ClearCut; IntrepidRecalls & reported problems across all models
Alcon Laboratories, Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
8 open recalls name at least one ClearCut; Intrepid model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 523
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls
- 8
We found 9 models of ClearCut; Intrepid by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 523 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2021 and Sep 25, 2026 — classified as 19 injuries, 504 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (467 reports).
8 FDA recall records name at least one of these models by its device identifier, 8 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ClearCut; Intrepid recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 ↗
- 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-2658-2024 · 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-2654-2024 · 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-2653-2024 · 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-2652-2024 · 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-2651-2024 · 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-2650-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported ClearCut; Intrepid problems
Device problems
- Dull, Blunt467
- Material Twisted/Bent15
- Failure to Cut14
- Adverse Event Without Identified Device or Use Problem11
- Particulates11
- Defective Component4
- Material Fragmentation4
- Defective Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions381
- Insufficient Information123
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- Toxic Anterior Segment Syndrome (TASS)9
- Uveitis7
- Vitritis7
- Corneal Edema6
- Foreign Body In Patient6
ClearCut; Intrepid models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ClearCut®; Intrepid 8065992445Knife, ophthalmic2 recalls170 reports
- ClearCut®; Intrepid 8065982465Knife, ophthalmic1 recall153 reports
- ClearCut®; Intrepid 8065772465Knife, ophthalmic2 recalls7 reports
- ClearCut®; Intrepid 8065982265Knife, ophthalmic104 reports
- ClearCut®; Intrepid 8065992245Knife, ophthalmic67 reports
- ClearCut®; Intrepid 8065772265Knife, ophthalmic1 recall9 reports
- ClearCut®; Intrepid 8065772245Knife, ophthalmic1 recall7 reports
- ClearCut®; Intrepid 8065772445Knife, ophthalmic1 recall5 reports
- ClearCut®; Intrepid 8065981865Knife, ophthalmic1 report
Recent ClearCut; Intrepid adverse event reports
The 15 most recent reports across all models, 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 ↗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 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
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 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 ↗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 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 ↗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 ↗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 ↗
Other Alcon Laboratories, Inc. products
- Clareon1,142 models · 8,100 reports · 1 recall
- Constellation, EDGE PLUS, TOTAL PLUS, ULTRAVIT8 models · 2,968 reports · 5 recalls
- Constellation13 models · 2,176 reports · 4 recalls
- CONSTELLATION HYPERVIT TOTAL PLUS5 models · 2,098 reports · 4 recalls
- Centurion5 models · 1,967 reports
- ACRYSOF353 models · 1,890 reports
- AcrySof UltraSert102 models · 1,467 reports · 1 recall
- MONARCH III2 models · 1,380 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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