Clareon™ CNWTT4 (UDI 00380652468831)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652468831), received between Jun 2, 2022 and May 20, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Contamination with Chemical or Other Material1
Patient problems
- Insufficient Information1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 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'S VISION WORSENED AFTER THE EIGHTH DAY. IT WAS STATED THAT THE VISION WAS DIM, BLURRY, AND MESSY; LETTERS APPEARED SHADED AND OVERLAPPED. IT WAS ALSO REPORTED THAT, IMMEDIATELY AFTER THE INSERTION, THE PATIENT HAD EXPERIENCED GLARE DURING BOTH DAY AND NIGHT, WHICH HAD GOTTEN WORSE OVER TIME. THE PATIENT'S SYMPTOMS INCLUDED GLARE, HALO, AND A RING PHENOMENON. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Disturbances; Visual Impairment
MAUDE report 22051795 ↗MalfunctionJun 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE MARK WHICH SEEMED TO BE EITHER A WHITE GLUE-LIKE FOREIGN MATERIAL OR A DAMAGE WAS FOUND ON THE HAPTIC AFTER IMPLANTING. IT WAS NOT ABLE TO BE REMOVED ALTHOUGH REMOVAL THROUGH IRRIGATION AND ASPIRATION WAS ATTEMPTED. THE SURGERY WAS COMPLETED BY EXPLANTING THE IOL AND IMPLANTING THE BACKUP LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 14572800 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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