Clareon™ CC60WF (UDI 00380652396851)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 implantable lens used during cataract surgery to replace the eye's natural lens. The 68 reports mostly describe lenses found scratched, cracked, bent, split, or broken while being handled or implanted, sometimes forcing doctors to remove and swap them during the same operation; some also mention blurred or distorted vision afterward. There are no deaths and 6 injuries. 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
- 68
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00380652396851), received between Jun 20, 2022 and Jul 31, 2026 — classified as 6 injuries, 62 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
- Break8
- Material Split, Cut or Torn6
- Material Twisted/Bent6
- Product Quality Problem6
- Adverse Event Without Identified Device or Use Problem5
- Crack5
- Defective Device3
Patient problems
- Insufficient Information40
- No Clinical Signs, Symptoms or Conditions22
- Visual Disturbances6
- Capsular Bag Tear2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Corneal Edema1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 31, 2026Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50097871 ↗MalfunctionJun 12, 2026Product Quality Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, LENS HAD NOTCHES ON THE BACK OF THEM. THERE ARE THREE MEDICAL REPORTS ASSOCIATED WITH SAME EVENT. THIS FILE IS OF 1 OF 3. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25482833 ↗MalfunctionJun 5, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE LENS WAS CUT AND REMOVED DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25410415 ↗MalfunctionMay 18, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL FOUND TO BE SCRATCHED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 25203710 ↗MalfunctionMay 18, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL FOUND TO BE SCRATCHED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3.
Patient problems: Insufficient Information
MAUDE report 25203703 ↗MalfunctionMay 11, 2026Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE AFTER PLACING THE IOL INTO PATIENT'S EYE, THE DOCTOR OBSERVED A DEFECT IN LENS. A NEW LENS WAS OPENED AFTER THE FIRST LENS WAS REMOVED AND PLACED SUCCESSFULLY. NO DEFECTS NOTED IN NEW LENS.
Patient problems: Insufficient Information
MAUDE report 25137568 ↗MalfunctionMay 7, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS OBSERVED TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25109309 ↗MalfunctionApr 27, 2026Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE BACK HAPTIC BECAME CAUGHT IN THE INJECTOR PLUNGER AND BROKE. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED THE SAME DAY, AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001568 ↗MalfunctionApr 24, 2026Dent in Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE EDGE OF THE LENS APPEARED MARRED. THE DEVICE MADE CONTACT WITH THE PATIENT. NO PATIENT HARM WAS REPORTED. 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 24984394 ↗MalfunctionApr 10, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE LENS WAS CUT AND REMOVED DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845653 ↗MalfunctionApr 6, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS REPORTED WITH THE DESCRIPTION OF DAMAGED BEFORE IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792137 ↗MalfunctionMar 13, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK DID NOT USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24590404 ↗MalfunctionMar 3, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE INTRAOCULAR LENS WAS INSERTED INTO THE CAPSULAR BAG, IT WAS NOTED TO BE DEFECTIVE WITH A DIFFUSE COATING OF HARD, WHITE CRYSTALLINE MATERIAL ON THE ANTERIOR FACE OF THE OPTIC. DESPITE EXTENSIVE POLISHING WITH THE IRRIGATION AND ASPIRATION UNIT, THE ABNORMAL LENS COATING COULD NOT BE REMOVED. INSTEAD, THE LENS HAD TO BE EXPLANTED, AND A NEW INTRAOCULAR LENS WAS INSERTED. DURING EXPLANTATION, THE DEFECTIVE INTRAOCULAR LENS WAS FOUND TO BE ABNORMALLY RIGID AND COULD NOT BE FOLDED OVER AN IRIS SPATULA. INSTEAD, A LENS CUTTER HAD TO BE USED TO CUT THE LENS INTO PIECES, WHICH WERE THEN REMOVED FROM THE EYE.
Patient problems: Insufficient Information
MAUDE report 24497331 ↗MalfunctionFeb 25, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE AND IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24441595 ↗MalfunctionFeb 11, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED LENS DEFECTIVE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24313798 ↗MalfunctionFeb 6, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE DEFECT ON OPTIC EDGE OBSERVED AS IMPLANTING. IOL REMAINED IN THE EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 3.
Patient problems: Insufficient Information
MAUDE report 24279152 ↗MalfunctionFeb 6, 2026Break
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS FOUND TO BE TORN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24279151 ↗MalfunctionDec 29, 2025Scratched Material; Scratched Material
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, A PHYSICIAN NOTICED A SCRATCH ON PERIPHERY OF OPTIC. HOWEVER, THE LENS REMAINED IN EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23906038 ↗MalfunctionDec 29, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE LENS OPTIC WAS BROKEN OR CRACKED. THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23906025 ↗InjuryDec 12, 2025Adverse 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 EXPERIENCED BLURRY VISION. THE LENS WAS EXPLANTED AND REPLACED WITH UNSPECIFIED LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS IOL CAME TOO STRONG. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23788871 ↗MalfunctionNov 14, 2025Scratched Material; Scratched Material
ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THE IOL WAS REPLACED WITH COMPANY LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555461 ↗InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT'S CAPSULE WAS RUPTURED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 23463883 ↗MalfunctionOct 28, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC DETACHED UPON INSERTION INTO THE PATIENT¿S EYE. ACCORDING TO FOLLOW-UP DETAILS, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23404169 ↗MalfunctionSep 2, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS TORN OR BROKEN. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE PROCEDURE WAS COMPLETED ON THE SAME DAY BY REPLACING THE LENS WITH ANOTHER LENS DURING THE SAME PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22936352 ↗MalfunctionAug 26, 2025Material Twisted/Bent; Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LEADING HAPTIC WOULD NOT REMAIN INSIDE FOLDED LENS WHILE ADVANCING IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22893033 ↗
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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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