ClearCut® 8065771540Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® S Safety Sideport Knife 1.0mm DB 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 small ophthalmic blade used for eye surgery, including cataract procedures. The 30 reports mostly describe the blade arriving dull or blunt, so surgeons had to push harder or swap blades mid-procedure; a few mention corneal abrasion. There are 2 injuries and no deaths. Two open recalls, started April 2024 and July 2024, say Alcon saw more sharpness complaints for these knives and traced the root cause to process control.
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
- 30
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00380657715404), received between Sep 6, 2023 and May 23, 2025 — classified as 2 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (30 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-2645-2024 · 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-1924-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt30
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Insufficient Information8
- Corneal Abrasion2
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 23, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT THE OPHTHALMIC BLADES WERE FOUND TO BE DULL FROM THE SAME LOT. 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 22077129 ↗MalfunctionMay 2, 2025Dull, Blunt; Dull, Blunt
NURSE REPORTED THAT DURING CATARACT SURGERY THEY HAD TO PUSH AN OPHTHALMIC BLADE SO HARD. PROCEDURE WAS COMPLETED BY HOLDING THE PATIENT HEAD. PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21952088 ↗MalfunctionMay 2, 2025Dull, Blunt; Dull, Blunt
NURSE REPORTED THAT DURING CATARACT SURGERY THEY HAD TO PUSH AN OPHTHALMIC BLADE SO HARD. PROCEDURE WAS COMPLETED BY HOLDING THE PATIENT HEAD. PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21952080 ↗MalfunctionNov 29, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC CUTTING BLADE BROKE OFF BEFORE USE. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20810887 ↗MalfunctionJun 19, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. 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 19567692 ↗MalfunctionMay 29, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC KNIVES WERE BLUNT. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS COMPLAINT IS PERTAINING THE TWO OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER
Patient problems: Insufficient Information
MAUDE report 19416052 ↗MalfunctionApr 24, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT, AN OPHTHALMIC BLADE WERE FOUND TO BE DULL DURING INITIAL CASE. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19170171 ↗MalfunctionApr 10, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION, AN OPHTHALMIC BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078845 ↗MalfunctionApr 10, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION, AN OPHTHALMIC BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19078839 ↗InjuryApr 6, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC BLADES WERE DULL AND ON MULTIPLE OCCASIONS PHYSICIAN HAD TO APPLY SIGNIFICANT PRESSURE TO MAKE THE INCISION AND TO GET A SHARP ONE. PHYSICIAN REPORTED PATIENTS HAD EPITHELIAL DEFECTS ON THE CORNEA AND IT IMPROVED OVER TIME.
Patient problems: Corneal Abrasion
MAUDE report 19056523 ↗InjuryApr 6, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC BLADES WERE DULL AND ON MULTIPLE OCCASIONS PHYSICIAN HAD TO APPLY SIGNIFICANT PRESSURE TO MAKE THE INCISION AND TO GET A SHARP ONE. PHYSICIAN REPORTED PATIENTS HAD EPITHELIAL DEFECTS ON THE CORNEA AND IT IMPROVED OVER TIME.
Patient problems: Corneal Abrasion
MAUDE report 19056522 ↗MalfunctionApr 1, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19012033 ↗MalfunctionMar 28, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW BLADE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994116 ↗MalfunctionMar 19, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. DETAILS OF PATIENT HARM WAS NOT PROVIDED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT NEW PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18928862 ↗MalfunctionMar 14, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18902807 ↗MalfunctionMar 8, 2024Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING PROCEDURE OPHTHALMIC BLADES WERE DULL. THE PROCEDURE COMPLETED BY REPLACING WITH ANOTHER BLADES. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18865664 ↗MalfunctionMar 8, 2024Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC BLADE WAS DULL. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER BLADE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18863923 ↗MalfunctionMar 8, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFES WERE FOUND TO DULL. THE DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18863776 ↗MalfunctionMar 8, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFES WERE FOUND TO DULL. THE DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18863774 ↗MalfunctionMar 8, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFES WERE FOUND TO DULL. THE DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18863773 ↗MalfunctionMar 8, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFES WERE FOUND TO DULL. THE DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18863770 ↗MalfunctionMar 6, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT IT WAS FOUND THAT THE BLADE WAS FOUND DULL AND COULD NOT BE USED. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION RECEIVED UPON FOLLOW UP STATING THE EVENT HAPPENED DURING THE CATARACT PROCEDURE. A SMALL WHITE BLEB APPEARED AT THE SITE IN THE PATIENT'S EYE, BUT NO INTERVENTION WAS NECESSARY. THE BLADE WAS REPLACED TO COMPLETE THE PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18847174 ↗MalfunctionMar 4, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY, AN OPHTHALMIC BLADES WERE DULL. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 18825039 ↗MalfunctionFeb 16, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT OPHTHALMIC SURGICAL BLADES WERE DULL DURING CATARACT SURGERY AND OPENED A SECOND PACK BECAUSE THESE BLADES ARE TOO DULL TO MAKE THE INCISION. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18721391 ↗MalfunctionFeb 15, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC KNIVES WERE DULL AND WOULD NOT PENETRATE CORNEA. THE SURGERY WAS COMPLETED WITH THE SAME KNIFE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18711096 ↗
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®; 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.