ClearCut® 8065982865Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® HP2 Slit Knife Dual Bevel 2.8mm Angled · Class 1
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00380659828652), received between Jun 24, 2021 and Jul 14, 2025 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (16 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Dull, Blunt16
- Particulates1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information8
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE A CATARACT SURGERY OPHTHALMIC KNIFE WAS FOUND NOT TO BE SHARP. PATIENT IMPACT HAS NOT BEEN REPORTED. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22500563 ↗MalfunctionJul 11, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE THE CATARACT SURGERY FIVE OPHTHALMIC CUTTING KNIVES FROM THE SAME LOT NUMBER WERE FOUND BE NOT SHARP ENOUGH. THE PATIENT HARM HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 22479843 ↗MalfunctionJan 29, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21262007 ↗MalfunctionJan 16, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC BLADE WAS DULL DURING CATARACT SURGERY. SURGERY WAS COMPLETED AFTER REPLACING BLADE WITH A NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21167699 ↗MalfunctionJan 16, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT TWO OPHTHALMIC BLADES WERE DULL DURING CATARACT SURGERY. SURGERY WAS COMPLETED AFTER CHANGING BLADES WITH A NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21166145 ↗MalfunctionJan 15, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT TWO OPHTHALMIC BLADES WERE DULL DURING CATARACT SURGERY. SURGERY WAS COMPLETED AFTER REPLACING BLADES WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21164861 ↗MalfunctionJan 15, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC BLADE WHICH WAS FOUND TO BE DULL DURING CATARACT SURGERY. SURGERY WAS COMPLETED AFTER CHANGING BLADE WITH THE NEW ONE. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 21156456 ↗MalfunctionOct 17, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL DURING USE. THE SURGERY WAS COMPLETED BY USING NEW BLADE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20471248 ↗MalfunctionOct 17, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL DURING USE. THE SURGERY WAS COMPLETED BY USING NEW BLADE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20471238 ↗MalfunctionSep 26, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE NOT SHARP. THE SURGERY WAS COMPLETED ON THE SAME DAY. NO PATIENT HARM WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20308520 ↗MalfunctionSep 10, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING BLADES WERE FOUND DULL AND COULD NOT COMPLETE THE INCISION. THE SURGERY WAS COMPLETED WITH A REPLACED BLADE WITH NO IMPACT TO THE PATIENT PROCEDURE DETAILS WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 20177849 ↗MalfunctionJul 16, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION, AN OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING ANOTHER BLADE. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19751608 ↗MalfunctionSep 21, 2023Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT THE OPHTHALMIC KNIFE WAS NOT SHARP ENOUGH DURING SURGERY. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. THE INVOLVED EYE AND THE PATIENT IDENTIFIER ARE NOT AVAILABLE. THERE'S NO PATIENT HARM. THE PROCEDURE TYPE WAS AN UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17787806 ↗MalfunctionAug 12, 2022Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT MULTIPLE OPHTHALMIC KNIVES WERE DULL DURING SEPARATE CATARACT SURGERIES. THE SURGERIES WERE COMPLETED BY USING ALTERNATE KNIVES. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217343 ↗MalfunctionAug 12, 2022Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT MULTIPLE OPHTHALMIC KNIVES WERE DULL DURING SEPARATE CATARACT SURGERIES. THE SURGERIES WERE COMPLETED BY USING ALTERNATE KNIVES. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217342 ↗MalfunctionJul 28, 2021Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT MULTIPLE KNIVES WERE BLUNT DURING SEPARATE CATARACT SURGERIES. THERE WAS NO REPORT OF ANY PATIENT HARM. THE ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT CONFIRMED THAT AN ALTERNATE KNIFE WAS OBTAINED IN ORDER TO COMPLETE EACH SURGERY. IT WAS FURTHER CONFIRMED THAT THERE WAS NO HARM TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12240852 ↗MalfunctionJun 24, 2021Particulates; Particulates
A CUSTOMER REPORTED THAT TWO OPHTHALMIC KNIVES HAD GLITTERING DEBRIS ON THE WAND EDGE WHEN THE SURGEON USED TO MAKE THE INCISION DURING A DESCEMET¿S MEMBRANE ENDOTHELIAL KERATOPLASTY (DMEK). THE SMALL METAL PARTICLES WERE VERY FINE AND WERE RETAINED IN THE PATIENT'S EYE, WHICH WERE SEEN ONLY WITH A SLIT LAMP. THE PHYSICIAN SUSPECTED THAT THE PARTICLES WERE ORIGINATED FROM THE KNIVES. THE SURGERY WAS COMPLETED BY USING A NEW KNIFE. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12059065 ↗
Other Knife, ophthalmic devices
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- ClearCut®; Intrepid 8065992445Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls170 reports
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- 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.