Clareon CCWTT4 (UDI 00380652457996)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652457996), received between Jun 26, 2023 and Dec 5, 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 5, 2024Adverse 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, PATIENT VISION NOT CLEAR ENOUGH TO DRIVE AND BLURRINESS WAS CONSTANT. THE LENS WAS EXCHANGED WITH AN UNKNOWN TORIC IOL AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON WAS MULTIFOCAL INTOLERANCE. ADDITIONAL INFORMATION RECEIVED STATING THAT THE IOL WAS REPLACED WITH COMPANY ANOTHER MODEL LENS WITH HALF DIOPTER LESS.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20858296 ↗
• 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 2 MONTHS AND 10 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 20139512 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE PATIENT HAD -1.25D MISS AFTER THE IMPLANTATION OF THE INTRAOCULAR LENS. THE PATIENT SHOWED NO REMARKABLE OCULAR PATHOLOGY PRIOR TO SURGERY, INCLUDING NO DRY EYE SYNDROME (DES), CORNEAL OR RETINAL ISSUE OF ANY KIND. ONE MONTH POST OPERATIVELY, THE PATIENT SHOWED TWO LINES LOSS IN BEST-CORRECTED VISUAL ACUITY (BCVA). THE SURGEON NOTED THAT THERE WERE NO ABNORMALITIES DURING THE SURGERY. WHEN ANALYZING THE SURGICAL IMAGES, THERE WAS NOTHING NOTABLE THAT STANDS OUT. THE SURGEON HAD GOOD VARIABLE CONTROL THROUGHOUT EACH CAPTURE, ASIDE FROM A SINGLE SMALL BUBBLE PRESENT AND POSSIBLE ENDOTHELIAL CELLS IN THE FRINGE PATTERN. ALL IMAGES WERE EXTREMELY CONSISTENT. THERE WERE NO ERRORS FOR ANY MEASUREMENTS OR DATA AS COMPARED TO THE TESTING RESULTS. POST OPERATIVELY, THERE WAS NO CORNEAL OR RETINAL PATHOLOGY PRESENT. THE EYE WAS QUIET WITHOUT ANY FLARE AND THE PATIENT HAS NO DRY EYE SYNDROME SYMPTOMS. SINE THERE WAS NO OBVIOUS ERROR CONTRIBUTING TO THE REFRACTIVE MISS, THE SURGEON WILL WAIT TO PROCEED WITH A POSSIBLE LENS EXCHANGE UNTIL ALL ADDITIONAL TESTING EVALUATIONS AND CONSULTATIONS ARE COMPLETED.

  Patient problems: Visual Impairment

  MAUDE report 17198161 ↗