Clareon CNWTT0 (UDI 00380652407960)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652407960), received between Feb 10, 2023 and Sep 11, 2025 — classified as 5 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. How this data works · Data updated Oct 13, 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.

• InjurySep 11, 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, PATIENT EXPERIENCED GLARE AND HALOS. THE LENS WAS EXPLANTED AND EXCHANGED 4 MONTHS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS MECHANICAL COMPLICATION OF IOL. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THE SYMPTOMS HAS BEEN RESOLVED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: Visual Disturbances

  MAUDE report 23024270 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CONSUMER REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HER VISION CLARITY FOR CLOSE, MID AND DISTANCE NEVER IMPROVED PAST A WEAK 20/40 DISTANCE AND VISUAL ACUITY WAS NOT AS EXPECTED. IT WAS ALSO STATED THAT POST OPERATION SHE WAS EXPERIENCING HAZY VISION AND ALSO THERE WAS CONSTANT FEELING OF DISCOMFORT IN OUTER MID TO LOWER PART OF EYEBALL. IN THE SECOND WEEK PRESSURE NORMAL RANGE, VISUAL ACUITY STILL NOT IMPROVED AT CLOSE, MID OR DISTANCE. FEELING OF DISCOMFORT IN OUTER MID/LOWER PART OF EYEBALL REMAINING, VERY BLURRY 20/40 WAS NOTED AT DISTANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE SURGEON BELIEVE THE PATIENT WAS JUST UNABLE TO TOLERATE THE MULTIFOCAL NATURE OF THE LENS, CONTRIBUTING TO HER DISSATISFACTION AT ALL DISTANCES.

  Patient problems: Blurred Vision; Eye Irritation; Visual Impairment

  MAUDE report 21985785 ↗
• InjuryJan 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED WAXY VISION .THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision

  MAUDE report 18482191 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE IOP RESOLVED AFTER 8 DAYS WITH IOP LOWER DROPS. AS PER INVESTIGATOR THE REPORTED EVENT TO BE MILD AND NON SERIOUS. THERE WAS CAUSAL RELATIONSHIP WITH THE DEVICE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16353772 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THE IOP RESOLVED AFTER 8 DAYS WITH IOP LOWER DROPS. AS PER INVESTIGATOR THE REPORTED EVENT TO BE MILD AND NON SERIOUS. THERE WAS CAUSAL RELATIONSHIP WITH THE DEVICE.

  Patient problems: Intraocular Pressure Increased

  MAUDE report 16353771 ↗