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ClearCut®; Intrepid 8065772465Recalls & reported problems

Alcon Laboratories, Inc. · ClearCut® S Intrepid Micro-coaxial system Safety Slit Knife 2.4 DB · Class 1

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380657724659), received between Jul 31, 2023 and Jan 31, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (7 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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-2653-2024 · Root cause: Process control · FDA record ↗

  2. 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-2654-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Device problems

  • Dull, Blunt7

Patient problems

  • No Clinical Signs, Symptoms or Conditions7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 31, 2025Dull, Blunt; Dull, Blunt

    A PHARMACIST REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21282030 ↗
  • MalfunctionJan 31, 2025Dull, Blunt; Dull, Blunt

    A PHARMACIST REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21282028 ↗
  • MalfunctionOct 14, 2024Dull, Blunt; Dull, Blunt

    A PHARMACIST REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING SCALPEL WAS BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH THE REPLACED PRODUCT WITH NO IMPACT ON PATIENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20446239 ↗
  • MalfunctionAug 19, 2023Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT OPHTHALMIC BLADES WERE DULL. THERE WAS NO REPORT OF PROCEDURE AND PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17580778 ↗
  • MalfunctionAug 19, 2023Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT OPHTHALMIC BLADES WERE DULL. THERE WAS NO REPORT OF PROCEDURE AND PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17580777 ↗
  • MalfunctionJul 31, 2023Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT AN OPHTHALMIC BLADE WAS DULL.PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED NONE RECEIVED TILL DATE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17424905 ↗
  • MalfunctionJul 31, 2023Dull, Blunt; Dull, Blunt

    A CUSTOMER REPORTED THAT OPHTHALMIC BLADE WERE FOUND TO BE DULL. PROCEDURE DETAILS WERE NOT REPORTED.THERE WAS NO PATIENT HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17423348 ↗

Other Knife, ophthalmic devices

All Knife, ophthalmic devices →

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