ClearCut® 8065992747Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® Slit Knife Dual Bevel 2.75mm Angled · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380659927478), received between Apr 19, 2021 and Jan 2, 2026 — classified as 2 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (16 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-2667-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt16
- Adverse Event Without Identified Device or Use Problem2
- Material Twisted/Bent2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
- Insufficient Information5
- Eye Injury2
- Prolapse2
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗MalfunctionNov 27, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, AN OPHTHALMIC KNIFE WAS FOUND TO BE BLUNT AND COULD NOT BE USED FOR THE INCISION. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23665286 ↗MalfunctionAug 29, 2025Dull, Blunt; Dull, Blunt
THE GOVERNMENT AGENCY REPORTED THAT OPHTHALMIC BLADE WAS DULL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. NO FURTHER INFORMATION EXPECTED AS CUSTOMER WAS UNWILLING TO PROVIDE.
Patient problems: Insufficient Information
MAUDE report 22921969 ↗MalfunctionAug 8, 2025Dull, Blunt; Dull, Blunt
A SURGICAL TECHNOLOGIST REPORTED THAT OPHTHALMIC BLADES WERE FOUND TO BE DULL DURING MULTIPLE SURGERIES. SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED. THIS COMPLAINT IS PERTAINING TO FIRST OF TWO OPHTHALMIC BLADE EVENTS REPORTED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22749343 ↗MalfunctionMay 21, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE A CATARACT SURGERY AN OPHTHALMIC CUTTING KNIVES WERE FOUND BLUNT AND COULD NOT BE USED NORMALLY TO MAKE AN INCISION FOR THE PATIENT. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 22059063 ↗MalfunctionApr 24, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY TWO OPHTHALMIC KNIVES OF SAME LOT WERE VERY BLUNT UPON OPENING AND COULD NOT BE USED PROPERLY TO MAKE AN INCISION FOR THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898335 ↗MalfunctionOct 26, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE CATARACT SURGERY AN OPHTHALMIC CUTTING BLADES WERE VERY BLUNT AND COULD NOT MAKE INCISIONS. PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20540319 ↗MalfunctionJul 26, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING TWO CATARACT SURGERIES, AN OPHTHALMIC KNIVES WERE BLUNT. SURGERY WAS COMPLETED ON THE SAME WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19836823 ↗MalfunctionJan 15, 2024Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT DURING A PHACOEMULSIFICATION SURGERY AN OPHTHALMIC KNIFE HAD CURLED EDGE AND COULD NOT BE USED. SURGERY WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18511112 ↗MalfunctionDec 4, 2023Material Twisted/Bent; Material Twisted/Bent
A NURSE REPORTED THAT THE KNIFE HAS CURLED EDGE DURING CATARACT SURGERY. THE PATIENT IMPACT WAS NOT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18264060 ↗MalfunctionJul 29, 2023Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC OPERATING KNIVES WAS FOUND TO BE BLUNT DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING THE ALTERNATIVE KNIVES. THERE WAS NOT PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17421491 ↗MalfunctionJun 27, 2023Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A SURGERY AN OPHTHALMIC KNIFE WAS BENT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION RECEIVED INDICATED SURGERY WAS COMPLETED WITH AN ALTERNATE BLADE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17208603 ↗MalfunctionMar 1, 2023Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT THE SURGEON WAS HAVING A HARDER TIME MAKING THE INCISION WITH THE BLADE DURING SURGERY WITH NO REPORTED PATIENT HARM. THE PROCEDURE DETAILS WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16458930 ↗MalfunctionMar 1, 2023Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC BLADES WERE FOUND TO BE DULL DURING PROCEDURE. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT PROVIDED ADDITIONAL INFORMATION HAS BEEN REQUESTED TILL NOT RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16458879 ↗MalfunctionFeb 16, 2023Dull, Blunt; Dull, Blunt
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE SURGEON WAS HAVING A HARDER TIME MAKING THE INCISION WITH THE OPHTHALMIC KERATOMES. THE PROCEDURE DETAILS AND PATIENT IMPACT WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16384971 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT DURING CATARACT SURGERY BY USING AN OPHTHALMIC KNIFE, A PATIENT EXPERIENCED IRIS PROLAPSE AND IRIS TRAUMA. THE SURGEON USED IRIS HOOKS AND MICHOL AND COMPLETED THE SURGERY SAFELY. THE CURRENT PATIENT CONDITION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS IS THE FIRST OF TWO REPORTS FOR THE REPORTED EVENT FROM THIS FACILITY.
Patient problems: Eye Injury; Prolapse
MAUDE report 15705565 ↗InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT DURING CATARACT SURGERY BY USING AN OPHTHALMIC KNIFE, A PATIENT EXPERIENCED IRIS PROLAPSES AND IRIS TRAUMA. THE SURGEON USED IRIS HOOKS AND MICHOL AND COMPLETED THE SURGERY SAFELY. THE CURRENT PATIENT CONDITION WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS IS THE FIRST OF TWO REPORTS FOR THE REPORTED EVENT FROM THIS FACILITY.
Patient problems: Eye Injury; Prolapse
MAUDE report 15705536 ↗MalfunctionSep 22, 2021Dull, Blunt; Dull, Blunt
A HEALTH PROFESSIONAL REPORTED THAT A KNIFE WAS NOTED TO BE DULL DURING A CATARACT PROCEDURE. AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12515911 ↗MalfunctionApr 19, 2021Dull, Blunt; Dull, Blunt
A HEALTH AUTHORITY ADMINISTRATOR REPORTED THAT AN OPHTHALMIC KNIFE TIP WAS NOT SHARP DURING A CATARACT SURGERY. AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11685771 ↗
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.