Clareon CNWET5 (UDI 00380652467186)Recalls & reported problems

Alcon Laboratories, Inc. · Clareon Vivity Toric · Class 3 · Implant

All models of Clareon (1142)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652467186), received between Oct 17, 2024 and Oct 29, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Break1
Device Difficult to Setup or Prepare1
Material Deformation1
Material Twisted/Bent1

Patient problems

Insufficient Information2
Headache1
No Clinical Signs, Symptoms or Conditions1
Visual Disturbances1
Visual Impairment1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 29, 2025Break; Break
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED ONE OF THE HAPTICS WAS NOT ATTACHED PROPERLY. SURGEON DECIDED TO EXPLANT THE IOL DURING WHICH THE HAPTIC CAME OFF AS THE IOL WAS BEING ROTATED OUT OF THE BAG IMMEDIATELY EXPLANTED AND BACKUP UTILIZED DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410636 ↗
MalfunctionApr 17, 2025Material Deformation; Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DAMAGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21858079 ↗
MalfunctionApr 17, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED BEFORE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS SOME DIFFICULTY LOADING IN THE LENS. THE HAPTIC ARMS WERE UNFOLDING AND THERE WAS SOME RESISTANCE. LENS DID NOT LOOK DAMAGED BUT SURGEON DID NOT FEEL COMFORTABLE LOADING IT AGAIN AND USED THE BACK-UP LENS. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21857507 ↗
InjuryOct 17, 2024Adverse 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, HEADACHE, GLARE, DISTORTIONS. CLINICAL REASON WAS MENTIONED AS OPTICAL ABERRATION INDUCED BY EXTENDED DEPTH OF FOCUS AND DYSPHOTOPSIA. THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE.
Patient problems: Headache; Visual Disturbances; Visual Impairment
MAUDE report 20468942 ↗

Device details

UDI-DI	`00380652467186`
Brand	Clareon
Model	CNWET5
Company	Alcon Laboratories, Inc.
Product code	HQL · intraocular lens
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	—
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 17, 2021

Device type (GMDN): Posterior-chamber intraocular lens, pseudophakic

An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.

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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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