Clareon CCWET3 (UDI 00380652455282)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652455282), received between Dec 28, 2022 and Aug 6, 2025 — classified as 8 injuries, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2025Device Damaged by Another Device; Device Damaged by Another Device

  A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED LENS WAS SCRATCHED BY INJECTOR. THE LENS WERE INSERTED AND REMOVED DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 22724855 ↗
• InjuryFeb 12, 2025Scratched Material; Scratched Material

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT IMPACT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363758 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED POOR VISION. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS WRONG LENS POWER.

  Patient problems: Visual Disturbances

  MAUDE report 21065184 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD POOR QUALITY VISION IN ALL FIELDS. THE IOL WAS EXCHANGED FOR UNSPECIFIED ATIOL LENS. CLINICAL REASON FOR EXPLANT MENTIONED AS INCORRECT IOL SELECTION PRE-OP. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 20237738 ↗
• InjuryMay 1, 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 GLARE. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 11 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 3 FILES.

  Patient problems: Visual Disturbances

  MAUDE report 19219652 ↗
• InjuryMay 1, 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 GLARE. THE LENS WAS EXCHANGED FOR ANOTHER COMPANY LENS MODEL 11 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM REPORTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Visual Disturbances

  MAUDE report 19219594 ↗
• InjuryFeb 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT, FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED BLURRED VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND EXCHANGED FROM 20.0 ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) TO 19.5 MONOFOCAL MODEL APPROXIMATELY TWO MONTHS AFTER INITIAL IMPLANTATION. THE CLINICAL REASON FOR THE EXPLANT WAS REPORTED AS REFRACTIVE ERROR. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT EXPERIENCED QUALITY OF VISUAL ACUITY WAS BLURRY WITH NEAR AND DISTANCE VISION WITH IOL IN SETTING OF PREVIOUS LASIK BUT NOT A DEFECT WITH THE COMPANY IOL. AFTER EXCHANGING WITH NON COMPANY 19.5 MONOFOCAL LENS PATIENT'S ISSUES RESOLVED AND SURGEON'S PROGNOSIS WAS EXCELLENT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 18684967 ↗
• MalfunctionApr 25, 2023Break; Break

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS FRACTURE IN OPTIC. HENCE IT WAS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808113 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION STATED THAT PATIENT'S RIGHT EYE WAS INVOLVED. IN SURGEON'S OPINION, PATIENT WAS ORIGINALLY THOUGHT TO BE POST MYOPIC LASIK AND IN RETROSPECT WAS POST HYPEROPIC LASIK AND SURGEON BELIEVED THAT COMPANY IOL DID NOT WORK WELL WITH A POST HYPEROPIC CORNEA CAUSING POOR BEST CORRECTED VISUAL ACUITY. PATIENT'S ISSUES HAD BEEN RESOLVED.

  Patient problems: Blurred Vision

  MAUDE report 16742148 ↗
• InjuryDec 28, 2022Adverse 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 DIDN¿T LIKE, THE LENS WAS REPLACED WITH MONOFOCAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 16062942 ↗