ClearCut®; Intrepid 8065772245Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® S Intrepid Micro-coaxial system Safety Slit Knife 2.2 SB · Class 1
1 open recall names 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
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380657722457), received between May 3, 2024 and Jan 7, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (6 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-2650-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Dull, Blunt6
- Device Contamination with Chemical or Other Material1
- Material Separation1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL. THE PATIENT IMPACT HAS NOT BEEN REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 23986842 ↗MalfunctionJun 24, 2025Dull, Blunt; Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT DURING SURGERY AN OPHTHALMIC KNIFE TIP BROKEN AND IMMEDIATELY STOPPED USING IT. THE PROCEDURE WAS COMPLETED WITH NEW ONE WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22313437 ↗MalfunctionJun 23, 2025Dull, Blunt; Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT EDGES OF AN OPHTHALMIC KNIFE WAS CURLED. THE PROCEDURE WAS COMPLETED BY USING AN ALTERNATE KNIFE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22305282 ↗MalfunctionMar 27, 2025Material Separation; Device Contamination with Chemical or Other Material; Material Separation; Device Contamination with Chemical or Other Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, AT THE MOMENT OF THE MAIN CORNEAL INCISION, THE KNIFE BROKE OFF AND REMAINED STUCK IN THE CORNEA, DETACHED FROM THE SLEEVE. THE SURGEON REMOVED THE KNIFE AND CHANGED SCALPELS. PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21712052 ↗MalfunctionSep 18, 2024Dull, Blunt; Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT MULTIPLE OPHTHALMIC SURGICAL KNIVES EDGES WERE CURLED. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH ANOTHER KNIFE. THE OTHER PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20246028 ↗MalfunctionMay 7, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC KNIVES WERE FOUND TO BE CURL BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. DETAILS OF PATIENT HARM WAS NOT REPORTED. ADDITIONAL DETAILS HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19260499 ↗MalfunctionMay 3, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC KNIFE WAS FOUND TO BE CURL DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. 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 19236931 ↗
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.