Clareon CNWET3 (UDI 00380652485531)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652485531), received between Apr 23, 2024 and Sep 12, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Eject” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NURSE REPORTED THAT AFTER INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT EXPERIENCED BLURRY VISION AND GLARE. THE LENS WAS REMOVED AND REPLACED WITH A MONOFOCAL LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS GENERALIZED DYSPHOTOPSIA. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE IOL EXCHANGE WAS DONE WITH A NON-COMPANY LENS. THE SURGERY WAS PERFORMED IN LEFT EYE.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 20199799 ↗
• MalfunctionAug 21, 2024Failure to Eject; Failure to Eject

  A NURSE REPORTED WITH A DESCRIPTION OF LENS DID NOT DEPLOY FOR SURGEON, THAT THE DIFFICULTY AROSE WHEN ATTEMPTING TO PUSH THE LENS THROUGH THE CARTRIDGE WITH THE INSERTER. A FEW ATTEMPTS WERE MADE AND THE INSERT INSTRUMENT WOULD NOT ENGAGE THE LENS. THE SURGEON REQUESTED THAT A NEW LENS BE USED, THE SCRUB OBTAINED THE NEW LENS, A NEW CARTRIDGE AND INSERTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20013384 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH POOR QUALITY OF VISION AND HALOS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 5 MONTHS 27 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS RESIDUAL ASTIGMATISM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Halo; Visual Impairment

  MAUDE report 19162930 ↗