Clareon™ CC60WF (UDI 00380652396844)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. Most of the 67 reports describe lens breakage and surface scratches noticed during surgery, along with haptics (the little arms) bent, torn or missing, and lenses too soft to load properly; many were removed and replaced during the same operation. There are 7 reports of injuries and no deaths. 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
- 67
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00380652396844), received between May 13, 2022 and Jul 3, 2026 — classified as 7 injuries, 60 malfunctions.
The most frequently reported specific device problem is “Break” (13 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
- Break13
- Scratched Material11
- Defective Device8
- Product Quality Problem8
- Adverse Event Without Identified Device or Use Problem6
- Material Split, Cut or Torn6
- Crack4
- Failure to Deliver2
Patient problems
- Insufficient Information38
- No Clinical Signs, Symptoms or Conditions23
- Halo3
- Blurred Vision2
- Visual Disturbances2
- Visual Impairment2
- Capsular Bag Tear1
- Eye Injury1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 3, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BENT OR COMING OUT STRAIGHT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25704834 ↗MalfunctionJun 10, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, WHILE THE LENS WAS BEING LOADED, IT WAS OBSERVED TO BE TOO SOFT AND SUCTIONED ITSELF TO ANTERIOR PART OF THE CARTRIDGE. THE SURGERY WAS COMPLETED ON THE SAME DAY USING A NEW LENS. THERE WAS NO PATIENT CONTACT WITH THE COMPLAINT PRODUCT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25458316 ↗MalfunctionJun 5, 2026Product Quality Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IOL WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25407633 ↗MalfunctionJun 4, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS NOTICED ON LENS AFTER PLACED IN THE EYE. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING 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 25394106 ↗MalfunctionMay 11, 2026Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE WHEN THE IOL WAS BEING LOADED, NOTICED A MISSING PART OF THE LENS. LENS DID NOT MAKE IT TO CARTRIDGE. ONCE THE LENS WAS OPENED ON THE SURGICAL FIELD, THE DEFECT WAS FOUND ON EXAMINATION OF THE LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145421 ↗MalfunctionMay 11, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON LENS AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136125 ↗MalfunctionApr 24, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS FOUND TO BE BROKEN. THE LENS WAS IMPLANTED AND THEN IMMEDIATELY REMOVED, AND THE INITIAL PROCEDURE WAS COMPLETED ON SAME DAY AND REPLACED WITH COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 24979354 ↗MalfunctionApr 11, 2026Scratched Material
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, SCRATCH WAS OBSERVED ON THE OPTIC CENTRALLY. HENCE THE LENS WAS CUT AND REMOVED AND REPLACED WITH ANOTHER LENS WITHOUT ANY INCIDENT DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24851432 ↗MalfunctionApr 8, 2026Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24815719 ↗MalfunctionMar 18, 2026Break
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED LENS HAD A TORN HAPTIC ON INJECTION. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24626320 ↗MalfunctionMar 7, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAPTIC WAS MISSING DURING LOADING. THE SURGERY WAS COMPLETED ON THE SAME DAY AS PLANNED WITH THE NEW LENS OF THE SAME DIOPTER WITHOUT ANY HARM TO THE PATIENT HARM. LENS WAS DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540672 ↗MalfunctionFeb 26, 2026Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, BULB WENT OUT IN OPERATION ROOM. ONCE BULB WAS REPLACED, LENS SAT FOR TOO AND COULD NOT UNFOLD IN THE EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24455605 ↗MalfunctionFeb 9, 2026Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE HAPTIC CAME OFF. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24292345 ↗MalfunctionJan 2, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23942118 ↗MalfunctionDec 25, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE HAPTIC WAS BROKEN OR TORN. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE LENS HAS BEEN CUT OUT. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23891649 ↗MalfunctionNov 12, 2025Dent in Material; Dent in Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS STREAKS ON LENS. ADDITIONAL INFORMATION RECEIVED STATING THAT, THE DOCTOR OBSERVED THE LENS UNDER THE MICROSCOPE AND SAW NO ISSUES. THE LENS WAS LOADED INTO A CARTRIDGE BY THE SCRUB TECHNICIAN. THE DOCTOR PLACED THE LENS INTO THE EYE AND IMMEDIATELY SAW A SCRATCH ON THE LENS IN THE FIELD OF VISION. THE DOCTOR REPORTED NO ISSUES WITH FIELD OF VISION AFTER HIS POST-OPERATIVE VISIT. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23534828 ↗MalfunctionAug 28, 2025Scratched Material; Scratched Material
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, A SCRATCH ON THE LENS WAS NOTICED AFTER INSERTION. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22914126 ↗MalfunctionAug 11, 2025Crack; Crack
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC WAS CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22771088 ↗MalfunctionAug 8, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC WAS SHEARED OFF. THE LENS WAS EXPLANTED, AND THE PROCEDURE WAS COMPLETED USING THE SAME MODEL LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22749349 ↗MalfunctionJul 24, 2025Product Quality Problem; Product Quality Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE DEFECTIVE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22589468 ↗MalfunctionJun 23, 2025Scratched Material; Scratched Material
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS WAS SCRATCHED ON THE OPTIC AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH AN UNSPECIFIED REPLACEMENT LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME. ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22310064 ↗MalfunctionJun 13, 2025Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH OR MARK WAS NOTICED ON THE LENS DURING LOADING, WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. IN THE SURGEON¿S OPINION, THE PRODUCT DID NOT CONTRIBUTE TO OR CAUSE THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22204113 ↗MalfunctionJun 6, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BROKE OFF THE LENS. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22157799 ↗MalfunctionJun 6, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED AS LENS FAULTY (NOT HAPTIC) / LENS COULD NOT BE USED, LENS SCRATCHED IN DELIVERY SYSTEM. LENS HAD TO BE REMOVED AND REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22156009 ↗MalfunctionMay 26, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22084349 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.