ClearCut® 8065993047Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® Slit Knife Dual Bevel 3.0mm Angled · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380659930478), received between Jul 30, 2021 and Apr 29, 2025 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (7 reports).
1 FDA recall record name this device's identifier, 1 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-2670-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt7
- Material Twisted/Bent2
- Appropriate Device Problem Term/Code Not Available1
- Defective Component1
- Packaging Problem1
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Eye Injury1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE THE VITRECTOMY SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE NOT SHARP. THE SURGERY WAS COMPLETED WITH NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21925465 ↗MalfunctionOct 17, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BENT. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20470251 ↗InjuryMay 30, 2024Packaging Problem; Appropriate Device Problem Term/Code Not Available; Packaging Problem; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS CAME OUT FROM THE PACK AND IT HAS A BLOOD STAINS ON IT DUE TECHNICIAN POKING. THE DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 19422532 ↗MalfunctionOct 12, 2023Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY THE OPHTHALMIC KNIFES WERE BLUNT. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17918547 ↗MalfunctionOct 12, 2023Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY THE OPHTHALMIC KNIFES WERE BLUNT. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17918546 ↗MalfunctionSep 8, 2023Defective Component; Dull, Blunt; Defective Component; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING SURGERY AN OPHTHALMIC KNIFE EXHIBITED DULL. THE SURGERY WAS COMPLETED WITH ALTERNATE KNIFE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17711280 ↗MalfunctionAug 11, 2022Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent
A GOVERNMENT AGENCY REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC KNIFE WAS CURLED AND THE INCISION WAS NOT SHARP AND FLAT, IT IMPACTED THE CORNEAL ENDOTHELIAL INJURY AND THE POST OPERATIVE RECOVERY TIME WAS PROLONGED.
Patient problems: Eye Injury
MAUDE report 15209492 ↗MalfunctionAug 3, 2022Particulates; Particulates
PHYSICIAN REPORTED THAT DURING AN INTRA OCULAR IMPLANTATION (IOL) PROCEDURE, DEBRIS ON THE KNIVES FELL INTO THE ANTERIOR CHAMBER OF THE EYE DURING THE INCISION AND IT WAS HARD TO REMOVE. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15155971 ↗MalfunctionJul 30, 2021Dull, Blunt; Material Twisted/Bent; Dull, Blunt; Material Twisted/Bent
A HEALTH ADMINISTRATOR REPORTED THAT DURING A SURGERY AN OPHTHALMIC KNIFE BLADE WHILE MAKING INCISION WAS FOUND TO BE CURLED AND PERFORMED IRREGULAR CUTS. THE SURGERY WAS COMPLETED BY REPLACING A NEW KNIFE. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12251987 ↗
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®; Intrepid 8065982265Alcon Laboratories, Inc. · Knife, ophthalmic104 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.