Clareon CCWTT0 (UDI 00380652413732)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00380652413732), received between Sep 16, 2022 and Aug 19, 2025 — classified as 10 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Scratched Material” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 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 HAD BLURRY VISION. THE IOL WAS EXCHANGED FOR UNSPECIFIED ADVANCED TECHNOLOGY INTRAOCULAR LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS RESIDUAL REFRACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXCHANGED FOR DIFFERENT MODEL SAME COMPANY AND DIOPTER LENS. THERE WAS NO PATIENT HARM POST EXCHANGE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22839465 ↗
• InjuryMay 5, 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 WAS HAVING GLARE. CLINICAL REASON IS PATIENT WAS UNHAPPY WITH VISION. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) 7 MONTHS 3 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21961046 ↗
• 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 3 MONTHS AND 15 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20144676 ↗
• 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 3 MONTHS AND 15 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS MALADAPTATION. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 20133392 ↗
• InjurySep 4, 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 HAD MALADAPTATION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER UNSPECIFIED LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS FILE BELONGS TO LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 20133390 ↗
• MalfunctionJul 31, 2024Scratched Material; Scratched Material

  A NON-HEALTH CARE PROFESSIONAL FROM HEALTH AUTHORITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD A SCRATCH. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19870714 ↗
• InjuryDec 18, 2023Adverse 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 WAS NOT HAPPY WITH THE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 2 MONTHS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 18343934 ↗
• InjuryNov 21, 2023Adverse 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 GLARE, HALOS AND NOT CRISP VISUAL ACUITY AT DISTANCE. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS RINGS AND RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IOL WAS EXCHANGED FOR ANOTHER MODEL COMPANY LENS. THERE WAS NO PATIENT HARM. IN THE SURGEON¿S OPINION RINGS ON IOL AND RESIDUAL REFRACTION CAUSED THE EVENT.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 18180544 ↗
• MalfunctionOct 31, 2023Scratched Material; Scratched Material

  A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A SCRATCH ON THE LENS. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THERE WAS NO INCISION ENLARGEMENT. CAPSULAR BAG WAS INTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18037066 ↗
• InjuryOct 20, 2023Adverse 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 GLARE &HALOS. CLINICAL REASON BEING GLARE &HALOS. 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 LENS WAS EXCHANGED FOR A NON COMPANY LENS AND THERE WAS NO PATIENT HARM.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 17976713 ↗
• InjuryOct 17, 2023Adverse 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 GLARE & HALOS. CLINICAL REASON BEING PATIENT HYPEROPIC. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances; Visual Impairment

  MAUDE report 17950343 ↗
• MalfunctionNov 8, 2022Defective Device; Defective Device

  A NON-HEALTH CARE PROFESSIONAL REPORTED TWO LENSES THAT WERE DESTROYED. ADDITIONAL INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 15751032 ↗
• InjurySep 16, 2022Break; Break

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR VISION AND NO VISUAL IMPROVEMENTS 1 MONTH POST OP AND ALSO 1 OF THE HAPTICS WAS BROKEN OFF UPON INSPECTION UNDER THE SCOPE. THE IOL WAS EXCHANGED FOR ANOTHER LENS APPROXIMATELY 1 MONTH FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WILL BE REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 15436395 ↗