ClearCut® 8065771541Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 00380657715411), received between Aug 18, 2021 and Jun 17, 2025 — classified as 38 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (33 reports).

2 FDA recall records name this device's identifier, 2 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.

Recalls naming this device

1. 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-2649-2024 · Root cause: Process control · FDA record ↗

2. Apr 22, 2024Open, Classified

   Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Dual Bevel Sideport and A-OK Corneal/Scleral V-Lance Ophthalmic knives.

   Z-1925-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Material Twisted/Bent; Material Twisted/Bent

  A CUSTOMER REPORTED THAT, BEFORE SURGERY, TWO OPHTHALMIC BLADES FROM THE SAME BATCH WERE FOUND TO BE TIPPED OR BENT WHEN VIEWED UNDER THE MICROSCOPE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE KNIFE, AND THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22229407 ↗
• MalfunctionJun 4, 2025Material Twisted/Bent; Material Twisted/Bent

  ADDITIONAL INFORMATION INDICATES THAT SIX OPHTHALMIC BLADES FROM THE SAME BATCH WERE AFFECTED BEFORE SURGERY WHEN VIEWED UNDER THE MICROSCOPE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE KNIFE, AND THERE WAS NO PATIENT CONTACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22139349 ↗
• MalfunctionJan 20, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WHILE PREPARING THE MAIN CUT IN THE RIGHT EYE OF THE PATIENT, INSUFFICIENT SHARPNESS OF AN OPHTHALMIC SURGICAL BLADE WAS OBSERVED AND THE PUNCTURE COULD NOT BE PERFORMED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER BLADE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190656 ↗
• MalfunctionDec 13, 2024Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING SURGERY, THE DOCTORS' FOUND THAT OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. PROCEDURE DETAILS AND PATIENTS' IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE SECOND OF TWO REPORTS RECEIVED FROM THE SAME FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 20922236 ↗
• MalfunctionDec 12, 2024Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING SURGERY, THE OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED, NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE FIRST OF TWO REPORTS RECEIVED FROM THE SAME FACILITY.

  Patient problems: Insufficient Information

  MAUDE report 20912952 ↗
• MalfunctionNov 26, 2024Dull, Blunt; Dull, Blunt

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING BLADE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20783936 ↗
• MalfunctionOct 4, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT OPHTHALMIC KNIVES WERE FOUND TO BE DULL DURING THE CATARACT SURGERY. THE DETAILS OF THE PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20369394 ↗
• MalfunctionJul 20, 2024Dull, Blunt; Dull, Blunt

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING VITRECTOMY SURGERY, AN OPHTHALMIC BLADES WERE BLUNT. SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE BLADE. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19787009 ↗
• MalfunctionJun 10, 2024Dull, Blunt; Dull, Blunt

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN OPHTHALMIC KNIFE WAS BLUNT AND CUT WITH EXCESSIVE PRESSURE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 19498229 ↗
• MalfunctionApr 30, 2024Dull, Blunt; Dull, Blunt

  A HEALTHCARE PROFESSIONAL REPORTED THAT A FEMALE PATIENT UNDERWENT CATARACT SURGERY ON HER RIGHT EYE, DURING WHICH THE OPHTHALMIC KNIFE FAILED TO MAKE AN INCISION. THE SURGERY WAS COMPLETED ON THE SAME DAY USING THE SAME KNIFE WITH INCREASED FORCE, AND THEN SWITCHED TO A NEW KNIFE. THE SURGERY PROCEEDED WITHOUT COMPLICATIONS, AND NO MEDICAL OR SURGICAL INTERVENTION WAS NECESSARY. HOWEVER, THE PATIENT'S OUTCOME WAS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19211420 ↗
• MalfunctionApr 22, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT, AN OPHTHALMIC BLADES WERE FOUND TO BE DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 19151220 ↗
• MalfunctionApr 22, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING CUTTING KNIVES ARE FOUND TO NOT SHARP. THE DETAILS OF PROCEDURE AND PATIENT DETAILS WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19151063 ↗
• MalfunctionApr 10, 2024Material Separation; Material Separation

  A NURSE REPORTED THAT DURING PHACOEMULSIFICATION AND INTRAOCULAR LENS IMPLANTATION SURGERY, AN OPHTHALMIC KNIFE TIP DETACHED WHEN OPENED FOR INCISION. THERE WAS NO PATIENT CONTACT AND THE SURGERY WAS COMPLETED WITH AN ALTERNATIVE KNIFE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19077851 ↗
• MalfunctionApr 2, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL DURING SURGERY. DETAILS OF PROCEDURE WAS NOT REPORTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT SCHEDULED PROCEDURE WAS CATARACT.

  Patient problems: Insufficient Information

  MAUDE report 19019257 ↗
• MalfunctionApr 2, 2024Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT AN OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL DURING SURGERY. DETAILS OF PROCEDURE WAS NOT REPORTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION RECEIVED INDICATED THAT SCHEDULED PROCEDURE WAS CATARACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019250 ↗
• MalfunctionMar 26, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL DURING SURGERY. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING CATARACT SURGERY THE KNIVES WERE FOUND TO BE DULL. PROCEDURE WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977816 ↗
• MalfunctionMar 26, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL DURING SURGERY. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE. ADDITIONAL INFORMATION RECEIVED REPORTING THAT DURING CATARACT SURGERY THE KNIVES WERE FOUND TO BE DULL. PROCEDURE WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18977814 ↗
• MalfunctionMar 25, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC BLADES WERE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER BLADE AND THERE WAS NO HARM TO THE PATIENT. THIS COMPLAINT IS PERTAINING THE SECOND OF ELEVEN REPORTS RECEIVED FOR THE REPORTED EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18968598 ↗
• MalfunctionMar 25, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC BLADES WERE FOUND TO BE DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER BLADE AND THERE WAS NO HARM TO THE PATIENT. THIS COMPLAINT IS PERTAINING THE SIXTH OF ELEVEN REPORTS RECEIVED FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18967695 ↗
• MalfunctionMar 22, 2024Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC BLADES WERE NOTED TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM. THIS COMPLAINT IS PERTAINING THE NINTH OF ELEVEN REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958483 ↗
• MalfunctionMar 21, 2024Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC BLADES WERE NOTED TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM. THIS COMPLAINT IS PERTAINING THE EIGHTH OF ELEVEN REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18948117 ↗
• MalfunctionMar 21, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC BLADE WAS DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER BLADE AND THERE WAS NO HARM TO THE PATIENT. THIS COMPLAINT IS PERTAINING THE THIRD OF ELEVEN REPORTS RECEIVED FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18947881 ↗
• MalfunctionMar 20, 2024Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC BLADES WERE NOTED TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM. THIS COMPLAINT IS PERTAINING THE ELEVENTH OF ELEVEN REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941267 ↗
• MalfunctionMar 20, 2024Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC BLADES WERE NOTED TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT HARM. THIS COMPLAINT IS PERTAINING THE TENTH OF ELEVEN REPORTS RECEIVED FROM THE INITIAL REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18941088 ↗
• MalfunctionMar 20, 2024Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY AN OPHTHALMIC BLADE WAS DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER BLADE AND THERE WAS NO HARM TO THE PATIENT. THIS COMPLAINT IS PERTAINING THE FIFTH OF ELEVEN REPORTS RECEIVED FOR THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940788 ↗