Alcon 8065921501Recalls & reported problems
Alcon Laboratories, Inc. · Ophthalmic Knife 15° · Class 1
Quick summary
This is an Alcon ophthalmic knife, a small blade used to make incisions during eye surgery such as cataract procedures. Most of the 54 reports describe the blade arriving dull or blunt and unable to cut, with a few mentioning bent or twisted tips, fragments, or parts breaking; one report describes material left in the patient. There were no deaths and 1 injury. 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
- 53
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 00380659215018), received between Mar 24, 2021 and Jan 22, 2026 — classified as 1 injury, 52 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (40 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
Most reported problems
Device problems
- Dull, Blunt40
- Failure to Cut6
- Material Twisted/Bent5
- Break1
- Fitting Problem1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Insufficient Information9
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Corneal Edema1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Dull, Blunt
A NURSE REPORTED THAT THE OPHTHALMIC BLADE WAS FOUND TO BE DULL AND UNABLE TO CUT DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACEMENT, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145632 ↗MalfunctionJan 22, 2026Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL AND COULD NOT CUT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACING THE KNIFE, AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24143788 ↗MalfunctionJan 22, 2026Dull, Blunt
A CUSTOMER REPORTED THAT THE OPHTHALMIC BLADE WAS FOUND TO BE DULL DURING SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AFTER REPLACEMENT, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24143314 ↗MalfunctionJan 9, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT BEFORE THE SURGERY. THE DETAILS OF THE PROCEDURE WERE NOT PROVIDED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24017543 ↗MalfunctionDec 26, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT, BEFORE VITRECTOMY SURGERY AN OPHTHALMIC BLADE WAS FOUND BLUNT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING NEW BLADE WITHOUT ANY PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895098 ↗MalfunctionNov 6, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, THE TIPS OF THE OPHTHALMIC KNIVES WERE VERY BLUNT AND COULD NOT BE USED PROPERLY TO MAKE AN INCISION. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23485449 ↗MalfunctionJul 28, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE BLUNT DURING THE INTRAOCULAR IMPLANTATION. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE PRODUCT. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22628498 ↗MalfunctionJul 15, 2025Dull, Blunt; Dull, Blunt
A PHARMACIST REPORTED THAT DURING CALIBRATION AN OPHTHALMIC KNIFE WAS FOUND THAT TIP WAS CROOKED. PROCEDURE DETAILS WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 22511784 ↗MalfunctionJul 4, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION, TWO OPHTHALMIC CUTTING KNIVES WERE FOUND DULL. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22403274 ↗MalfunctionMay 19, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT BEFORE CATARACT SURGERY OPHTHALMIC KNIFE WAS VERY BLUNT AFTER OPENED AND COULD NOT BE USED PROPERLY TO MAKE AN INCISION FOR THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22042699 ↗MalfunctionApr 22, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC CUTTING KNIVES WERE FOUND TO BE DULL WHEN CATARACT EXTRACTION WITH INTRAOCULAR LENS PLACEMENT SURGERY. THE SURGERY WAS COMPLETED WITH ALTERNATIVE PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21881225 ↗MalfunctionNov 17, 2024Dull, Blunt; Dull, Blunt
A GOVERNMENT AGENCY REPORTED THAT BEFORE SURGERY, AN OPHTHALMIC BLADE WAS FOUND TO BE CURLED. THE SURGERY WAS COMPLETED BY REPLACING NEW ONE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20702492 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY, AN OPHTHALMIC KNIFE WAS FOUND CURLED AFTER OPENING THE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20610134 ↗MalfunctionSep 6, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC CUTTING KNIVES HAD AN ISSUE. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20154749 ↗MalfunctionJun 21, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY, AN OPHTHALMIC CUTTING BLADE WAS FOUND TO BE BLUNT. THE PROCEDURE WAS COMPLETED WITH REPLACING THE PRODUCT. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19583866 ↗MalfunctionMay 31, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC KNIVES WERE BLUNT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE. THIS COMPLAINT IS PERTAINING THE ONE OF TWO REPORTS RECEIVED FROM THE INITIAL REPORTER.
Patient problems: Insufficient Information
MAUDE report 19433238 ↗MalfunctionMay 15, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY IT WAS FOUND THAT THE BLADES WERE DULL. SURGERIES WERE COMPLETED USING ALTERNATIVE BLADES. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19325945 ↗MalfunctionMay 9, 2024Failure to Cut; Failure to Cut
A HEALTHCARE PROFESSIONAL REPORTED THAT OPHTHALMIC SURGICAL KNIVES DID NOT CUT. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19276702 ↗MalfunctionMay 9, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC OPERATING KNIFE WAS USED FOR THE CATARACT SURGERY. THE KNIFE WOULD NOT CONTAIN THE CUTTING EDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER PRODUCT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19276700 ↗MalfunctionMay 8, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT OPHTHALMIC KNIVES DID NOT CUT. PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED. SURGERY HAS BEEN COMPLETED BY NEW BLADE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19267207 ↗MalfunctionApr 29, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIVES EXHIBITED INSUFFICIENT CUTTING QUALITY AND DID NOT USE THEM FOR THE SCHEDULED CATARACT SURGERY. THE SURGERY WAS COMPLETED BY REPLACING WITH AN ALTERNATE KNIFE. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19210515 ↗MalfunctionApr 5, 2024Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC KNIFE WAS FOUND TO BE BLUNT UPON OPENING. HOWEVER, PATIENT AND PROCEDURE DETAILS WERE NOT REPORTED, AND NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 19048920 ↗MalfunctionMar 28, 2024Failure to Cut; Failure to Cut
A NURSE REPORTED THAT AN OPHTHALMIC OPERATING KNIFE USED FOR THE CATARACT SURGERY AND IT WOULD NOT CUT DURING THE SURGERY. THE SURGERY WAS COMPLETED WITH THE ALTERNATIVE KNIFE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18996667 ↗MalfunctionMar 6, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING SURGERY, AN OPHTHALMIC BLADES WERE NOTED TO BE DULL. THE PATIENT EXPERIENCED CORNEAL EDEMA, DESCEMET WAS COMPLETELY MISSING AND IT WAS TREATED WITH TOPICAL ANTI INFLAMMATORY DROPS. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Corneal Edema
MAUDE report 18845691 ↗MalfunctionFeb 28, 2024Material Twisted/Bent; Material Twisted/Bent
THE PHYSICIAN REPORTED THAT TIP OF THE BLADE WAS FOUND TO BE BENT BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED WITH NO REPOTS OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18796138 ↗
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.