Clareon CCWET0 (UDI 00380652405621)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652405621), received between Mar 19, 2024 and Feb 21, 2026 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED POOR QUALITY VISION AND EXCESSIVE GLARE FROM LIGHTS. THE LENS WAS SUBSEQUENTLY REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS THAT THE PATIENT WAS UNABLE TO REFRACT WELL AND HAD LIMITED VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 24408633 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT EXPERIENCED POOR QUALITY VISION, EXCESSIVE GLARE FROM LIGHTS. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE UNABLE TO REFRACT VISION WELL, LIMITED ACUITY. THE IOL WAS REPLACED WITH UNSPECIFIED LENS APPROXIMATELY 6 MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 24402583 ↗
• InjuryJun 23, 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 EXPERIENCED EYE PAIN, DISCOMFORT, AND A PRESSURE FEELING FROM BEHIND THE EYE. THE PATIENT HAD A MACULAR PUCKER IN THE RIGHT EYE PRIOR TO SURGERY. THE EYE WAS TOO BIG FOR THE SOCKET. THE PATIENT HAVING ISSUES WITH THE GROUND LOOKING UNEVEN WHEN SHE GOES OUTSIDE. THE RIGHT EYE MAKES OBJECTS LOOK BIGGER. SHE CANNOT DRIVE SINCE SURGERY. THE SURGEON HAS SEEN HER MULTIPLE TIMES AND RESTARTED HER ON NONSTEROIDAL ANTI-INFLAMMATORY DRUG TO HELP WITH THE DISCOMFORT BUT MAYBE IT WAS MAKING THE EYE FEEL WORSE. SHE WAS SEEN ALSO BY HER RETINA DOCTOR WHO SAID THE MACULAR PUCKER WAS STABLE. THE PATIENT FEELS THAT EYELID DOES NOT BLINK AS IT USED TO BE. SHE HAD A LONG HISTORY OF PRODUCT AND ENVIRONMENTAL ALLERGIES AND WONDERS IF HER BODY IS ALLERGIC OR REJECTING THE LENS IMPLANT. SHE WILL SPEAK WITH HER SURGEON AT NEXT APPOINTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Eye Irritation; Eye Pain; Unspecified Eye / Vision Problem; Visual Impairment

  MAUDE report 22306766 ↗
• InjuryMar 19, 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, THERE WAS A MECHANICAL COMPLICATION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 18929692 ↗