Clareon CCW0T3 (UDI 00380652431910)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652431910), received between Feb 18, 2025 and Aug 20, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2026Scratched Material

  A nurse reported that during the intraocular lens (IOL) implantation surgery, a scratched IOL was noted once the lens was inserted into the eye. The surgeon removed the lens and replaced it with the backup lens during the same procedure. There was no patient harm. The lens was discarded and is not available for return.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50346391 ↗
• MalfunctionJan 13, 2026Failure to Deliver

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE IMPLANTING LENS IN THE EYE, THE LENS DID NOT FULLY ADVANCE AND GOT STUCK MIDWAY. SURGEONS DID NOT RISKED AND USED THE BACK-UP LENSES FOR SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24057507 ↗
• MalfunctionAug 14, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS LOADED WITH NO ISSUES, PHYSICIAN INSERTED THE LENS, AFTER THE LENS INSERTION THE BACK HAPTIC WAS TORN OFF. THE LENS WAS CUT AND REMOVED DURING INITIAL PROCEDURE AND A NEW LENS WAS INSERTED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22803875 ↗
• InjuryApr 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD SEEN YELLOW OUT OF HIS LEFT EYE. WHEN COMPARED BOTH EYES, SEES YELLOW FROM LEFT EYE. PATIENT VISION WAS VERY GOOD BESIDES THIS. PATIENT HAD YAG CAPSULOTOMY IN BOTH EYES. PATIENT CLINICAL TESTING WAS WITHIN NORMAL LIMITS (WNL). ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21908020 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE THAT THE IOL WAS EXCHANGED FOR TORIC ONE DIOPTER HIGH POWER LENS INDICATING THE CORRECT LENS POWER WAS NOT IMPLANTED INITIALLY. THERE IS NO REPORTED DEFECT OR FAULT WITH THE IOL. AS PER PHYSICIAN.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21392979 ↗