Clareon CCWTT0 (UDI 00380652413572)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652413572), received between Dec 28, 2022 and Dec 2, 2025 — classified as 8 injuries, 2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED A BROKEN POSTERIOR CAPSULE DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE.

  Patient problems: Capsular Bag Tear

  MAUDE report 23693922 ↗
• InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION AND HAZE. THE LENS WAS EXPLANTED AND EXCHANGED WITH NEW LENS 11 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22157097 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD BLURRED VISION. THE LENS WAS EXCHANGED WITH NON-COMPANY IOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANTATION WAS NEEDED LIMBAL RELAXING INCISION.

  Patient problems: Blurred Vision

  MAUDE report 22078456 ↗
• InjuryMay 7, 2025Adverse 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 VISION HAS NOT IMPROVED AS BEFORE SURGERY, CANNOT SEE LIKE THOUGHT WOULD, NEVER BEEN GOOD AFTER SURGERY. CLINICAL REASON WAS UNABLE TO FIND ANY MEDICAL REASON FOR WHY VISION WAS POOR IN LEFT EYE. THE INTRAOCULAR LENS (IOL) WAS EXCHANGED FOR MONOFOCAL LENS MODEL 1 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 21977977 ↗
• InjuryFeb 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH BLURRY AT DISTANCE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 03 MONTHS 06 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 21292743 ↗
• InjuryJun 11, 2024Break; Optical Decentration; Material Split, Cut or Torn; Break; Optical Decentration; Material Split, Cut or Torn

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE SURGEON NOTICED THAT THE IOL WAS NOT CENTERED DURING THE PATIENTS POST OP APPOINTMENT; THE SURGEON TOOK THE PATIENT BACK TO THE OR TO TRY TO POSITION THE IOL BUT NOTICED THE LEADING HAPTIC WAS TORN. THERE WAS NO PATIENT HARM. THE SURGEON REMOVED THE IOL AND REPLACED IT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19510337 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH VISION AND HYPEROPIC RESULT. THE IOL WAS EXCHANGED FOR ANOTHER MODEL REPLACEMENT ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 2 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 18810962 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE, HALOS, NIGHT TIME DYSPHOTOPSIA. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 8 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 18605237 ↗
• MalfunctionSep 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE CONSUMER SHE WOULD NEED TO SPEAK TO HER SURGEON. SHE STATED SHE SAW A RETINAL SPECIALIST WHO RECOMMENDED SURGERY TO REMOVE IOL BUT WOULD NOT SUTURE THE COMPANY LENS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17728425 ↗
• MalfunctionDec 28, 2022Defective Device; Defective Device

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE MANUFACTURER DEFECT, NOT FROM LENS LOADING OR HANDLING. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 16060265 ↗