Clareon™ CC60WF (UDI 00380652396868)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. Most of the 51 reports describe problems noticed during or after implantation — the lens surface being scratched, cracked or bent, or not delivered properly — with a few patients reporting glare, light sensitivity and corneal swelling. Five reports involve injuries and no deaths are described. No recalls name this lens.
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
- 51
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 00380652396868), received between Jun 22, 2022 and Sep 25, 2026 — classified as 5 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (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
- Scratched Material13
- Break7
- Failure to Deliver5
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem4
- Defective Device4
- Crack3
- Material Deformation3
Patient problems
- Insufficient Information29
- No Clinical Signs, Symptoms or Conditions19
- Visual Disturbances4
- Corneal Edema1
- Inflammation1
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been received and stated that there has been no visual impact to patient.There are multiple medical reports associated with same event. This file is 24 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896376 ↗MalfunctionJul 27, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50017996 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, PHOTOPHOBIA AND COULDN'T GO OUT IN THE SUN BECAUSE IT WAS PAINFUL. DISCUSSED THIS WITH THE SURGEON BUT HAS NOT HAD ANY IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Visual Disturbances
MAUDE report 25637476 ↗InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, PHOTOPHOBIA AND COULDN'T GO OUT IN THE SUN BECAUSE IT WAS PAINFUL. DISCUSSED THIS WITH THE SURGEON BUT HAS NOT HAD ANY IMPROVEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Visual Disturbances
MAUDE report 25637141 ↗MalfunctionApr 24, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, CENTER OPTIC WAS SCRATCHED. THE LENS WAS EXPLANTED AND REPLACED WITH SAME MODEL LENS DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24976606 ↗MalfunctionApr 11, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED VIA REPLY CARD AS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24852061 ↗MalfunctionApr 2, 2026Product Quality Problem
A NURSE REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE SURGEON DIDN'T LIKE THE WAY THE LENS LOOKED, IT LOOKED WEIRD. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A BACKUP LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24768030 ↗MalfunctionMar 30, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL HAD SCRATCHES ON PERIPHERY AND THE IOLS REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24714440 ↗MalfunctionMar 13, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING SURGERY WITH A DESCRIPTION OF HAPTIC KINKED IN PACKAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24597533 ↗MalfunctionFeb 26, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED DURING LOADING. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24455604 ↗MalfunctionFeb 5, 2026Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED VIA REPLY CARD DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 24268797 ↗MalfunctionJan 16, 2026Packaging Problem; Inaccurate Information
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE STAFF IN THE ROOM REPORTED THAT THE BOX WAS SEALED, BUT WHEN IT WAS GIVEN TO THEM BOTH SIDE SEALS WERE OPEN. HENCE, THEY ASSUMED THAT HAVE BEEN PREVIOUSLY OPENED SINCE THE SERIAL NUMBERS ON THE BOX AND LENS DID NOT MATCH, AND STICKERS WERE MISSING, BUT IT NOT OUR PRACTICE TO KEEP THE LENS NOT IMPLANTED. SO, IF ONE WERE OPENED AND THEN THE PHYSICIAN WERE TO CHANGE THE LENS, THAT PRODUCT WOULD HAVE BEEN DISPOSED OF. THE SERIAL NUMBERS ON THE BOX AND LENS DID NOT MATCH ANYTHING WE HAVE DOCUMENTED AS IMPLANTED OR WASTED EITHER. WE TRIED TO RULE THAT OUT INITIALLY AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093163 ↗MalfunctionJan 16, 2026Packaging Problem; Inaccurate Information
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE STAFF IN THE ROOM REPORTED THAT THE BOX WAS SEALED, BUT WHEN IT WAS GIVEN TO THEM BOTH SIDE SEALS WERE OPEN. HENCE, THEY ASSUMED THAT HAVE BEEN PREVIOUSLY OPENED SINCE THE SERIAL NUMBERS ON THE BOX AND LENS DID NOT MATCH, AND STICKERS WERE MISSING, BUT IT NOT OUR PRACTICE TO KEEP THE LENS NOT IMPLANTED. SO, IF ONE WERE OPENED AND THEN THE PHYSICIAN WERE TO CHANGE THE LENS, THAT PRODUCT WOULD HAVE BEEN DISPOSED OF. THE SERIAL NUMBERS ON THE BOX AND LENS DID NOT MATCH ANYTHING WE HAVE DOCUMENTED AS IMPLANTED OR WASTED EITHER. WE TRIED TO RULE THAT OUT INITIALLY AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093138 ↗MalfunctionJan 2, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE HAPTIC WAS BENT WHEN LOADING. THE SURGERY WAS COMPLETED WITH THE COMPANY REPLACEMENT LENS. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23942495 ↗MalfunctionDec 2, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23692596 ↗MalfunctionOct 28, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS ON THE TABLE FOR SURGERY. WHEN THE LENS WAS BEING LOADED, THE DOCTOR NOTICED THAT THE HAPTIC WAS BENT. THERE HAD BEEN NO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23402380 ↗MalfunctionSep 17, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS DEFECTIVE, STUCK/JAMMED IN CARTRIDGE. THE PROCEDURE WAS COMPLETED USING UNSPECIFIED BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23072512 ↗MalfunctionAug 29, 2025Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use; Scratched Material
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED SURGEON NOTICED SCRATCH ON LENS PRIOR TO IMPLANT UPON OPENING. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22921753 ↗MalfunctionAug 19, 2025Device Damaged Prior to Use; Scratched Material; Device Damaged Prior to Use; Scratched Material
ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THE SCRATCH ON THE LENS WAS NOTICED UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22840023 ↗MalfunctionAug 11, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A LOADING ERROR OCCURRED DUE TO PLUNGER OVERRIDE, REQUIRING A REPLACEMENT LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771084 ↗MalfunctionJul 22, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS BROKEN WHEN INJECTED INTO THE EYE. THE LENS WAS THEN EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22566565 ↗MalfunctionJul 21, 2025Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE LENS WAS SCRATCHED DURING LOADING THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22556405 ↗MalfunctionJul 15, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED THAT THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22506495 ↗MalfunctionJul 14, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS HAPTIC WAS TORN. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH ANOTHER LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 22494422 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED VISUAL DISTURBANCES. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE.
Patient problems: Visual Disturbances
MAUDE report 22156503 ↗
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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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