Clareon CNW0T6 (UDI 00380652411219)Recalls & reported problems

Alcon Laboratories, Inc. · CLAREON BLF 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: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652411219), received between Feb 11, 2022 and Apr 27, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Crack” (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 Problem2
Crack1
Scratched Material1

Patient problems

Blurred Vision1
Corneal Scar1
Diplopia/Double Vision1
Insufficient Information1
No Clinical Signs, Symptoms or Conditions1
Retinal Degeneration1
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.

MalfunctionApr 27, 2026Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE LENS WAS REMOVED AND REPLACED WITH REPLACEMENT LENS DURING THE INITIAL PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25000929 ↗
InjuryDec 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PATIENT EXPERIENCED INTOLERANT MONOVISION WITH EPI RETINAL MEMBRANE (ERM) 01. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS OF SAME COMPANY IN A SECONDARY PROCEDURE.
Patient problems: Blurred Vision; Retinal Degeneration
MAUDE report 23896903 ↗
InjuryMay 8, 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 DOUBLE VISION, PROBLEM WITH BALANCE & DEPTH PERCEPTION AND EXCISION CORNEAL SCAR . CLINICAL REASON IS PATIENT STILL HAD 4.5 DIOPTERS OF CYLINDER POST OPERATIVE. THE IOL WAS EXCHANGED FOR ADVANCED TECHNOLOGY INTRAOCULAR LENSES (ATIOL) MODEL 2 WEEKS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Corneal Scar; Diplopia/Double Vision; Visual Disturbances; Visual Impairment
MAUDE report 19270217 ↗
MalfunctionFeb 11, 2022Crack; Crack
AN OPHTHALMIC SURGEON REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE OPTIC CRACKED. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT. THE SAMPLE IS NOT AVAILABLE AS IT STILL REMAINS IN THE PATIENT'S EYE. IN SURGEONS OPINION IN THE VIDEO THE CRACK SEEMED LIKE LUBRICANT OF THE CARTRIDGE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 13513485 ↗

Device details

UDI-DI	`00380652411219`
Brand	Clareon
Model	CNW0T6
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	Jul 21, 2022

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 13, 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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