ClearCut® 8065921541Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® Sideport Knife Dual Bevel 1.2mm Angled · Class 1
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon ClearCut sideport knife is a blade used in eye surgery. Its 215 reports include 7 injuries and no deaths, and most describe the knife being dull or blunt during surgery, with patient effects often not reported. There are 2 open recalls over a rise in complaints that certain knives lacked sharpness.
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
- 215
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 215 adverse event reports that list this exact device (DI 00380659215414), received between Oct 10, 2021 and Sep 25, 2026 — classified as 7 injuries, 208 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (206 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. How this data works · Data updated Oct 13, 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-2657-2024 · Root cause: Process control · 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 · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt206
- Particulates7
- Inadequacy of Device Shape and/or Size1
- Material Frayed1
- Positioning Problem1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions104
- Insufficient Information102
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Corneal Edema4
- Foreign Body In Patient4
- Corneal Abrasion2
- Conjunctival Hemorrhage1
- Wound Dehiscence1
Recent adverse event reports
The 25 most recent of 215 reports, 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 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 ↗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 HAD POOR CUTTING KNIFE EDGES. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 23847786 ↗MalfunctionApr 17, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. DETAILS OF SURGERY WAS NOT PROVIDED. NO IMPACT ON PATIENT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 21854842 ↗MalfunctionMar 12, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THREE OPHTHALMIC KNIVES FROM THE SAME LOT WERE FOUND TO BE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21584609 ↗MalfunctionFeb 10, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A CUSTOMER REPORTED THAT THIRTEEN OPHTHALMIC KNIVES WIDTH FROM SAME LOT NUMBER WERE NARROW. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21342477 ↗MalfunctionNov 11, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC KNIFE WAS FOUND DULL. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20650731 ↗MalfunctionOct 27, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SURGICAL KNIFE EXHIBITS PROBLEMS WITH CUTTING/BLADE SHARPENING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20541312 ↗MalfunctionOct 27, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT, AN OPHTHALMIC CUTTING KNIVES WERE NOT CUTTING PROPERLY. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE. THIS IS THE FIRST OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20541304 ↗MalfunctionOct 25, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT THE OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. THE SCHEDULED SURGERY WAS A CATARACT PROCEDURE. DETAILS OF PROCEDURE AND PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20530508 ↗MalfunctionOct 10, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC KNIVES WERE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20415515 ↗MalfunctionOct 4, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT OPHTHALMIC KNIVES WERE FOUND TO BE DULL DURING THE CATARACT SURGERY. THE DETAILS OF THE PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20369409 ↗InjurySep 21, 2024Unsealed Device Packaging; Positioning Problem; Unsealed Device Packaging; Positioning Problem
A NURSE REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC BLADE WAS FOUND WITH THE PROTECTIVE FOAM COVERING THE TIP WAS NOT PROPER IN PLACE. THE BLADE SCRATCHED THE NURSE, AND THERE WAS NO ISSUE. SURGERY WAS PERFORMED WITH AN ALTERNATIVE KNIFE.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20275118 ↗MalfunctionSep 17, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC KNIVES WERE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20235972 ↗MalfunctionSep 11, 2024Material Frayed; Dull, Blunt; Material Frayed; Dull, Blunt
A PHYSICIAN REPORTED THAT OPHTHALMIC KNIVES EXHIBITED INVERTED EDGE. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. NO PATIENT WAS EXPOSED DURING SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20188350 ↗MalfunctionSep 5, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC CUTTING BLADE WAS FOUND BLUNT. THE SURGERY WAS COMPLETED USING ALTERNATE BLADES. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20143167 ↗MalfunctionAug 23, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND NOT SHARP. THE SURGERY WAS COMPLETED WITH NEW KNIFE WITH NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 20050619 ↗MalfunctionAug 21, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND NOT SHARP. ALTERNATIVE KNIVES WERE USED TO PERFORM THE INCISION WITH NO PATIENT IMPACT.
Patient problems: Insufficient Information
MAUDE report 20020561 ↗MalfunctionAug 21, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND NOT SHARP. ALTERNATIVE KNIVES WERE USED TO PERFORM THE INCISION WITH NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 20020122 ↗MalfunctionAug 21, 2024Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.THIS COMPLAINT IS PERTAINING THE SEVENTEEN OF THIRTY-TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20013678 ↗MalfunctionAug 20, 2024Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.THIS COMPLAINT IS PERTAINING THE FIFTEEN OF THIRTY-TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 20004531 ↗MalfunctionAug 20, 2024Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.THIS COMPLAINT IS PERTAINING THE TWENTY OF THIRTY-TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 20003978 ↗
Other Knife, ophthalmic devices
- 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
- 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.