Clareon CCWET5 (UDI 00380652455923)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652455923), received between Sep 26, 2023 and Feb 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH HALOS WITH LIGHTS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 06 MONTHS 27 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS DYSPHOTOPSIA AND DOUBLE VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Diplopia/Double Vision; Visual Disturbances

  MAUDE report 24291915 ↗
• InjurySep 26, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A FACILITY REPRESENTATIVE REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED A SIGNIFICANT MYOPIC REFRACTIVE OUTCOME, SPECIFICALLY -8.00 SPHERICAL (SPH) AND -1.25 CYLINDRICAL (CYL), WHICH WAS NOT THE INTENDED RESULT. IMPORTANTLY, THE SURGERY ITSELF WAS UNCOMPLICATED, AND THE POST-OPERATIVE EXAMINATION DID NOT REVEAL ANY NOTABLE ISSUES. THE PLANNED IOL POWER FOR THE PATIENT WAS 16.0, WITH A TARGET REFRACTION OF PLANO (ZERO SPHERICAL CORRECTION) FOR DISTANCE VISION. TO INVESTIGATE THE UNEXPECTED REFRACTIVE OUTCOME, TWO SEPARATE IOL CALCULATIONS WERE PERFORMED USING DIFFERENT DEVICES, BOTH OF WHICH CONFIRMED SIMILAR AXIAL LENGTHS OF APPROXIMATELY 24MM. MOREOVER, THE KERATOMETRY READINGS OBTAINED WERE CONSISTENT WITH THE CORNEAL TOPOGRAPHY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PATIENT WAS HIGH MYOPIC SURPRISE FROM A LENS. PREOPERATIVELY, SURGEON HAVE PERFORMED TWO SEPARATE IOL CALCS FROM TWO SEPARATE MACHINES, WHICH CONFIRMED CONSISTENT AXIAL LENGTHS IN THE 24MM RANGE, AND CONSISTENT KERATOMETRY THAT MATCHED A CORNEAL TOPOGRAPHY. SURGEON CHOSEN A TORIC IOL FOR DISTANCE. THE SURGERY WAS UNCOMPLICATED, AND THE POSTOPERATIVE EXA

  Patient problems: Visual Impairment

  MAUDE report 17816155 ↗