ClearCut®; Intrepid 8065982265Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® HP2 Slit Knife Intrepid micro-coaxial system 2.2 DB · Class 1
Quick summary
This Alcon ClearCut HP2 slit knife, a surgical blade used in eye surgery, has 114 adverse event reports on file. Most describe the knife being dull, blunt or burred before use, and some describe the tip bending or failing to cut. The reports include no deaths and 3 injuries, and the number of reports rose from 14 to 39 over the last 12 months. No recalls name 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
- 104
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00380659822650), received between Mar 14, 2021 and Mar 26, 2026 — classified as 3 injuries, 101 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (89 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, Blunt89
- Failure to Cut6
- Material Twisted/Bent4
- Particulates3
- Adverse Event Without Identified Device or Use Problem2
- Defective Component1
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- Insufficient Information26
- Inflammation2
- Toxic Anterior Segment Syndrome (TASS)2
- Vitritis2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Edema1
- Fibrosis1
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2026Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT THIRTEEN OPHTHALMIC KNIVES FROM DIFFERENT LOTS WERE BLUNT. THE SCHEDULED PROCEDURE WAS INTRAOCULAR LENS IMPLANTATION. THE PROCEDURE WAS COMPLETED THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24698073 ↗MalfunctionMar 13, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PHAKIC INTRAOCULAR LENS IMPLANTATION SURGERY AN OPHTHALMIC KNIFE DID NOT PERFORM THE CUTTING FUNCTION. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THIS REPORT PERTAINS TO TWO OF THE TWO REPORTS FROM SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 24589313 ↗MalfunctionMar 13, 2026Dull, Blunt
ADDITIONAL INFORMATION RECEIVED STATING THE PATIENT WAS SCHEDULED SURGERY FOR THE RIGHT EYE (OD) CAUSING NO IMPACT ON THE PATIENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24589032 ↗InjuryFeb 14, 2026Dull, Blunt
THE HEALTH CARE PROFESSIONAL REPORTED THAT FEMALE PATIENT DURING RIGHT EYE CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION OPHTHALMIC BLADE WAS FOUND TO BE BURRED AND ROUGHNESS. THE SURGERY WAS COMPLETED ON THE SAME DAY AND HOUR WITH DIFFICULTY USING THE PRODUCT AND PATIENT EXPERIENCED KERATOPATHY AND EDEMA MORE THAN USUAL AND CYCLITIS ON THE SECOND DAY AFTER SURGERY. PATIENT WAS PRESCRIBED WITH ANTIBIOTICS AND CURRENT PATIENT CONDITION IS RESOLVING. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE HAS BEEN RECEIVED TO DATE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema; Inflammation
MAUDE report 24340385 ↗MalfunctionJan 30, 2026Dull, Blunt
A NURSE REPORTED THAT BEFORE AN INTRAOCULAR LENS IMPLANTATION SURGERY THE TIP OF AN OPHTHALMIC CUTTING KNIFE WAS FOUND BENT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER KNIFE. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24219932 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001196 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, TWO OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001195 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001194 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001193 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001190 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, TWO OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001188 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001187 ↗MalfunctionJan 8, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRA OCULAR LENS IMPLANTATION SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THERE WAS NO PATIENT HARM. THIS REPORT PERTAINS TO ONE OF TWO REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001186 ↗MalfunctionJan 5, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO FIVE OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23956506 ↗MalfunctionJan 5, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO SEVEN OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23955330 ↗MalfunctionJan 5, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO EIGHT OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23955328 ↗MalfunctionJan 5, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO SIX OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23955275 ↗MalfunctionJan 5, 2026Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO FOUR OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23955190 ↗MalfunctionDec 19, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO TWO OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23847939 ↗MalfunctionDec 19, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO ONE OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23847789 ↗MalfunctionDec 19, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO NINE OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23847778 ↗MalfunctionDec 19, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND DULL. THE SCHEDULED SURGERY WAS INTRAOCULAR LENS IMPLANTATION SURGERY. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE. THIS REPORT PERTAINS TO THREE OF NINE REPORTS FROM THE SAME FACILITY.
Patient problems: Insufficient Information
MAUDE report 23847731 ↗MalfunctionDec 4, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANTATION, ALL OPHTHALMIC KNIVES FROM TWO LOTS WERE FOUND TO BE UNSHARP AND WERE DISCARDED. A DIFFERENT KNIFE WAS USED, AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS FOR THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716359 ↗MalfunctionNov 21, 2025Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT DURING THE SURGERY FOUR OPHTHALMIC KNIVES FROM THREE DIFFERENT BATCH WERE DEFECTIVE AND DID NOT CUT PROPERLY. THE SURGERY WAS COMPLETED AFTER REPLACING THE KNIFE WITH ANOTHER ONE ON THE SAME DAY. NO PATIENT IMPACT WAS REPORTED. THIS REPORT IS PERTAINING TO TWO OF THREE DIFFERENT BATCH WITH 1 AFFECTED KNIFE REPORTED FROM THE SAME FACILITY. THIS COMPLAINT IS PERTAINING THE ONE OF THREE REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23613854 ↗MalfunctionNov 20, 2025Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT DURING THE SURGERY TWO OPHTHALMIC KNIVES FROM SAME BATCH WERE NOT CUTTING PROPERLY. THE SURGERY WAS COMPLETED AFTER REPLACING THE KNIFE WITH ANOTHER ONE ON THE SAME DAY. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602959 ↗
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® 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.