Clareon CCWTT3 (UDI 00380652457354)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652457354), received between Sep 6, 2023 and Apr 22, 2026 — classified as 5 injuries.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2026Device Dislodged or Dislocated

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR DISTANCE AND NEAR VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ADVANCED TECHNOLOGY INTRAOCULAR LENSES IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS POSTERIOR DISLOCATION OF THE LENS IN RIGHT EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT VITRECTOMY WAS PERFORMED. THERE WAS NO PATIENT HARM. THE PATIENT HAD GOOD PATIENT PROGNOSIS AND ISSUE WAS RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 24955243 ↗
• InjuryDec 23, 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) IMPLANTATION PROCEDURE, THE IMPLANTED IOL WAS EXPLANTED DUE TO THE PATIENT BEING UNABLE TO TOLERATE IT. THE CLINICAL REASON PROVIDED WAS THAT THE PATIENT REQUIRED A PRISM. THE LENS WAS REPLACED WITH A MONOFOCAL IOL. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 23876317 ↗
• InjuryAug 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 THE EXPLANT VISION WAS UNDER-CORRECTED. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 2 MONTHS 18 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 22895895 ↗
• InjuryOct 30, 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 BLURRY VISION/GLARE, CLINICAL REASON BEING MECHANICAL COMPLICATION OF IOL. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 18028915 ↗
• InjurySep 6, 2023Break; Malposition of Device; Break; Malposition of Device

  A HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRED VISION. HENCE THE LENS WAS REPLACED WITH ANOTHER LENS OF SAME MODEL IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR IMPLANT WAS UNEXPECTED ROTATION OF LENS. THE BROKEN HAPTIC WAS FOUND TO BE THE PROBLEM. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THERE WAS NO PATIENT HARM AND THE PATIENT'S ISSUE WAS RESOLVED. AT POST OPERATIVE VISIT, THE LENS WAS WELL CENTERED. THE SURGEON IS CONFIDENT THAT GOOD VISION WILL BE OBTAINED SIMILAR TO THE FIRST EYE.

  Patient problems: Blurred Vision

  MAUDE report 17691864 ↗