Clareon CNWTT0 (UDI 00380652408073)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00380652408073), received between Sep 12, 2023 and Mar 13, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PATIENT¿S VISION HAD IMPROVED TO A DEGREE. THE MAIN ISSUE REPORTED WAS THAT EVERYTHING WAS ¿FUZZY,¿ AS IF THE PATIENT WAS ¿WEARING GLASSES THAT ARE SMEARED WITH SOMETHING THAT DID NOT GO AWAY AND WERE THERE 24 HOURS.¿ THE CONSUMER REPORTED THAT THE HALOS PREVENTED THE PATIENT FROM SEEING AT NIGHT, AND THE PATIENT COULD NO LONGER DRIVE AT NIGHT. THE CONSUMER ALSO REPORTED THAT THIS SITUATION CAUSED DEPRESSION AND ANXIETY BECAUSE THE PATIENT HAD BEEN EXTREMELY ACTIVE AND VACATIONED FREQUENTLY BUT COULD NOT DO THAT NOW.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 24597964 ↗
• InjuryJun 9, 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 POOR VISION AND NIGHT TIME DYSPHOTOPSIA . THE IOL WAS EXCHANGED FOR MONOFOCAL LENS MODEL 3 MONTHS AND 2 DAYS AFTER THE INITIAL IMPLANT PROCEDURE. CLINICAL REASON FOR EXPLANT WAS REPORTED AS DECREASED UNCORRECTED VISUAL ACUITY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 22167511 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SUSPECTED TOXIC ANTERIOR SEGMENT SYNDROME (TASS) WAS FOUND AFTER AN IOL WAS INSERTED. ON (B)(6) 2025 AT THE HOSPITAL APPOINTMENT, THE RIGHT ANTERIOR CHAMBER INFLAMMATION AND FORMATION OF FIBRIN AT THE BACK SIDE OF THE IOL WERE CONFIRMED. HOWEVER, NEITHER HYPOPYON NOR VITREOUS INFLAMMATION WERE OBSERVED. THE PATIENT DID NOT HAVE ANY PAIN, AND INFLAMMATORY CELLS ARE NOT SO BIG. SO, SINCE THESE WERE NOT THE FINDINGS TO SUSPECT BACTERIAL ENDOPHTHALMITIS POSITIVELY, POSTOPERATIVE INFLAMMATION OR TASS WERE SUSPECTED. THE PATIENT TREATED WITH STEROID EYE DROPS FREQUENTLY AND EXAMINED EVERY DAY AT THE HOSPITAL. IN THE MORNING ON (B)(6), THE ANTERIOR CHAMBER INFLAMMATION ALMOST DISAPPEARED. FROM THE PROGRESS, IT IS NOT IDENTIFIED WHETHER A STRONG POSTOPERATIVE INFLAMMATION OR TASS. THE PATIENT'S CONDITION WILL IMPROVE GETTING CONSERVATIVE MEDICAL TREATMENT. THE CURRENT PRESCRIPTION INCLUDED ANTIBIOTIC, STEROID AND ANTI-INFLAMMATORY MEDICATION.

  Patient problems: Inflammation; Posterior Capsule Opacification

  MAUDE report 21883200 ↗
• MalfunctionDec 5, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS SCRATCHED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 20855193 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED IT STATES THAT THE PATIENT'S CONDITION WAS GOOD FOLLOWING THE MONOFOCAL LENS REPLACEMENT.

  Patient problems: Discomfort; Visual Impairment

  MAUDE report 19970224 ↗
• InjuryJul 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISUAL ACUITY. CLINICAL REASON BEING MENTIONED AS 20/40 BEST CORRECTED VISUAL ACUITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 19806166 ↗
• InjuryMay 17, 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 WAS UNABLE TO TOLERATE HALOS AROUND LIGHTS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. 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: Halo

  MAUDE report 19339975 ↗
• InjuryMay 14, 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 WAS UNABLE TO TOLERATE HALOS AROUND LIGHTS. THE IOL WAS EXCHANGED FOR UNSPECIFIED MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.

  Patient problems: Halo

  MAUDE report 19310971 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION HAS BEEN RECEIVED THE UPON EXAMINATION OF EYE 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 18160856 ↗
• InjurySep 12, 2023Adverse 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 DYSPHOTOPSIA- SEVERE. LIGHT SENSITIVITY. CLINICAL REASON BEING DYSPHOTOPSIA & BLURRY VISION. THE IOL WAS EXPLANTED AND EXCHANGED FOR AN UNKNOWN ATIOL FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT LENS WAS EXCHANGED FOR A DIFFERENT MODEL COMPANY LENS, ALSO NEW INFORMATION STATES THAT THE LENS CREATED UNACCEPTABLE HALOS FOR THE PATIENT.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 17728427 ↗