Clareon™ CC60WF (UDI 00380652396806)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon™ Aspheric UV Absorbing IOL - STERILE UV-Absorbing Hydrophobic Acrylic Foldable Aspheric Posterior Chamber Intraocular Lens · Class 3 · Implant
Quick summary
This Alcon Clareon CC60WF is a foldable lens implanted in the eye during cataract surgery. The 34 reports mostly describe the lens being scratched, cracked or breaking — often parts such as the haptics (the little arms) snapping off during implantation, or the lens failing to come out of the inserter cartridge. Reports also mention blurred vision and visual disturbance. There are no deaths and 4 injuries; 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
- 36
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00380652396806), received between May 29, 2022 and Sep 21, 2026 — classified as 5 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (10 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
- Scratched Material10
- Break6
- Adverse Event Without Identified Device or Use Problem5
- Crack4
- Defective Device4
- Failure to Deliver4
- Device Difficult to Setup or Prepare2
- Device Dislodged or Dislocated2
Patient problems
- Insufficient Information22
- No Clinical Signs, Symptoms or Conditions11
- Visual Disturbances3
- Blurred Vision2
- Endophthalmitis1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Adverse Event Without Identified Device or Use Problem
A non-healthcare professional reported that, following intraocular lens implantation surgery, the patient experienced blurry vision and shadows. Hence the lens was explanted and replaced with an unspecified monofocal IOL in a secondary procedure. The clinical reason for explant was other mechanical complications of lens.Additional information has been requested but is not available at the time of this report.
Patient problems: Blurred Vision
MAUDE report 50841664 ↗MalfunctionSep 15, 2026Product Quality Problem; Scratched Material
A nonhealth care professional reported that during the intraocular lens (IOL) implantation surgery, the scratch and a bubble was noticed inside the lens. Hence the lens was taken out and replaced with a new lens.Additional information was received stating that, the forceps that come with the injector was used for the surgery. The lens was inserted and then it was cut and removed from the patient's eye and it was disposed off. The surgeon stated there was bubbles inside the lens itself and the scratch was not from the forceps or loading.
Patient problems: Insufficient Information
MAUDE report 50774498 ↗MalfunctionJul 15, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 25828208 ↗MalfunctionApr 2, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT DEPLOY FROM THE INSERTER CARTRIDGE. ANOTHER UNSPECIFIED LENS WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24766797 ↗MalfunctionDec 16, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE STATED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS LOADED INTO CARTRIDGE ON INJECTED SCRATCH WAS NOTICED AND SURGEON PROCEEDED EXPLANT LENS AND NEW LENS WAS IMPLANTED. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 23816608 ↗MalfunctionSep 16, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS MISSING A HELIX. ADDITIONAL INFORMATION RECIEVED AND STATED THAT THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23066596 ↗MalfunctionAug 12, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS FOUND TO BE SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22782787 ↗MalfunctionAug 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, A CRACK WAS NOTICED ON EDGE OF LENS NEAR HAPTIC AFTER INSERTING THE LENS INTO THE PATIENT'S EYE. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THE LENS WAS LEFT IN THE EYE.
Patient problems: Insufficient Information
MAUDE report 22749530 ↗MalfunctionJul 15, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON NOTICED THAT THE HAPTIC BREAK/ TEARING OFF. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506494 ↗MalfunctionJul 13, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BOTTOM HAPTIC BROKE OFF WHEN LENS WAS IMPLANTED. LENS WAS REMOVED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 22490811 ↗MalfunctionJul 1, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS SCRATCHED DURING SURGERY. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22372380 ↗MalfunctionMay 14, 2025Break; Device Difficult to Setup or Prepare; Failure to Deliver; Break; Device Difficult to Setup or Prepare; Failure to Deliver
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS LENS LOADING DIFFICULTY. SURGEON WAS UNSURE IF THE ISSUE WAS RELATED TO CARTRIDGE, LENS LOADING SYSTEM OR USER ERROR. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22016724 ↗MalfunctionMay 13, 2025Break; Device Difficult to Setup or Prepare; Failure to Deliver; Break; Device Difficult to Setup or Prepare; Failure to Deliver
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS LENS LOADING DIFFICULTY. SURGEON WAS UNSURE IF THE ISSUE WAS RELATED TO CARTRIDGE, LENS LOADING SYSTEM OR USER ERROR. THERE WAS NO PATIENT CONTACT
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22008676 ↗MalfunctionMay 12, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF SCRATCHED INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22004270 ↗MalfunctionFeb 21, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE SURGEON NOTICED SCRATCH AFTER THE IOL WAS IMPLANTED INTO THE EYE. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21433167 ↗MalfunctionNov 19, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20721267 ↗InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 10 MONTHS 07 DAYS FOLLOWING THE INITIAL PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 20013766 ↗InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SHIMMERING LIGHTS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL SIX MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 18873368 ↗InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) THE PATIENT EXPERIENCED DYSPTOTOPSION RIGHT EYE. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS VISUAL ACUITY BLURRY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WISHED TO CHANGE TO NEAR VISION. THE SURGEON PROGNOSIS WAS GOOD.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 18281020 ↗MalfunctionNov 14, 2023Defective Device; Defective Device
A NURSE REPORTED THAT THE SURGEON NOTICED A DEFECT IN THE LENS AFTER LENS WAS IMPLANTED. THE LENS WAS CUT OUT AND REPLACED WITH A NEW LENS DURING THE INITIAL PROCEDURE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18130509 ↗MalfunctionNov 14, 2023Defective Device; Defective Device
A NURSE REPORTED THAT THE SURGEON NOTICED A DEFECT IN THE LENS AFTER LENS WAS IMPLANTED. THE LENS WAS CUT OUT AND REPLACED WITH A NEW LENS DURING THE INITIAL PROCEDURE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18130319 ↗MalfunctionAug 11, 2023Crack; Crack
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE CRACK ON LENS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17511777 ↗MalfunctionJul 27, 2023Particulates; Particulates
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED COATING/SHEEN ON LENS. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 17406160 ↗MalfunctionJul 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
A FACILITY REPRESENTATIVE REPORTED THAT A DAY AFTER INTRAOCULAR LENS IMPLANTATION, THE LENS WAS DECENTERED. THE LENS WAS RE-CENTERED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING AT DAY 1 POST OPERATIVE, THE LENS WAS DECENTERED. IN THE SURGEON'S OPINION, DUE TO TRAILING HAPTIC INSTABILITY LEAD TO OPTIC DECENTRATION IN THE CAPSULE. ADDITIONALLY IT WAS MENTIONED THAT THE PATIENT WAS HAPPY WITH VISION AND THERE WAS NO NEED OF LENS REPOSITIONING. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THE REPORT. THIS IS 2 OF 2
Patient problems: Insufficient Information
MAUDE report 17256212 ↗InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS RULED POSSIBLE ENDOPHTHALMITIS AND TREATED WITH ANTIBIOTICS AND STEROIDS. POOR VISION PROGNOSIS WAS MENTIONED. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THE SOURCE OF EVENT WAS NOT KNOWN.
Patient problems: Endophthalmitis; Visual Impairment
MAUDE report 17104931 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.