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ClearCut® 8065772745Recalls & reported problems

Alcon Laboratories, Inc. · ClearCut® S Safety Slit Knife 2.75mm SB Angled · Class 1

Quick summary

This Alcon ClearCut slit knife is a small angled blade used to make the opening in the eye during cataract surgery. The 35 reports almost all describe the blade arriving dull or blunt and not cutting properly, so surgeons swapped in another blade and finished the operation; one report mentions corneal edema. There are35 reports, no deaths, and 1 injury, and no recalls name this device.

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
35
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380657727452), received between Mar 6, 2024 and Sep 2, 2025 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (35 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 2 reportsApr 2024: 2 reportsMay 2024: 8 reportsJun 2024: 9 reportsJul 2024: 6 reportsAug 2024: 6 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520269
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Dull, Blunt35

Patient problems

  • No Clinical Signs, Symptoms or Conditions25
  • Insufficient Information9
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Corneal Edema1

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 2, 2025Dull, Blunt; Dull, Blunt

    A PHARMACIST REPORTED THAT DURING THE CATARACT SURGERY, OPHTHALMIC BLADE WAS FOUND TO BE POOR CUTTING. SURGERY HAS BEEN COMPLETED ON THE SAME DAY. PATIENT DETAILS WERE NOT REPORTED. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22936930 ↗
  • MalfunctionOct 27, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT IMPACT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20541247 ↗
  • MalfunctionAug 28, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT DURING SURGERY, SEVERAL PHYSICIANS FOUND BLUNT OPHTHALMIC KNIVES. SURGERY WAS COMPLETED WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20083767 ↗
  • MalfunctionAug 27, 2024Dull, Blunt; Dull, Blunt

    A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE CATARACT SURGERY, OPHTHALMIC BLADE NOT SHARP ENOUGH, NOT ABLE TO MAKE PRIMARY INCISION. SURGERY HAS BEEN COMPLETED BY USING ANOTHER BLADE WITHOUT PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20075543 ↗
  • MalfunctionAug 6, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC BLADE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED AFTER REPLACING THE BLADE WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED. THIS IS THE SECOND OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19918397 ↗
  • MalfunctionAug 6, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC BLADE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED AFTER REPLACING THE BLADE WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED. THIS IS THE SECOND OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19918345 ↗
  • MalfunctionAug 6, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT DURING THE CATARACT SURGERY THE OPHTHALMIC CUTTING BLADES WERE DULL.THE SURGERY WAS COMPLETED AFTER REPLACING THE BLADE WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED. THIS IS THE THIRD OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19918160 ↗
  • MalfunctionAug 6, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT DURING THE CATARACT SURGERY THE OPHTHALMIC CUTTING BLADES WERE DULL.THE SURGERY WAS COMPLETED AFTER REPLACING THE BLADE WITH ANOTHER ONE. NO PATIENT IMPACT WAS REPORTED. THIS IS THE THIRD OF THREE REPORTS RECEIVED FROM THE SAME INITIAL REPORTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19918006 ↗
  • 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 19787010 ↗
  • 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 19787003 ↗
  • MalfunctionJul 16, 2024Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT DUIRNG CATARACT SURGERY, AN OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT IMPACT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19749104 ↗
  • MalfunctionJul 16, 2024Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING BLADES WERE FOUND TO BE DULL. THE PROCEDURE WAS COMPLETED USING NEW BLADE. THERE WAS NO PATIENT IMPACT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19749102 ↗
  • MalfunctionJul 11, 2024Dull, Blunt; Dull, Blunt

    A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIVES WERE BLUNT. SURGERY WAS COMPLETED WITH AN ALTERNATIVE KNIFE AND WITH NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19721956 ↗
  • MalfunctionJul 8, 2024Dull, Blunt; Dull, Blunt

    A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY OPHTHALMIC KNIVES WERE FOUND BLUNT. NO PATIENT IMPACT WAS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 19691868 ↗
  • MalfunctionJun 27, 2024Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

    Patient problems: Insufficient Information

    MAUDE report 19625849 ↗
  • MalfunctionJun 27, 2024Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL. DETAILS OF PROCEDURE AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

    Patient problems: Insufficient Information

    MAUDE report 19625776 ↗
  • MalfunctionJun 20, 2024Dull, Blunt; Dull, Blunt

    A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC SURGICAL KNIFE DID NOT CUT SMOOTHLY WHILE MAKING THE INCISION IN THE LEFT EYE OF THE PATIENT 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 19573403 ↗
  • MalfunctionJun 19, 2024Dull, Blunt; Dull, Blunt

    A HEALTHCARE PROFESSIONAL REPORTED THAT KNIVES WERE BLUNT DURING CATARACT PROCEDURE. PROCEDURE WAS COMPLETED WITH ANOTHER KNIFE. THERE WAS NO PATIENT IMPACT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19567508 ↗
  • MalfunctionJun 17, 2024Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19547065 ↗
  • MalfunctionJun 17, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED WITH ALTERATIVE PRODUCT. DETAILS OF PATIENT HARM WAS NOT REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 19546021 ↗
  • MalfunctionJun 17, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED WITH ALTERATIVE PRODUCT. DETAILS OF PATIENT HARM WAS NOT REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 19546020 ↗
  • MalfunctionJun 17, 2024Dull, Blunt; Dull, Blunt

    A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT. THE SURGERY WAS COMPLETED WITH ALTERATIVE PRODUCT. DETAILS OF PATIENT HARM WAS NOT REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 19546017 ↗
  • MalfunctionJun 12, 2024Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS IMPLANT TEN OF THE OPHTHALMIC BLADES WERE FOUND TO BE DULL. THERE WAS NO HARM TO THE PATIENT WAS REPORTED. THIS COMPLAINT IS PERTAINING THE FIRST OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19517609 ↗
  • MalfunctionMay 30, 2024Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC KNIVES HAD ISSUE. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.

    Patient problems: Insufficient Information

    MAUDE report 19422712 ↗
  • MalfunctionMay 26, 2024Dull, Blunt; Dull, Blunt

    A HEALTH CARE PROFESSIONAL REPORTED OPHTHALMIC KNIVES DID NOT CUT DURING SURGERY. SURGERY WAS COMPLETED BY NEW BLADES WITHOUT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19399019 ↗

Other Knife, ophthalmic devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.