ClearCut® 8065921540Recalls & reported problems
Alcon Laboratories, Inc. · ClearCut® Sideport Knife Dual Bevel 1.0mm Angled · Class 1
Quick summary
This Alcon ClearCut sideport knife, used in eye surgery, has 94 reports, 93 of them malfunctions, with 1 injury and no deaths. The reports mostly describe blades that are dull or not sharp enough to cut during surgery, and several say the surgery was finished with a replacement knife. 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
- 87
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00380659215407), received between Mar 26, 2021 and Mar 13, 2026 — classified as 1 injury, 86 malfunctions.
The most frequently reported specific device problem is “Dull, Blunt” (76 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, Blunt76
- Failure to Cut5
- Material Twisted/Bent3
- Material Fragmentation2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- Insufficient Information24
- Blurred Vision1
- Conjunctivitis1
- Corneal Edema1
- Eye Pain1
- Foreign Body In Patient1
- Inflammation1
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR IMPLANTATION, A OPHTHALMIC KNIVES FROM THE SAME LOT WERE NOT SHARP AND COULD NOT PENETRATE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING ANOTHER KNIFE. THE PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 24587862 ↗MalfunctionFeb 12, 2026Dull, Blunt
A CUSTOMER REPORTED THAT OPHTHALMIC BLADE NOTED TO BE DULL DURING SURGERY. PROCEDURE WAS COMPLETED BY USING ANOTHER BLADE. PROCEDURE DETAILS AND PATIENT HARM WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN RECEIVED INDICATING SCHEDULED PROCEDURE WAS CATARACT AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24321024 ↗MalfunctionJan 12, 2026Dull, Blunt
A NURSE REPORTED THAT AN OPHTHALMIC KNIFE WAS FOUND DULL DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH AN ALTERNATIVE KNIFE AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24034467 ↗MalfunctionNov 28, 2025Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRA OCULAR LENS IMPLANT (IOL) AN OPHTHALMIC KNIFE WAS FOUND TO BE DULL PRIOR TO USE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23670843 ↗MalfunctionOct 24, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT THE OPHTHALMIC KNIFE WAS BLUNT DURING CATARACT SURGERY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED TO DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380054 ↗MalfunctionOct 24, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY SIX OF THE OPHTHALMIC KNIVES FROM SAME LOT WERE NOT SHARP. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ALTERNATIVE KNIFE AND THERE WAS NO PATIENT HARM. PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23379214 ↗MalfunctionOct 23, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC KNIFE WAS BENT BEFORE CATARACT SURGERY. THE SURGERY WAS COMPLETED USING DIFFERENT BLADES. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365377 ↗MalfunctionOct 15, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT TWO OPHTHALMIC KNIVES FROM THE SAME BATCH WERE FOUND BENT AT THE TIP. THE TIMING OF THE EVENT IS UNKNOWN. THE PROCEDURE DETAILS AND PATIENT HARM WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 23300121 ↗MalfunctionSep 9, 2025Dull, Blunt; Dull, Blunt
A HEALTH CARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC KNIFE WAS BLUNT DURING CATARACT SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23004912 ↗MalfunctionAug 4, 2025Dull, Blunt; Dull, Blunt
A SURGICAL TECHNOLOGIST REPORTED THAT AN OPHTHALMIC BLADE WAS FOUND TO BE DULL DURING SURGERY. SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING A PRODUCT WITH NEW. NO PATIENT IMPACT WAS REPORTED. THIS COMPLAINT IS PERTAINING TO SECOND OF TWO OPHTHALMIC BLADE EVENTS REPORTED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22707038 ↗InjuryJul 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION INDICATED THAT THE MOST RECENT CHART NOTE WAS FROM A NINE-DAY POSTOPERATIVE VISIT FOLLOWING INTRAOCULAR LENS (IOL) REPOSITIONING. THE BLURRINESS HAD IMPROVED, ALTHOUGH THE VISION REMAINED SOMEWHAT BLURRY. HOWEVER, THE GENERAL POSTOPERATIVE APPEARANCE WAS GOOD, WITH NO SIGNS OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS). THE PATIENT WAS ADVISED TO RETURN FOR SERIAL REFRACTIONS AT FUTURE VISITS.
Patient problems: Blurred Vision; Conjunctivitis; Corneal Edema; Eye Pain; Inflammation; Intraocular Pressure Increased; Red Eye(s); Toxic Anterior Segment Syndrome (TASS)
MAUDE report 22459871 ↗MalfunctionMay 27, 2025Dull, Blunt; Dull, Blunt
A HEALTHCARE PROFESSIONAL REPORTED THAT APPROXIMATELY FIFTEEN KNIVES FROM THE SAME BATCH WERE FOUND TO BE BLUNT DURING CATARACT SURGERIES PERFORMED BY MULTIPLE DOCTORS. THE ISSUE WAS NOTICED WHEN MAKING THE INCISION. THE SURGERIES WERE CONTINUED USING ALTERNATIVE KNIFE, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22088063 ↗MalfunctionMay 8, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT BEFORE SURGERY THE OPHTHALMIC KNIFE WAS DAMAGED AND BENT. THE PROCEDURE AND PATIENT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21986855 ↗MalfunctionApr 23, 2025Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY, THE OPHTHALMIC KNIFE WAS NOT AS SHARP AS OTHER PRODUCTS, AND IT WAS BLUNT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THE PATIENT IMPACT HAS NOT BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 21890456 ↗MalfunctionApr 23, 2025Dull, Blunt; Dull, Blunt
AN OPHTHALMOLOGIST REPORTED THAT FIVE OPHTHALMIC KNIVES WITH SAME LOT WERE FOUND BLUNT DURING CATARACT SURGERY. SURGERY WAS COMPLETED ON THE SAME DAY BY REPLACING A PRODUCT WITH NEW ONE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890049 ↗MalfunctionMar 4, 2025Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT TWO OPHTHALMIC BLADES WITH SAME LOT WERE FOUND DULL. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 21512507 ↗MalfunctionDec 9, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC CUTTING KNIVES (TWO KNIVES) WERE FOUND BENT. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20877227 ↗MalfunctionDec 5, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT, AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE BLUNT AND NOT ABLE TO CREATE PREDICTABLE INCISION. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 20852136 ↗MalfunctionOct 29, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY WITH INTRA OCULAR LENS IMPLANTATION, AN OPHTHALMIC CUTTING KNIVE WAS FOUND TO BE DULL. THE SURGERY WAS COMPLETED AND THERE WAS NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20557141 ↗MalfunctionOct 22, 2024Dull, Blunt; Dull, Blunt
A NURSE REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC CUTTING KNIFE WAS NOT SHARP. THE PATIENT WAS NOT IMPACTED. ADDITIONAL INFORMATION REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509617 ↗MalfunctionOct 17, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT AN OPHTHALMIC CUTTING KNIFE WAS FOUND TO BE DULL. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT HARM WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20470422 ↗MalfunctionAug 23, 2024Dull, Blunt; Dull, Blunt
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY THREE OPHTHALMIC SURGICAL BLADES ARE NOT SHARP AND DIFFICULTY IN MAKING THE SIDE PORT INCISION IN THE EYE (UNKNOWN) OF THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY AFTER REPLACING WITH STANDBY BLADE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044950 ↗MalfunctionAug 13, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DURING CATARACT SURGERY AN OPHTHALMIC KNIFE WAS DULL. SURGERY WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19970772 ↗MalfunctionJul 16, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT AN OPHTHALMIC SURGICAL BLADE TIP WAS BENT OR CHIPPED DURING SURGERY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THE TYPE OF PROCEDURE AND PATIENT IMPACT WERE NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19748989 ↗MalfunctionJul 16, 2024Dull, Blunt; Dull, Blunt
A CUSTOMER REPORTED THAT DUIRNG PROCEDURE SETUP, AN OPHTHALMIC CUTTING BLADE HEAD BENT BACK IN PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER BLADE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19748670 ↗
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.