Clareon CCWTT4 (UDI 00380652457880)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652457880), received between Oct 12, 2022 and Nov 21, 2025 — classified as 5 injuries, 2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 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 VISION WAS NOT CLEAR. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL LENS 5 MONTHS 4 WEEKS 1 DAY FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23618884 ↗
• InjuryNov 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT'S VISION WAS NOT AS EXPECTED. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 23540406 ↗
• MalfunctionApr 29, 2025Scratched Material; Scratched Material

  A NON-HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED DURING LOADING WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21926260 ↗
• InjuryApr 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 GLARE AND VISION DECREASED. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL IN A SECONDARY PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA SECONDARY TO IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21888656 ↗
• InjuryOct 30, 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 EXPERIENCED STARBURSTS WHEN DRIVING AT NIGHT AND BLURRY VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 15 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, PATIENT EXPERIENCED BLURRED VISION UNCORRECTABLE BY REFRACTION. IN THE SURGEON¿S OPINION MULTIFOCAL TECHNOLOGY CAUSED OR CONTRIBUTED TO THE EVENTS AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20571073 ↗
• InjuryMar 11, 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 EXPERIENCED BLURRY DISTANCE VISION AND BLURRY VISION WHEN READING. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 06 MONTHS 20 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT, PATIENT ISSUES RESOLVED AND THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision

  MAUDE report 18875271 ↗
• MalfunctionOct 12, 2022Scratched Material; Scratched Material

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A SCRATCH ON THE LENS, LENS WAS REMOVED AND REPLACED WITH THE BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15586253 ↗