ClearCut®; Intrepid 8065992245Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® Slit Knife Intrepid micro-coaxial system 2.2 SB · Class 1
Quick summary
This Alcon ClearCut slit knife is a small ophthalmic blade used for eye surgery, including cataract procedures. The 72 reports mostly describe blades arriving dull or blunt and not cutting properly, with a few mentioning blades fragmenting or bending;6 reports involved injuries. No deaths were reported. There are no recalls naming this device.
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
- 67
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00380659922459), received between Mar 3, 2021 and Jan 28, 2026 — classified as 6 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (60 reports).
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
Most reported problems
Device problems
- Dull, Blunt60
- Adverse Event Without Identified Device or Use Problem5
- Material Fragmentation2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions46
- Insufficient Information16
- Toxic Anterior Segment Syndrome (TASS)3
- Uveitis3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Conjunctivitis2
- Corneal Edema2
- Inflammation2
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 28, 2026Dull, Blunt
A NURSE REPORTED THAT THREE KNIVES FROM THE SAME LOT OPHTHALMIC CUTTING KNIFES WERE FOUND TO BE DULL DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED BY CHANGING ANOTHER BLADE WITHOUT ANY PATIENT IMPACT. THIS REPORT PERTAINS TO TWO OF THE TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199097 ↗MalfunctionJan 28, 2026Dull, Blunt
A NURSE REPORTED THAT THREE KNIVES FROM THE SAME LOT OPHTHALMIC CUTTING KNIFES WERE FOUND TO BE DULL DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED BY CHANGING ANOTHER BLADE WITHOUT ANY PATIENT IMPACT. THIS REPORT PERTAINS TO ONE OF THE TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24199095 ↗MalfunctionDec 31, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION AN OPHTHALMIC CUTTING KNIFE FROM THE DIFFERENT BATCH NUMBERS WERE FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23932256 ↗MalfunctionDec 31, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION AN OPHTHALMIC CUTTING KNIFE FROM THE DIFFERENT BATCH NUMBERS WERE FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23932255 ↗MalfunctionDec 31, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION AN OPHTHALMIC CUTTING KNIFE FROM THE DIFFERENT BATCH NUMBERS WERE FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23932254 ↗MalfunctionDec 12, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT, DURING VITRECTOMY SURGERY AN OPHTHALMIC BLADE WAS FOUND STIFF AND DID NOT ABLE TO INSERT PROPERLY. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23787933 ↗MalfunctionOct 17, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC KNIFE WAS BLUNT DURING CATARACT SURGERY. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23321627 ↗MalfunctionAug 29, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT FIVE OF THE OPHTHALMIC KNIVES WERE NOT SHARP DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED WITH AN ALTERNATIVE KNIFE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920889 ↗MalfunctionAug 28, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT OPHTHALMIC KNIFE WAS BLUNT DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY REPLACING AN ALTERNATIVE KNIFE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911475 ↗MalfunctionAug 27, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THE DETAILS OF PATIENT IMPACT HAVE NOT BEEN PROVIDED. THIS COMPLAINT IS PERTAINING THE THIRTEENTH OF SIXTEEN REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 22902937 ↗MalfunctionAug 27, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THE DETAILS OF PATIENT IMPACT HAVE NOT BEEN PROVIDED. THIS COMPLAINT IS PERTAINING THE SEVENTH OF SIXTEEN REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 22901975 ↗MalfunctionAug 5, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIFE WAS CUTTING POOR. THE PROCEDURE WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713914 ↗MalfunctionJul 22, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY SIX OPHTHALMIC KNIVES FROM THE SAME LOT WERE FOUND DULL. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22565199 ↗MalfunctionJul 21, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED BY USING NEW KNIFE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22557257 ↗MalfunctionJul 14, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT A KNIFE COULD NOT CUT WHEN USING IT DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22494423 ↗MalfunctionJun 30, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT OPHTHALMIC BLADE COULD NOT CUT WHEN USED DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. PROCEDURE DETAILS WERE NOT PROVIDED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22352676 ↗MalfunctionMar 5, 2025Dull, Blunt; Dull, Blunt
THE CUSTOMER REPORTED THAT THE BLADE WAS NOT SHARP ENOUGH. THE PROCEDURE AND PATIENT IMPACT WERE NO REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21524698 ↗MalfunctionFeb 24, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC BLADE WAS NOT SHARP ENOUGH. THE REPORTER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 21445402 ↗MalfunctionJan 3, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED DURING THE SURGERY; OPHTHALMIC KNIFE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER BACKUP ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER WERE NOT AVAILABLE. THERE WAS NO PATIENT HARM. THE PROCEDURE TYPE WAS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21066202 ↗MalfunctionDec 5, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND DIFFICULT TO CUT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20852507 ↗MalfunctionDec 5, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND LESS SHARP AS EXPECTED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20851047 ↗MalfunctionNov 29, 2024Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT DURING MULTIPLE CATARACT SURGERIES, AN OPHTHALMIC CUTTING KNIVES DID NOT CUT. THE SURGERIES WERE COMPLETED ON THE SAME DAY EACH TIME. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE REVIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20809162 ↗MalfunctionNov 7, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20630821 ↗MalfunctionSep 10, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT OPHTHALMIC KNIVES WERE FOUND TO BE DULL DURING THE SURGERY. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20179324 ↗MalfunctionAug 13, 2024Dull, Blunt; Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 19970190 ↗
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.