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Clareon CNWTT0 (UDI 00380652407946)Recalls & reported problems

Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652407946), received between Apr 3, 2024 and Feb 10, 2025 — 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 1 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 1 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Blurred Vision1
  • Visual Impairment1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED POOR VISION QUALITY. THE LENS WAS EXCHANGED WITH AN UNKNOWN MONOFOCAL IOL AFTER THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS POOR VISION QUALITY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Visual Impairment

    MAUDE report 21343465 ↗
  • InjuryApr 3, 2024Adverse 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 BLURRY. THE IOL WAS EXCHANGED FOR OTHER COMPANY ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) LENS MODEL APPROXIMATELY 7 MONTHS FOLLOWING THE INITIAL IMPLANT PROCEDURE. THE CLINICAL REASON FOR EXCHANGE WAS FAILURE TO ADAPT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Patient problems: Blurred Vision

    MAUDE report 19031427 ↗

Other LENS, INTRAOCULAR, TORIC OPTICS devices

All LENS, INTRAOCULAR, TORIC OPTICS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.