Clareon CCWTT3 (UDI 00380652457453)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652457453), received between Nov 14, 2022 and Sep 15, 2025 — classified as 7 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Product Quality Problem; Product Quality Problem

  A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TORIC MARKINGS WERE MISALIGNED. SURGEON DID NOT FEEL COMFORTABLE USING THE LENS, REMOVED AND REPLACED WITH SAME MODEL AND DIOPTER. PATIENT HAD SLIGHT EDEMA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Corneal Edema

  MAUDE report 23052278 ↗
• InjuryJul 25, 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 BLURRY VISION. THE LENS WAS EXCHANGED WITH COMPANY SAME LENS MODEL AND DIOPTER AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS IOL COMPLICATION.

  Patient problems: Blurred Vision

  MAUDE report 22619282 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED GLARE AND HALOS. CLINICAL REASON IS DYSPHOTOPSIA .THE IOL HAS BEEN EXPLANTED IN SECONDARY PROCEDURE. FOLLOW-UP INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20735541 ↗
• InjurySep 24, 2024Adverse 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 HAD PROBLEM WITH HALOS AROUND LIGHTS. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS 2 MONTHS AND 6 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS HALOS AROUND LIGHTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo

  MAUDE report 20293226 ↗
• InjurySep 4, 2024Adverse 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 HAD MALADAPTATION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS MODEL AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20135266 ↗
• InjuryJul 31, 2024Adverse 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, THE PATIENT HAD HALOS AND GLARE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19869853 ↗
• InjuryJul 12, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON WAS MENTIONED AS DISPLACED INTRAOCULAR LENS. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19728713 ↗
• InjuryJul 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DAYTIME GLARE, BAD NIGHT GLARE, STARBURSTS, DRY EYE AND HALOS. THE PATIENT UNDERGONE FOR LASER PROCEDURE ON EYE TO CLEAN UP DEBRIS THE SURGEON SAW IN THE EYE WHICH CAUSED ME NOW TO HAVE VERY ANNOYING FLOATERS. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Dry Eye(s); Halo; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 19718746 ↗
• MalfunctionAug 10, 2023Particulates; Particulates

  A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN NOTICED POLYCHROMATIC SHEEN ON THE LENS. REPORTER DENIED TO PROVIDE FURTHER INFORMATION. THERE WERE 3 FILES ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 17497965 ↗
• MalfunctionNov 14, 2022Break; Break

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT THERE WAS CENTRAL DIVOT IN THE MIDDLE OF THE LENS. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND LENS WAS REMOVED AND REPLACED WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788362 ↗