ClearCut® 8065982665Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® HP2 Slit Knife Dual Bevel 2.6mm Angled · Class 1
All models of ClearCut (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380659826658), received between Sep 21, 2021 and Jul 10, 2025 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (5 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt5
- Failure to Cut1
- Wrong Label1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Wrong Label; Wrong Label
A CUSTOMER REPORTED THAT THE LABEL ON AN OPHTHALMIC CUTTING INSTRUMENT BOX WAS INCORRECT. HOWEVER, NO PROCEDURE DETAILS OR PATIENT IMPACT HAVE BEEN REPORTED AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 22467011 ↗MalfunctionJan 1, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIVES WERE EXTRA DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE KNIFE AND HERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21050847 ↗MalfunctionAug 23, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED BY USING NEW BLADE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20050147 ↗MalfunctionJun 4, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC KNIVES WERE BLUNT. SURGERY WAS COMPLETED WITH NO REPORT OF PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 19460127 ↗MalfunctionMay 24, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED IT WAS FOUND THAT THE KNIVES WERE DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19390461 ↗MalfunctionJan 21, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC KNIFE WAS BLUNT AND WAS DIFFICULT TO ENTER THE CORNEA. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18549088 ↗MalfunctionSep 21, 2021Failure to Cut; Failure to Cut
A CUSTOMER REPORTED THAT FOUR OPHTHALMIC KNIVES WERE NOT SHARP ENOUGH AND DID NOT CUT DURING SURGERY. THERE WAS NO REPORT OF ANY PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT RECEIVED.
Patient problems: Insufficient Information
MAUDE report 12507281 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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