Clareon™ CC60WF (UDI 00380652396899)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 lens implanted in the eye during cataract surgery. The 35 reports mostly describe the lens being scratched or its little arms (haptics) breaking off or coming loose from the optic, sometimes before it goes into the eye and sometimes during surgery. Three reports involve injuries, and there are 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
- 37
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00380652396899), received between Aug 29, 2022 and Sep 22, 2026 — classified as 3 injuries, 34 malfunctions.
The most frequently reported specific device problem is “Scratched Material” (11 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 Material11
- Break10
- Defective Device5
- Material Split, Cut or Torn4
- Adverse Event Without Identified Device or Use Problem3
- Device Damaged by Another Device2
- Device Difficult to Setup or Prepare2
- Crack1
Patient problems
- Insufficient Information20
- No Clinical Signs, Symptoms or Conditions15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Eye Infections1
- Eye Irritation1
- Itching Sensation1
- Ptosis1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Split, Cut or Torn
A nurse reported that during an intraocular lens (IOL) implantation procedure, a lens was kept in a patient and was discovered to have a crack once it was sewn in. The IOL was subsequently removed and replaced with another unspecified lens during the initial implantation procedure and the procedure was completed on the same day. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50853743 ↗MalfunctionSep 18, 2026Break
A Non-Healthcare Professional reported that during the intraocular lens (IOL) implant procedure lens haptic found to be torn. The lens was implanted and removed on the same day.Additional information received and stated that, the originally scheduled procedure was completed on the same day. As per the surgeon contributory cause was Possible issue with the lens cartridge; during injection, the IOL trailing haptic stuck on the plunger. When the doctor attempted to free it with his second instrument, the trailing haptic tore off. The tech noted that the cartridge was cracked and indicated that the trailing haptic might have been stuck between the plunger and cartridge. There was no impact to the patient as the doctor was able to remove the damaged IOL immediately without issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813199 ↗MalfunctionApr 22, 2026Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH NOTED AFTER INSERTING LENS. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956270 ↗MalfunctionApr 13, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS IMPLANTED BY THE DOCTOR, BUT IT HAD TO BE EXPLANTED AFTER IT WAS OBSERVED THAT THE HAPTIC WAS RIPPED OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24860405 ↗MalfunctionApr 10, 2026Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BRAKE OFF FROM THE OPTIC. THE HAPTIC WAS NOTICED DURING LOADING AND NEITHER WERE IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24845523 ↗MalfunctionApr 10, 2026Break
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BROKE OFF FROM THE OPTIC AND IT WAS NOTICED DURING LOADING. HENCE IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24839864 ↗MalfunctionMar 3, 2026Break
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC BROKEN. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information
MAUDE report 24496497 ↗MalfunctionDec 8, 2025Break; Break
A MATERIALS MANAGER REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC CAME OFF LENS. THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23736977 ↗MalfunctionNov 18, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE SURGEON NOTICED THAT THE HAPTIC WAS NOT DAMAGED BUT WAS NOT CONNECTED TO THE OPTIC. THE LENS WAS REMOVED, AND ANOTHER LENS WAS INSERTED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23579904 ↗MalfunctionAug 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) LOADING ERROR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737286 ↗MalfunctionJul 11, 2025Break; Break
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS HAPTIC WAS TORN. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE LOADING, THE HAPTIC TORE AND WAS DAMAGED IN THE LENS HOLDER WITH NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. IN THE SURGEON'S OPINION, IT WAS UNKNOWN IF THE PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22477644 ↗MalfunctionMay 27, 2025Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22086860 ↗MalfunctionMay 15, 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 AND SCHEDULED PROCEDURE COMPLETED THE SAME DAY. SURGEON WAS UNSURE IF THE ISSUE WAS RELATED TO CARTRIDGE, LENS LOADING SYSTEM OR USER ERROR. THERE WAS NO PATIENT CONTACT THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22023973 ↗MalfunctionApr 2, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS CRACKED. THE SURGEON USED A COMPANY CARTRIDGE, AND HE SAID THE NURSE FELT UNDUE PRESSURE WHEN LOADING AND ADVANCING THE LENS TO FOLDED POSITION, LENS DID NOT SIT IN FOLDED POSITION FOR LONGER THAN 3 MINUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21755884 ↗MalfunctionMar 11, 2025Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS SCRATCH ON OPTIC, NOTICED AFTER THE IMPLANTATION OF THE LENS. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 21573281 ↗MalfunctionMar 4, 2025Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH WAS OBSERVED ON OPTIC EDGE. LENS REMAINS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21513011 ↗MalfunctionJan 13, 2025Scratched Material; Scratched Material
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, AFTER IMPLANTING THE LENS, THE PHYSICIAN NOTICED SCRATCH OR MARK ON THE OPTIC. THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21139593 ↗MalfunctionJan 10, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STATING AFTER INJECTING LENS INTO THE EYE, ONE OF THE HAPTICS WAS NOTED TO BE BROKEN OFF FROM THE OPTIC PORTION. THE LENS WAS EXPLANTED IN INITIAL PROCEDURE. SURGEON STATED LENS DAMAGE WAS DUE TO LOADER. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL.THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21127150 ↗MalfunctionDec 31, 2024Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21046962 ↗MalfunctionDec 10, 2024Scratched Material; Scratched Material
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SKIP SCRATCHES WERE IDENTIFIED AND THE IOL WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 20893708 ↗MalfunctionNov 21, 2024Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED FROM INSERTER. THE PROCEDURE WAS COMPLETED ON SAME DAY AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748367 ↗MalfunctionNov 21, 2024Defective Device; Device Damaged by Another Device; Defective Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED FROM INSERTER. THE PROCEDURE WAS COMPLETED ON SAME DAY AND THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20748312 ↗MalfunctionJun 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A BITE OUT OF HAPTIC AT JUNCTION, AND SCATTERED PIECES OF IOL MATERIAL WITH CONFIRMED PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19518688 ↗MalfunctionApr 11, 2024Scratched Material; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD SCRATCH. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19086132 ↗MalfunctionFeb 2, 2024Crack; Crack
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INSERTED WITH CRACKS ON EITHER SIDE OF IT. LENS LEFT IT IN THE PATIENT EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18629703 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
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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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