ClearCut® 8065992745Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® Slit Knife 2.75mm Angled · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Alcon ClearCut slit knife is a small angled blade used to make incisions during eye surgery, including cataract procedures. Most of the 50 reports describe blades arriving dull or bent, or tilting so they could not puncture the cornea, sometimes forcing the surgeon to swap in another knife mid-operation. There are 2 injuries and no deaths. One open recall, started in July 2024, covers a rise in sharpness complaints for certain ClearCut ophthalmic knives.
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
- 46
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00380659927454), received between Apr 8, 2021 and Jan 1, 2026 — classified as 2 injuries, 44 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (42 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-2666-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt42
- Inadequacy of Device Shape and/or Size3
- Defective Component1
- Device Damaged Prior to Receipt by User1
- Material Twisted/Bent1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Insufficient Information6
- Wound Dehiscence2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Conjunctival Hemorrhage1
- Eye Injury1
Recent adverse event reports
The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.
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 12, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23788960 ↗InjuryDec 3, 2025Defective Component; Dull, Blunt; Defective Component; Dull, Blunt
A PHYSICIAN REPORTED THAT, DURING SURGERIES ON DIFFERENT PATIENTS, ISSUES WERE OBSERVED WITH OPHTHALMIC BLADES, AND DESCEMET¿S DETACHMENTS AT THE MAIN INCISION SITE WERE NOTED IN MULTIPLE CASES. IT IS UNKNOWN WHETHER THE SURGERIES WERE COMPLETED SUCCESSFULLY. PROCEDURE DETAILS HAVE NOT BEEN REPORTED. THE CURRENT CONDITION OF THE PATIENTS IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.
Patient problems: Eye Injury
MAUDE report 23702986 ↗MalfunctionOct 31, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT SIX OPHTHALMIC KNIVES OF SAME LOT HAD DULL BLADES DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED BY USING A NEW BLADE ON THE SAME DAY IN EACH CATARACT PROCEDURE. THERE WAS NO PATIENT HARM REPORTED. THIS COMPLAINT IS PERTAINING TO THE ONE OF TWO REPORTS RECEIVED FROM THE SAME FACILITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23433941 ↗MalfunctionJul 24, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED BY USING NEW KNIFE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22586801 ↗MalfunctionApr 30, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT, THE OPHTHALMIC CUTTING KNIFE WAS NOT CUTTING. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21932185 ↗MalfunctionApr 17, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC BLADE WHICH WAS DULL DURING CATARACT SURGERY. SURGERY WAS COMPLETED BY REPLACING BLADE WITH A NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21857823 ↗MalfunctionApr 2, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY SIX OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL FROM THE SAME LOT. THE PROCEDURE WAS COMPLETED WITH NO IMPACT ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21750215 ↗MalfunctionJan 21, 2025Dull, Blunt; Dull, Blunt
NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC KNIFE WAS FOUND DULL AND SURGERY WAS COMPLETED WITHOUT ANY PATIENT HARM BY USING OTHER KNIFE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21194638 ↗MalfunctionDec 3, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIFE WAS BLUNT AND THE MAIN INCISION REQUIRED GREATER FORCE. SURGERY WAS COMPLETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20829025 ↗MalfunctionNov 29, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERIES, AN OPHTHALMIC KNIVES WERE BLUNT AND THE MAIN INCISION REQUIRED GREATER FORCE. SURGERIES WERE COMPETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20809139 ↗MalfunctionOct 4, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL AND TROCARS ENTRY SYSTEMS MIGHT NOT MEET SHARPNESS STANDARDS AT AN UNKNOWN TIMING. IT WAS UNKNOWN IF THE SURGERY WAS COMPLETED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20370251 ↗MalfunctionAug 30, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIFE WAS BLUNT AND THE MAIN INCISION REQUIRED GREATER FORCE. SURGERY WAS COMPLETED WITH NO PATIENT HARM. THIS COMPLAINT IS PERTAINING THE TWO OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20108492 ↗MalfunctionAug 29, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIFE WAS BLUNT AND THE MAIN INCISION REQUIRED GREATER FORCE. SURGERY WAS COMPLETED WITH NO PATIENT HARM. THIS COMPLAINT IS PERTAINING THE THREE OF THREE REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20101526 ↗MalfunctionAug 13, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC SURGICAL KNIFE WAS NOT SHARP DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER KNIFE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19970140 ↗MalfunctionAug 8, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS LARGER THAN EXPECTED AND PHACOEMULSIFICATION SLEEVE WAS LEAKING. THE PATIENT HAD A LEAKY WOUND DURING PHACOEMULSIFICATION BUT NO HARM WAS REPORTED. THE DETAILS OF THE SURGERY WAS NOT REPORTED.
Patient problems: Wound Dehiscence
MAUDE report 19938657 ↗MalfunctionAug 6, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERIES, AN OPHTHALMIC KNIVES WERE BLUNT AND THE MAIN INCISION REQUIRED GREATER FORCE. SURGERIES WERE COMPETED WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19917236 ↗MalfunctionJul 31, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, THREE OPHTHALMIC KNIVES WERE BLUNT. SURGERY WAS COMPLETED WITH AN ALTERNATIVE KNIFE. PATIENT EXPERIENCED BLEEDING. CURRENT CONDITION OF PATIENT IS UNKNOWN.
Patient problems: Conjunctival Hemorrhage
MAUDE report 19870270 ↗MalfunctionJun 11, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
ADDITIONAL INFORMATION RECEIVED INDICATES THAT, PATIENT EXPERIENCED LEAKY WOUND DURING PHACOEMULSIFICATION.
Patient problems: Insufficient Information; Wound Dehiscence
MAUDE report 19509862 ↗MalfunctionMay 30, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
A HEALTHCARE PROFESSIONAL REPORTED THAT THREE OPHTHALMIC SURGICAL BLADES SIZE WAS LARGER THAN NORMAL. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19422960 ↗MalfunctionMay 20, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIFE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING ANOTHER BLADE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19349923 ↗MalfunctionFeb 9, 2024Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY, ALL THE OPHTHALMIC CUTTERS DID NOT CUT AS FINE BEFORE. PATIENT AND PROCEDURE DETAILS WERE UNKNOWN. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 18675303 ↗MalfunctionJan 29, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY ON THE RIGHT EYE OF THE MALE PATIENT WHILE PERFORMING INCISION ALL THE OPHTHALMIC KNIVES DID NOT CUT AS FINE AS BEFORE. SURGERY WAS COMPLETED BY AN ALTERNATIVE KNIFE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18594030 ↗MalfunctionDec 22, 2023Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY, THEY FOUND THAT ONE SIDE OF THE BLADE EDGES WAS NOT SHARP AND INCISION WAS NOT MADE PROPERLY. THE SURGERY WAS COMPLETED POST EXCHANGING WITH THE NEW BLADE. THE PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18381998 ↗MalfunctionNov 15, 2023Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING A SURGERY AN OPHTHALMIC KNIFE WAS DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18142896 ↗
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.