Clareon™ CC60WF (UDI 00380652396813)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 Clareon CC60WF intraocular lens is an Alcon implantable lens. Most reports describe scratches, breaks, or other material damage noticed during implant surgery, with some haptic or optic damage and occasional vision problems. There are 39 adverse event reports, no deaths, and 2 injuries. No FDA 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
- 39
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 00380652396813), received between Jun 23, 2022 and Aug 27, 2026 — classified as 2 injuries, 37 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (14 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 Material14
- Break4
- Material Split, Cut or Torn4
- Device Contamination with Chemical or Other Material3
- Material Twisted/Bent3
- Adverse Event Without Identified Device or Use Problem2
- Defective Device2
- Failure to Deliver2
Patient problems
- Insufficient Information20
- No Clinical Signs, Symptoms or Conditions17
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 39 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2026Material Twisted/Bent
A nonhealth care professional reported that during the intraocular lens (IOL) implantation surgery, the loading haptic was not folded properly and there was no patient contact.Additional information was received stating that, the issue occurred during loading.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474922 ↗MalfunctionJul 10, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25776784 ↗MalfunctionMay 19, 2026Scratched Material
A NURSE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, OPTIC WAS DAMAGED. THE IOL WAS SUBSEQUENTLY REMOVED DURING INITIAL IMPLANTATION PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25215245 ↗MalfunctionMay 5, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH NOTICED DURING SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25084237 ↗MalfunctionMar 18, 2026Break
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED AFTER INSERTION OF THE LENS THE END OF THE TRAILING HAPTIC WAS BROKEN OFF AND STUCK TO THE BODY OF THE LENS. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24626322 ↗MalfunctionMar 13, 2026Break
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS FOUND TO HAVE MISSING THE HAPTIC. THIS LENS WAS NOT REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24588815 ↗MalfunctionFeb 10, 2026Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE HAPTIC CRIMP NOTED UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24304316 ↗MalfunctionDec 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON INITIAL INSPECTION PRIOR TO LOADING, LENS NOTED TO BE INTACT. LOADED PROPERLY PER COMPANY INSTRUCTIONS. UPON INSERTION INTO THE CHAMBER, LENS NOTED TO HAVE TWO CRACKS. CRACKS LOCATED OUTSIDE THE VISUAL FIELD AND SURGEON OPTED TO LEAVE CRACKED LENS WITH NO CONCERNS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM. PATIENT UNDERSTOOD HIS CONDITION AND PROGNOSIS AND NEED FOR FOLLOW UP CARE. PATIENT HEALING WELL AND STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789079 ↗MalfunctionOct 15, 2025Product Quality Problem; Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS WAS STIFF AND HAD LOADING ERROR. ADDITIONAL INFORMATION WAS REQUESTED, RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23290370 ↗MalfunctionSep 19, 2025Scratched Material; Scratched Material
A REGISTERED NURSE REPORTED THAT DURING IMPLANTATION OF INTRAOCULAR LENS (IOL), A SCRATCH WAS NOTED ON THE OPTIC AFTER LENS WAS PLACED IN THE EYE. THE LENS WAS REMOVED DURING THE SAME SURGERY, AND A NEW LENS WAS PLACED WITHOUT INCISION ENLARGEMENT. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23093531 ↗MalfunctionJul 4, 2025Failure to Fold; Failure to Deliver; Failure to Fold; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AFTER PLACING THE INSERTER IN THE ANTERIOR CHAMBER OF THE PATIENT'S EYE, LENS FAILED TO LEAVE THE CARTRIDGE. IN THE SURGEON'S OPINION, INCORRECTLY FOLDED LENS, INSIDE THE CARTRIDGE CAUSED OR CONTRIBUTED TO THE EVENT. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22402128 ↗MalfunctionJun 5, 2025Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE ON BEHALF OF THE FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED WHILE LOADING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22152083 ↗MalfunctionMay 22, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS DIFFICULTY LOADING LENS IN TO THE CARTRIDGE AND A SCRATCH WAS OCCURRED AFTER LENS INSERTION. THERE WAS PATIENT CONTACT AND SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, SURGEON HAD TO CUT AND EXPLANTED THE LENS IN INITIAL PROCEDURE. THE SYMPTOMS WERE RESOLVED AND THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22070310 ↗MalfunctionMay 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS TORN. THE PROCEDURE WAS COMPLETED AND THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22017056 ↗MalfunctionFeb 25, 2025Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DOCTOR NOTICED A SCRATCH ON THE LENS ONCE INSERTED INTO THE EYE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH SAME COMPANY LENS MODEL AND DIOPTER. ADDITIONAL INFORMATION RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458781 ↗MalfunctionFeb 24, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN INJECTED THE LENS WITHOUT THE TRAILING HAPTIC. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21445669 ↗MalfunctionFeb 10, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT THE LEADING HAPTIC TORE OFF WHILE LOADING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED STATING THAT THE PROCEDURE WAS COMPLETED ON SAME DAY. IN THE SURGEON'S OPINION THE CAUSE OF THE EVENT WAS UNSURE. POSSIBLY TECH ERROR, NOT ENOUGH VISCOELASTIC OR HAPTIC WAS DAMAGED OUT OF THE BOX BUT NOT SEEN BY PROCEDURE TECH LOADING THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341831 ↗MalfunctionDec 30, 2024Material Twisted/Bent; Material Twisted/Bent
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21033988 ↗MalfunctionDec 10, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN INITIAL PROCEDURE DUE TO SCRATCHES ON LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 20893693 ↗MalfunctionOct 22, 2024Defective Component; Defective Component
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE HAPTIC WAS DEFECTIVE, NOT WORKING CORRECTLY WITH CONFIRMED NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20509189 ↗MalfunctionSep 17, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS GOT STUCK IN THE LOADER. THERE WAS PATIENT CONTACT (JUST THE TIP). ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20238520 ↗MalfunctionSep 12, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20206972 ↗InjuryAug 20, 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 09 MONTHS 29 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Disturbances
MAUDE report 20006233 ↗MalfunctionAug 13, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY WERE UNABLE TO GET IMPLANT TO UNFOLD IN THE EYE. TRAILING HAPTIC WAS STUCK TO CENTER OF IMPLANT UPON INSERTION. SURGEON WAS ABLE TO GRASP THE END OF THE IMPLANT AND PULL IT OUT OF THE PRIMARY WOUND WITHOUT CUTTING THE IOL INTO PIECES. NEW IOL USED INSTEAD. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19973833 ↗MalfunctionAug 13, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS IMPLANTED WITH NOTED DEFECT. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19970223 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.