ClearCut®; Intrepid 8065772445Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® S Intrepid Micro-coaxial system Safety Slit Knife 2.4 SB · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380657724451), received between Mar 25, 2021 and Oct 23, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (4 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.
Reports received per month
Recalls naming this device
- 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-2652-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt4
- Material Fragmentation1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
- Foreign Body In Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC CUTTING BLADE WAS FOUND DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23367611 ↗MalfunctionAug 8, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT OPHTHALMIC SURGICAL BLADES WERE NOTED TO BE DULL. PROCEDURE DETAILS AND PATIENT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22748426 ↗MalfunctionSep 17, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC SURGICAL KNIFE WAS DULL. 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 20234890 ↗MalfunctionJun 25, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC KNIVES WERE FOUND DULL. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19603784 ↗MalfunctionMar 25, 2021Material Fragmentation; Material Fragmentation
A PHYSICIAN REPORTED THAT OPHTHALMIC KNIVES HAVE REPEATEDLY LEFT RESIDUAL METAL PARTICLES IN EYE WOUND SITES DURING SEPARATE CATARACT SURGERIES. THERE WAS NO REPORT OF ANY PATIENT HARM. ADDITIONAL INFORMATION IS NOT AVAILABLE FOR THIS REPORT.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 11568292 ↗
Other Knife, ophthalmic devices
- ClearCut® 8065921541Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls215 reports
- ClearCut®; Intrepid 8065992445Alcon Laboratories, Inc. · Knife, ophthalmic2 recalls170 reports
- ClearCut®; Intrepid 8065982465Alcon Laboratories, Inc. · Knife, ophthalmic1 recall153 reports
- 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.