ClearCut®; Intrepid 8065772265Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00380657722655), received between Sep 6, 2023 and Sep 26, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (9 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.

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-2651-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2025Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT OPHTHALMIC KNIVES FROM FOUR DIFFERENT LOT NUMBERS WERE FOUND TO BE BLUNT DURING A CATARACT SURGERY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED ON THE SAME DAY BY USING A REPLACEMENT KNIFE, AND THERE WAS NO IMPACT TO THE PATIENT. NO FURTHER INFORMATION IS EXPECTED, AS THE CUSTOMER WAS UNWILLING TO PROVIDE ADDITIONAL DETAILS. THIS REPORT PERTAINS TO THE THIRD CASE, INVOLVING ONE UNKNOWN LOT NUMBERS. A TOTAL OF 15 BLUNT KNIVES WERE REPORTED ACROSS THREE CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23152992 ↗
• MalfunctionJul 15, 2025Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING THE CATARACT SURGERY, THREE OPHTHALMIC KNIVES WERE FOUND TO BE DULL. TWO FROM THE SAME LOT AND ONE FROM A DIFFERENT LOT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE BLADE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505675 ↗
• MalfunctionJul 15, 2025Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT DURING THE CATARACT SURGERY, THREE OPHTHALMIC KNIVES WERE FOUND TO BE DULL. TWO FROM THE SAME LOT AND ONE FROM A DIFFERENT LOT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN ALTERNATIVE BLADE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505674 ↗
• MalfunctionFeb 26, 2025Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT AN FIVE OPHTHALMIC BLADES FROM THE SAME LOT WERE FOUND TO BE DULL DURING SURGERY. THE PROCEDURE WAS COMPLETED AFTER OPENING A NEW BLADE WITHOUT ANY PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21468491 ↗
• MalfunctionFeb 20, 2025Dull, Blunt; Dull, Blunt

  A PHYSICIAN REPORTED THAT DURING A CATARACT SURGERY WITH INTRA OCULAR LENS (IOL) IMPLANT, OPHTHALMIC KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED BY BACKUP KNIFE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21421956 ↗
• 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 21190127 ↗
• MalfunctionAug 9, 2024Dull, Blunt; Dull, Blunt

  A PHARMACIST REPORTED THAT TIP OF AN OPHTHALMIC SURGICAL SCALPEL WAS CROOKED AND MAKING IT IMPOSSIBLE TO USE BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER PRODUCT. NO PATIENT IMPACT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949163 ↗
• MalfunctionOct 6, 2023Dull, Blunt; Dull, Blunt

  A NURSE REPORTED THAT AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL DURING THE CATARACT SURGERY. THE SURGERY WAS COMPLETED BY THE ALTERNATIVE KNIFE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886199 ↗
• MalfunctionSep 6, 2023Dull, Blunt; Dull, Blunt

  A CUSTOMER REPORTED THAT AN OPTHALMIC OPERATING SURGICAL KNIFES WERE DULL. PROCEDURE AND PATIENT IMPACT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION REQUESTED NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17696069 ↗