Clareon CCWTT0 (UDI 00380652413749)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652413749), received between Oct 27, 2022 and Sep 12, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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 12, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Device Difficult to Setup or Prepare; Failure to Deliver

  ADDITIONAL INFORMATION RECEIVED STATING THAT ALL LENSES THAT WERE IMPLANTED DUE TO LENS ISSUES WERE THE SAME DIOPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036944 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS PATIENT NEEDED A TORIC LENS TO CORRECT FOR ASTIGMATISM.

  Patient problems: Blurred Vision

  MAUDE report 22299320 ↗
• MalfunctionMar 5, 2025Break; Break

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC TORN OR BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21525540 ↗
• InjuryFeb 25, 2025Adverse 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 COULD NOT TOLERATE RINGS AND HALOS. THE LENS WAS EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) AFTER THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 21457268 ↗
• InjuryNov 13, 2024Adverse 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 DECREASED DISTANCE VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MYOPIC OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 20675158 ↗
• 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.

  Patient problems: Blurred Vision

  MAUDE report 20134408 ↗
• InjuryAug 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL DISLOCATED INTO VITREOUS CAVITY AND UNABLE TO FLOAT BACK INTO ANTERIOR CHAMBER (A/C) AND POSTERIOR CAPSULE WAS RUPTURED. THE PATIENT WAS SENT TO A RETINA SPECIALIST, PATIENT HAD VITRECTOMY AND PARS PLANA LENSECTOMY OD (EXPLANT OF DISLOCATED IOL, SUTURED AND LASER). THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Capsular Bag Tear

  MAUDE report 19926347 ↗
• InjuryNov 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT HAD UNCLEAR VISION AND POSITIVE DYSPHOTOPSIA AND THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL COMPLICATION OF INTRAOCULAR LENS.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18198148 ↗
• MalfunctionFeb 13, 2023Crack; Scratched Material; Crack; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS PERIPHERALLY SCRATCHED AND CRACKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16362125 ↗
• MalfunctionOct 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  A MATERIALS MANAGER REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY FOUND SMUDGED LENS AND IT WAS REMOVED BY IRRIGATION AND ASPIRATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT FURTHER NO INFORMATION WAS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15681165 ↗