Clareon CNWTT0 (UDI 00380652408066)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652408066), received between Apr 10, 2023 and Apr 3, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Product Quality 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2026Product Quality Problem

  A PHYSICIAN REPORTED THAT, THE PATIENT¿S PREOPERATIVE VISION WITH CORRECTION WAS 1.0 AND FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE PATIENT¿S VISUAL ACUITY DECREASED TO 0.7 AND COULD NOT BE IMPROVED WITH CORRECTION. ADDITIONALLY, NEAR VISION WAS REDUCED TO 0.4. THE IOL POWER CALCULATIONS WERE VERIFIED AS CORRECT; HOWEVER, THE PATIENT IS NOT SATISFIED WITH THE RESULT. THE PHYSICIAN SUGGESTED THAT THE PROBLEM WAS IN THE IOL, POSSIBLY A MANUFACTURING DEFECT.

  Patient problems: Visual Impairment

  MAUDE report 24774739 ↗
• InjuryOct 28, 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, THE PATIENT EXPERIENCED VISUAL HAZE, PHOTOPSIA, DIPLOPIA, HALOS AND DIFFICULTY READING AND DRIVING. THE SURGEON WAS PLANNING ON EXPLANTING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision; Diplopia/Double Vision; Visual Disturbances; Visual Impairment

  MAUDE report 23402017 ↗
• InjuryOct 17, 2025Adverse 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, THE PATIENT EXPERIENCED VISUAL DISTURBANCES. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Disturbances

  MAUDE report 23331431 ↗
• InjuryJun 10, 2025Adverse 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 POOR VISION AND NIGHTTIME DYSPHOTOPSIA AND CLINICAL REASON FOR EXPLANT BEING DECREASED UNCORRECTED VISUAL ACUITY. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ADVANCED TECHNOLOGY INTRAOCULAR LENS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 22175990 ↗
• InjuryMar 22, 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 EXPERIENCED COMPLAINTS OF DIFFICULTY ADAPTING TO DAILY LIFE AND ISSUES WITH LENS ADAPTATION CAUSED BY REFRACTIVE ERROR. THE IOL WAS EXCHANGED FOR ANOTHER UNSPECIFIED LENS MODEL WITHIN A MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Visual Impairment

  MAUDE report 18960891 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT UPON EXAMINATION OF EYES THE PATIENT ALSO DIAGNOSED WITH MEIBOMIAN GLAND DEFICIENCY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Posterior Capsule Opacification; Visual Impairment

  MAUDE report 18161004 ↗
• InjuryApr 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT COMPLAINED ABOUT THE POSTOPERATIVE VISION. THE LENS WAS EXPLANTED AND REPLACED WITH SINGLE FOCUS LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: Blurred Vision

  MAUDE report 16709672 ↗