Clareon CCWET3 (UDI 00380652455237)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652455237), received between Jun 28, 2023 and May 6, 2025 — classified as 4 injuries, 1 malfunction.

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.

• InjuryMay 6, 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 WITH POOR VISION AT DISTANCE AND NEAR. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS CANNOT GET PATIENT BETTER THAN 20/40 VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 21968855 ↗
• MalfunctionAug 14, 2024Scratched Material; Scratched Material

  A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAD A SCRATCH. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT LENS WAS REMOVED AND REPLACED WITH REPLACEMENT LENS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19983729 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT AFTER AN INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED BLURRY VISION. CLINICAL REASON FOR WAS MENTIONED AS MULTIFOCAL CORNEA OR POSTERIOR CORNEAL ELEVATION INTERFERING WITH EDOF (EXTENDED DEPTH-OF-FOCUS).THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED, PATIENT HAD CENTRAL BLUR IN VISION AND UNABLE TO SEE CLEARLY (COULDN'T READ STREET SIGNS WITH RIGHT EYE ONLY). AFTER AN IOL EXCHANGE WITH NON COMPANY LENS, ON DAY 1 POST-OP, HE REPORTED THAT THE CENTRAL BLUR WAS RESOLVED. AS PER PHYSICIAN'S OPINION MILD POSTERIOR CORNEAL ELEVATION NOTED AFTER CORNEAL SPECIALIST EVALUATION MAY HAVE PLAYED A ROLE IN THIS PATIENT'S INABILITY TO TOLERATE/FUNCTION WITH AN ADVANCED OPTICS DESIGN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 19012342 ↗
• InjuryNov 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT HE HAD CATARACT SURGERY IN HIS BOTH EYES FROM 5 WEEKS AGO, CALLER STATED THAT HIS INTERMEDIATE AND NEAR VISION ARE TERRIBLE. VISION IN THE LEFT EYE WAS 20/40 FOR DISTANCE, 20/2200 FOR CLOSE UP. HE HAD START EXPERIENCING SYMPTOMS RIGHT AFTER THE SURGERY. ALSO, STATED THAT ACCORDING TO COMPANY WEBSITE PATIENT'S CLOSE UP VISION SHOULD BE 20/30 AND INTERMEDIATE VISION SHOULD BE 20/25. THE DOCTOR TOLD THAT THE PATIENT'S CLOSE UP VISION FOR BOTH EYES WAS 20/2200. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18109888 ↗
• InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON HEALTH CARE PROFESSIONAL REPORTED THAT AFTER IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAD DECREASED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH ANOTHER LENS. THE CLINICAL REASON FOR EXPLANT WAS MECHANICAL DYSFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 17215894 ↗