ClearCutRecalls & reported problems across all models
Alcon Laboratories, Inc. · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
13 open recalls name at least one ClearCut model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 531
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 13
We found 17 models of ClearCut by Alcon Laboratories, Inc. in the FDA's device registry (GUDID). Together they are named in 531 adverse event reports in the FDA's MAUDE database, received between Mar 26, 2021 and Sep 25, 2026 — classified as 18 injuries, 513 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (491 reports).
13 FDA recall records name at least one of these models by its device identifier, 13 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 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-2670-2024 · 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-2669-2024 · 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-2667-2024 · 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-2666-2024 · 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-2665-2024 · 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-2660-2024 · 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-2659-2024 · 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-2657-2024 · 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-2649-2024 · 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-2645-2024 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Z-1925-2024 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Z-1924-2024 · Root cause: Process control · Recall details · FDA record ↗
- Apr 22, 2024Open, Classified
Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.
Z-1923-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported ClearCut problems
Device problems
- Dull, Blunt491
- Material Twisted/Bent12
- Particulates11
- Failure to Cut6
- Inadequacy of Device Shape and/or Size4
- Adverse Event Without Identified Device or Use Problem3
- Defective Component2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions324
- Insufficient Information190
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available10
- Corneal Edema8
- Foreign Body In Patient6
- Eye Injury5
- Corneal Abrasion4
- Wound Dehiscence3
ClearCut models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ClearCut® 8065921541Knife, ophthalmic2 recalls215 reports
- ClearCut® 8065771541Knife, ophthalmic2 recalls38 reports
- ClearCut® 8065771540Knife, ophthalmic2 recalls30 reports
- ClearCut® 8065992745Knife, ophthalmic1 recall46 reports
- ClearCut® 8065921540Knife, ophthalmic87 reports
- ClearCut® 8065992747Knife, ophthalmic1 recall20 reports
- ClearCut® 8065983065Knife, ophthalmic1 recall15 reports
- ClearCut® 8065993047Knife, ophthalmic1 recall9 reports
- ClearCut® 8065993045Knife, ophthalmic1 recall4 reports
- ClearCut® 8065992647Knife, ophthalmic1 recall1 report
- ClearCut® 8065983265Knife, ophthalmic1 recall0 reports
- ClearCut® 8065772745Knife, ophthalmic35 reports
- ClearCut® 8065982865Knife, ophthalmic17 reports
- ClearCut® 8065982665Knife, ophthalmic7 reports
- ClearCut® 8065771501Knife, ophthalmic4 reports
- ClearCut® 8065992645Knife, ophthalmic2 reports
- ClearCut® 8065993245Knife, ophthalmic1 report
Recent ClearCut 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 health care professional reported that an ophthalmic knife was dull. The details of the procedure 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 50895638 ↗MalfunctionMar 26, 2026Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY IN THE LEFT EYE, TWO OPHTHALMIC KNIVES FROM TWO DIFFERENT BATCHES WERE FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH THE SAME KNIFE AND THERE WAS NO PATIENT HARM. THIS REPORT PERTAINING TO ONE OF THE THREE REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697541 ↗MalfunctionMar 26, 2026Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY IN THE LEFT EYE, TWO OPHTHALMIC KNIVES FROM TWO DIFFERENT BATCHES WERE FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH THE SAME KNIFE AND THERE WAS NO PATIENT HARM. THIS REPORT PERTAINING TO ONE OF THE THREE REPORTS FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24697535 ↗MalfunctionMar 25, 2026Dull, Blunt
A CUSTOMER REPORTED THAT, PRIOR TO THE CATARACT SURGERY, AN OPHTHALMIC KNIFE WAS FOUND TO BE BENT UPON OPENING. THE SURGERY WAS COMPLETED USING AN ALTERNATIVE KNIFE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688428 ↗MalfunctionMar 13, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR IMPLANTATION, A OPHTHALMIC KNIVES FROM THE SAME LOT WERE NOT SHARP AND COULD NOT PENETRATE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24587862 ↗MalfunctionMar 9, 2026Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24545955 ↗MalfunctionFeb 12, 2026Dull, Blunt
A CUSTOMER REPORTED THAT OPHTHALMIC BLADE NOTED TO BE DULL DURING SURGERY. PROCEDURE WAS COMPLETED BY USING ANOTHER BLADE. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING SCHEDULED PROCEDURE WAS CATARACT AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321024 ↗MalfunctionJan 30, 2026Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT OPHTHALMIC SCALPEL WAS BLUNT. THE DETAILS OF THE PROCEDURE AND PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 24219528 ↗MalfunctionJan 12, 2026Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC KNIFE WAS FOUND DULL DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE KNIFE AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24034467 ↗MalfunctionJan 8, 2026Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. DETAILS REGARDING THE PROCEDURE AND ANY PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. THIS REPORT PERTAINS TO TWO OF TWO BATCHES REPORTED FROM THE SAME FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24002246 ↗MalfunctionJan 8, 2026Dull, Blunt
A CUSTOMER REPORTED THAT TWO OPHTHALMIC CUTTING KNIVES FROM THE SAME BATCH WERE FOUND TO BE BLUNT. DETAILS REGARDING THE PROCEDURE AND ANY PATIENT IMPACT HAVE NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NONE HAS BEEN RECEIVED TO DATE. THIS REPORT PERTAINS TO ONE OF TWO BATCHES REPORTED FROM THE SAME FACILITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 24001675 ↗MalfunctionJan 2, 2026Dull, Blunt
A NURSE REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC CUTTING KNIFE WAS FOUND BLUNT TO PERFORM THE ACCURATE INCISION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23942357 ↗MalfunctionJan 1, 2026Device Damaged Prior to Receipt by User; Dull, Blunt
A CUSTOMER REPORTED THAT THEY HAVE RECEIVED KNIFE IN DAMAGED CONDITION UPON DELIVERY. THE PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23939513 ↗MalfunctionDec 29, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED OPHTHALMIC KNIFE WAS FOUND TO BE BLUNT DURING THE OPHTHALMIC SURGERY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 23905293 ↗MalfunctionDec 19, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC KNIFE WAS BLUNT. THE PROCEDURE AND EVENT DETAILS WERE NOT REPORTED. NO PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23849644 ↗
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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