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
- ClearCut® 8065992745Alcon Laboratories, Inc. · Knife, ophthalmic1 recall46 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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