Clareon™ CC60WF (UDI 00380652396790)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
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon CC60WF is a foldable plastic lens implanted in the eye during cataract surgery. The 29 reports mostly describe lens packaging and handling problems noticed during surgery: a cracked or scratched lens, a bent or torn haptic (the arm that holds it in place), or a lens stuck in its cartridge and failing to load. One report mentions blurred vision; no deaths and one injury are reported, and several notes say the surgery was completed the same day without harm. 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
- 29
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00380652396790), received between Oct 7, 2022 and Jul 30, 2026 — classified as 1 injury, 28 malfunctions.
The most frequently reported specific device problem is “Defective Device” (5 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
- Defective Device5
- Scratched Material5
- Break4
- Material Split, Cut or Torn4
- Failure to Deliver3
- Material Twisted/Bent3
- Crack2
- Material Deformation2
Patient problems
- Insufficient Information18
- No Clinical Signs, Symptoms or Conditions11
- Blurred Vision1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Break; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50086133 ↗MalfunctionJun 19, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A DAMAGED LENS WAS IDENTIFIED AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT. 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 25560389 ↗MalfunctionJun 5, 2026Material Split, Cut or Torn
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS CRACKED AT THE HAPTIC OPTIC JUNCTION AS IT EXITED THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25408536 ↗MalfunctionMay 29, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE TECH NOTED SCRATCH BEFORE IMPLANT. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25333653 ↗MalfunctionApr 27, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DAMAGED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999121 ↗MalfunctionMar 26, 2026Material Twisted/Bent
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN INSERTING THE LENS, THE HAPTIC STUCK IN CARTRIDGE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITHOUT ANY HARM TO THE PATIENT. IN THE SURGEON¿S OPINION, PROGNOSIS OF THE PATIENT WAS FAIR AND ISSUES WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24700327 ↗MalfunctionMar 13, 2026Material Deformation
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THEY NOTICED SOME DAMAGE ON THE PERIPHERY OF THE LENS IN THE 2 O¿CLOCK AREA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24588086 ↗MalfunctionFeb 17, 2026Device Difficult to Setup or Prepare; Failure to Deliver
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS GOT STUCK IN THE CARTRIDGE AND WOULD NOT LOAD CORRECTLY.
Patient problems: Insufficient Information
MAUDE report 24364375 ↗MalfunctionJan 15, 2026Material Twisted/Bent
ADDITIONAL INFORMATION RECEIVED AND STATED THAT, HAPTIC COULD NOT LOAD PROPERLY WHILE TRYING TO LOAD IN THE CARTRIDGE. THE SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT WITH THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 24077877 ↗MalfunctionJan 13, 2026Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS APPEARED TO HAVE A FAULTY HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24053071 ↗MalfunctionAug 19, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE TRYING TO LOAD THE IOL INTO THE CARTRIDGE, IT WAS NOTICED THAT THE LENS APPEARED TO HAVE A DEFECT. THE IOL WAS HANDED TO THE SURGEON, NOT IN A CARTRIDGE, JUST THE IOL TO VIEW UNDER THE MICROSCOPE AND THE SURGEON CONFIRMED THAT THE IOL WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON SAME DAY WITH BACKUP IOL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22846410 ↗MalfunctionJun 24, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS OBSERVED THAT THE HAPTIC WAS BROKEN WHILE LOADING THE LENS. THERE WAS NO PATIENT CONTACT. A REPLACEMENT LENS WAS USED AND IMPLANTED DURING THE SAME SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22321985 ↗MalfunctionMar 10, 2025Dent in Material; Dent in Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SMALL CHIP AT PERIPHERAL EDGE OF IOL. LENS WAS LEFT IN EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21557867 ↗MalfunctionFeb 24, 2025Scratched Material; Scratched Material
PHYSICIAN REPORTED THAT REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THERE WAS SCRATCH ON OPTIC UPON THE IMPLANTATION THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21445080 ↗MalfunctionFeb 19, 2025Failure to Deliver; Material Split, Cut or Torn; Failure to Deliver; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING SURGERY, THEY HAVE NOTICED THAT CRACKS ON THE OUTER DIAMETER OF THE OPTICS WERE OBSERVED UPON IMPLANTATION. DOCTOR DIDN¿T FEEL THESE WOULD IMPACT THE PATIENT¿S VISION AND OPTED NOT TO EXPLANT THIS LENS. ALSO, STATES THAT FELT SOME ADDITIONAL RESISTANCE WHEN IMPLANTING THIS LENS. HE SAID THE TACTILE FEEL OF ADVANCING THE LENS INTO THE EYE VIA THE INSERTER FELT LIKE IT REQUIRED A LITTLE MORE FORCE THAN NORMAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21411506 ↗MalfunctionJan 7, 2025Particulates; Defective Device; Particulates; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INTRAOCULAR LENS WAS LOADED INTO THE LENS CARTRIDGE BUT PRIOR TO INSERTION IT WAS NOTED TO HAVE A DEFECT (STRING OF PLASTIC COMING OFF FROM OPTIC). SO, THIS LENS WAS REJECTED AND IT WAS NOT INSERTED INTO THE EYE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21091663 ↗MalfunctionMay 6, 2024Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) STUCK IN CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19247659 ↗MalfunctionFeb 23, 2024Failure to Advance; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE,LENS DID NOT EJECT PROPERLY. LENS WAS EXPLANTED AT INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18765514 ↗MalfunctionFeb 2, 2024Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CRACKED LENS. THERE WAS A PATIENT CONTACT. LENS WAS EXPLANTED IN A INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18629078 ↗MalfunctionNov 28, 2023Crack; Crack
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS WAS CRACKED. LENS WAS EXPLANTED DURING INITIAL PROCEDURE. REPLACED WITH COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18214114 ↗MalfunctionJul 17, 2023Particulates; Particulates
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY THEY NOTICED THAT THERE WAS COATING OR SHEEN ON THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17332422 ↗MalfunctionJun 12, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A DEFECTIVE LENS WAS OBSERVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17107616 ↗MalfunctionMay 5, 2023Defective Device; Defective Device
A DIRECTOR OF SURGERY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INJECTED AND THEN CUT OUT DUE TO LENS DAMAGE. A NEW LENS WAS OPENED AND INSERTED SUCCESSFULLY. THERE WAS A PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16875194 ↗InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT ABLE TO SEE FROM ARM LENGTH. THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS NOT NEAR ENOUGH TO PATIENTS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision
MAUDE report 16707328 ↗MalfunctionJan 18, 2023Defective Device; Scratched Material; Defective Device; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS FURTHER CLARIFIED THAT THE LENS WAS SCRATCHED DURING LOADING WITH NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 16195882 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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