Clareon CCWET6 (UDI 00380652456364)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652456364), received between Nov 7, 2025 and Apr 10, 2026 — classified as 2 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 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.

• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  A NON-HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PATIENT EXPERIENCED BLURRY VISION FOR DISTANCE. SUBSEQUENTLY THE LENS WAS REMOVED AND REPLACED WITH COMPANY LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS RESIDUAL MYOPIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 24845656 ↗
• InjuryNov 7, 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, WHEN THE PATCH WAS REMOVED, THE PATIENT COULD ONLY SEE A WHITE BACKGROUND MUCH LIKE AN ILLUMINATED COMPUTER SCREEN OR ETCHED GLASS AND FLOATERS IN THE EYE. THE PATIENT LATER FOLLOWED UP WITH HIS DOCTOR AND HE ATTRIBUTED IT TO HIS RK (RADIAL KERATOTOMY) SURGERY PERFORMED. OVER TIME, THE WHITENESS FADED, BUT THE PATIENT CAN¿T FOCUS ANYTHING AT DISTANCE. DOCTOR ARRANGED FOR A MAGNETIC RESONANCE IMAGING (MRI) BUT NOTHING CONCLUSIVE WAS FOUND. THE PATIENT WAS REFERRED TO A RETINOLOGIST, AT HIS VISIT TOLD HIM THAT THE SURGEON THOUGHT THE LENS WAS WRONG FOR THERE WASN'T ENOUGH CONTRAST AND THERE WAS DAMAGE TO THE LINING OF THE CORNEA. THE SURGEON NOW RECOMMENDED REMOVING THE COMPANY¿S LENS AND IMPLANTING AN UNSPECIFIED MONOFOCAL LENS AND DEPENDING ON THE OUTCOME A PARTIAL CORNEA REPLACEMENT. ALL HAVE CONCLUDED THERE WAS NO MACULAR DEGENERATION AND GLAUCOMA. EYE PRESSURES NORMAL. ADDITIONALLY, THE PATIENT REPORTED HAVING ASTIGMATISM. THE SURGEON NOTED THAT THE CELLS ON THE INSIDE OF THE CORNEA ARE ONLY 75% AND IT MAY NEED A PARTIAL CORNEA TRANSPLANT. HENCE THE LENS WAS EXPLANTED AND REPLACED

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment; Vitreous Floaters

  MAUDE report 23496449 ↗