Clareon CCWTT3 (UDI 00380652457408)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652457408), received between Jan 6, 2023 and Feb 19, 2026 — classified as 15 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Device Difficult to Setup or Prepare; Material Split, Cut or Torn

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LOADING ERROR AND LENS WAS TORN AND DOCTORS DISPOSED OF THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24397846 ↗
• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT NEVER HAD GOOD VISION SINCE THE SURGERY. SHE STATED THEY WERE UNABLE TO CORRECT HER VISION AND POSSIBLY HAD MACULAR DEGENERATION. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR LEFT EYE.

  Patient problems: Retinal Degeneration; Visual Impairment

  MAUDE report 23555648 ↗
• InjuryAug 11, 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 EXPERIENCED SEVERE CORNEAL EDEMA AT TWO WEEK POST-OPERATIVE MARK. THE PATIENT ALSO HAD EXTREMELY LIMITED VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2.

  Patient problems: Blurred Vision; Corneal Edema

  MAUDE report 22770773 ↗
• InjuryJul 22, 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, THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS WITH THE REASON OF HALOS CONSTANTLY WITH BLURRY VISION, IMPACTING DAILY LIFE. CLINICAL REASON FOR EXPLANT MENTIONED AS DYSPHOTOPSIA. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE LENS WERE REPLACED WITH NONCOMPANY LENS. THE PATIENT HAD GOOD POSTOPERATIVE APPEARANCE WORKING ON OCULAR SURFACE WITH NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 22565536 ↗
• InjuryJul 11, 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, PATIENT HAD ANISOMETROPIA AND DIPLOPIA. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 22487842 ↗
• InjuryJun 30, 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, THE PATIENT EXPERIENCED EXTREME HALO, GLARE, POOR VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22358800 ↗
• InjuryMay 26, 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 EXPERIENCED BLURRED VISION. CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 3 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22084947 ↗
• InjuryMay 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT HAD GLARE AND HALOS. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANTATION AS THE PATIENT WAS NOT NEURO-ADAPTING AND OTHER MECHANICAL COMPLICATION OF IOL.

  Patient problems: Visual Disturbances

  MAUDE report 22084895 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON BEING MENTIONED AS POSTERIOR HEALING OF IOL (INTRAOCULAR LENS) WITH HYPEROPIC SHIFT. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 21992763 ↗
• MalfunctionMay 8, 2025Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED IN INITIAL PROCEDURE DUE TO LENS NOTED TO BE SCRATCHED AFTER INSERTION INTO EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21985710 ↗
• MalfunctionJan 3, 2025Material Twisted/Bent; Material Twisted/Bent

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LEADING HAPTIC WAS TWISTED DURING LOADING. THE TECH TRIED TO CURVE IT TO IT¿S NATURAL POSITION BUT IT DID NOT STAY IN THAT WAY. HENCE THE PHYSICIAN DECIDED TO REPLACE THE LENS WITH ANOTHER LENS.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21067086 ↗
• 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 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 LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20143382 ↗
• InjuryAug 28, 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 HAD DEBILITATING GLARE AND HALOS. THE LENS WAS EXCHANGED FOR AN UNKNOWN MONOFOCAL INTRAOCULAR LENS 3 MONTHS AND 2 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. THIS REPORT IS ASSOCIATED WITH TWO COMPLAINTS. THIS FILE IS FOR RIGHT EYE. ADDITIONAL INFORMATION RECEIVED STATING THAT THE LENS WAS EXCHANGED WITH ANOTHER MODEL AND DIOPTER OF SAME COMPANY LENS.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 20083589 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS MECHANICAL COMPLICATION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 19458710 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED LIGHT GLARE AND HALOS. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR THE EXPLANT WAS PHOTOPSIA AND DECREASED QUALITY OF VISION. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 18874629 ↗
• InjuryOct 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED CAPSULAR PHIMOSIS AND POST OPERATIVE 1 MONTH, THE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/20 FOR BOTH THE EYES AND POST OPERATIVE 2 MONTH, THE BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/30.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 17931001 ↗
• InjurySep 12, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE DUE TO INCORRECT DIOPTER. THE CLINICAL REASON FOR EXPLANT WAS ALSO INCORRECT DIOPTER. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17727737 ↗
• InjuryJan 6, 2023Adverse 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 WAVY VISION, POOR VISION, DISSATISFACTION AND HALOS. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 20 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM REPORTED. THE LENS WAS REPLACED WITH NON COMPANY MONOFOCAL IOL.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 16112284 ↗