Clareon™ CC60WF (UDI 00380652396943)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00380652396943), received between Sep 15, 2022 and Dec 30, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2025Break; Break

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC BROKEN PRIOR TO GOING IN EYE.

  Patient problems: Insufficient Information

  MAUDE report 23921080 ↗
• MalfunctionDec 24, 2025Product Quality Problem; Product Quality Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS THICKER AND PATIENT MOVED WHEN LOADING LENS SLIPPED OUT OF INJECTOR. THERE WAS PATIENT CONTACT PROCEDURE WAS COMPLETED WITH REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888207 ↗
• MalfunctionDec 5, 2025Material Deformation; Material Deformation

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS WAS DAMAGED UNTIL IT WAS IMPLANTED INTO THE EYE. THE PACKAGE DIDN'T SHOW ANY DAMAGE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23724623 ↗
• MalfunctionApr 17, 2025Product Quality Problem; Product Quality Problem

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DELIVERY SYSTEM FAULTY OR FAILED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS FILE IS 2 OF 2.

  Patient problems: Insufficient Information

  MAUDE report 21856854 ↗
• MalfunctionApr 17, 2025Failure to Deliver; Failure to Deliver

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER SLIDES PAST THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21856267 ↗
• MalfunctionJan 14, 2025Unintended Ejection; Unintended Ejection

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INCISION WAS NOT ENLARGED USING THE CARTRIDGE. HENCE THE LENS WAS NOT IMPLANTED IN THE PATIENT'S EYE, IT WAS ONLY HALFWAY INJECTED OUT OF DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 21147084 ↗
• MalfunctionNov 14, 2024Device Damaged by Another Device; Device Damaged by Another Device

  A NURSE REPORTED THAT DURING LOADING PROCESS THE WAS SCRATCHED DUE TO MALFUNCTIONING FORCEPS. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION RECEIVED IT STATES THAT THE LENS WAS SCRATCHED DUE TO NON-COMPANY FORCEPS.

  Patient problems: Insufficient Information

  MAUDE report 20688148 ↗
• MalfunctionSep 26, 2024Crack; Crack

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, INSERTED LENS WITH CARTRIDGE, LENS CAME OUT CRACKED IN MULTIPLE PLACES. HAD TO CUT LENS IN HALF AND REMOVE. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH SAME COMPANY MODEL AND DIOPTER LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310805 ↗
• MalfunctionAug 3, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF TORN OR BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED DURING SURGERY THE LENS WAS SPLIT WHEN PUTTING INTO THE EYE WITH PATIENT CONTACT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17451736 ↗
• MalfunctionMar 1, 2023Crack; Crack

  A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE 5 LITTLE CRACKS WAS OBSERVED IN OPTIC, THE LENS WAS CUT IN HALF AND REMOVED. A REPLACEMENT LENS WAS USED, AND EVERYTHING WAS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED AND WAS FURTHER CLARIFIED THAT THE LENS HAD FIVE SCRATCHES IN THE VISUAL AXIS. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH A REPLACEMENT LENS. AS PER THE SURGEON THE CARTRIDGE MAY HAVE HAD DEFECTS THAT SCRATCHED THE SURFACE OF THE LENS AS THE LENS MOVED THROUGH THE CARTRIDGE. THE LENS WAS IN THE INJECTOR FOR ABOUT THREE MINUTES AND SUFFICIENT AMOUNT OF VISCOELASTIC WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16458255 ↗
• MalfunctionSep 15, 2022Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS FOUND THAT IOL WAS SCRATCHED. THE IOL REPLACED WITH ANOTHER IOL DURING INITIAL PROCEDURE ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427672 ↗