Clareon CCWTT4 (UDI 00380652457972)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652457972), received between Dec 12, 2023 and Jun 23, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Scratched Material” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 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 MECHANICAL COMPLICATIONS OF IOL. THE IOL WAS EXPLANTED AND EXCHANGED WITH UNKNOWN ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 22307249 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD HALOS WHILE DRIVING AT NIGHT. THE PATIENT VISION WAS VERY GOOD FOR ALL SITUATIONS AND PATIENT WAS A QUADRIPLEGIC WHO DOES NOT DRIVE. ADDITIONAL INFORMATION HAS BEE REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 22025651 ↗
• InjuryNov 28, 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 BLURRED VISION, HAZY, HALOS. THE IOL WAS EXCHANGED FOR NON-COMPANY LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS MECHANICAL DEFECT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.

  Patient problems: Blurred Vision; Halo

  MAUDE report 20805186 ↗
• InjuryAug 7, 2024Adverse 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 GLARES AND HALOS. THE IOL WAS EXCHANGED FOR ANOTHER COMPANY LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS POSITIVE AND NEGATIVE DYSPHOTOPSIA, EXPECTED ASTIGMATISM. 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: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 19926448 ↗
• InjuryDec 12, 2023Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT POOR QUALITY OF VISION, SEEING BUBBLES IN VISION, ASTIGMATISM CORRECTION. CLINICAL REASON IOL WAS SCRATCHED UPON INITIAL IMPLANTATION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 18309674 ↗