Clareon CCWTT4 (UDI 00380652457774)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652457774), received between Jul 8, 2024 and Dec 30, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER SURGERY, THE PATIENT EXPERIENCED GLARE/HALOS. CLINICAL REASON BEING MENTIONED AS MECHANICAL COMPLICATION OF INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT THE LENS REPLACED WITH NON COMPANY LENS AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 21036268 ↗
• InjurySep 5, 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 6 MONTHS AND 14 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO RIGHT EYE ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20144766 ↗
• InjuryJul 8, 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 REASON AS INTOLERABLE HALOS AND CLINICAL REASON FOR EXPLANT BEING PERSISTENT DYSPHOTOPSIAS, PATIENT DISSATISFIED WITH VISUAL DISTURBANCES. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT NOTED SEEING HALOS IN DAYLIGHT AND AT NIGHT, PASSING UNDER A LIGHT SEES A REFLECTION OF THE LIGHT. INTERMEDIATE VISION WAS H AROUND WORDS AND LETTERS UP CLOSE. NIGHTTIME DRIVING WAS VERY DIFFICULT LIGHTS TEND TO FUSE TOGETHER INTO A SMEARY BLOB . AS PER SURGEON'S OPINION, PRODUCT CAUSED INTRACTABLE DYSPHOTOPSIAS. THE IOL WAS EXPLANTED AND EXCHANGED FOR WITH A DIFFERENT MODEL BUT SAME DIOPTER COMPANY LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 19691093 ↗