Clareon CCWET3 (UDI 00380652455343)Recalls & reported problems

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

All models of Clareon (1142)

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

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652455343), received between Aug 2, 2022 and Dec 26, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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

Break3
Scratched Material2
Defective Device1
Device Difficult to Setup or Prepare1

Patient problems

Insufficient Information4
No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 26, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS BROKEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23901035 ↗
MalfunctionJun 17, 2025Break; Break
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS SHEARED WHEN IT WAS ADVANCED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 22236047 ↗
MalfunctionApr 4, 2025Device Difficult to Setup or Prepare; Scratched Material; Device Difficult to Setup or Prepare; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SCRATCH ON LENS. THE LENS WAS REMOVED AND REPLACED WITH BACKUP LENS DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT IN SURGEON OPINION LOADING ERROR CAUSED THE EVENT. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21773954 ↗
MalfunctionJan 13, 2025Break; Break
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF HAPTIC BROKEN.
Patient problems: Insufficient Information
MAUDE report 21136566 ↗
MalfunctionJun 20, 2023Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE BLEMISH ON LENS WAS NOTICED AFTER INSERTION. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, SMALL CIRCULAR SCRATCH LIKE APPEARANCE WAS SEEN ON THE LENS IMMEDIATELY AFTER INSERTION. NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17162242 ↗
MalfunctionAug 2, 2022Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE LENS WAS DEFECTIVE. THE LENS WAS NOT USED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION AND NO NEW INFORMATION WAS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15146077 ↗

Device details

UDI-DI	`00380652455343`
Brand	Clareon
Model	CCWET3
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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