Clareon™ CNA0T0 (REF CNA0T0.110)Recalls & reported problems

Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652393539), received between Mar 1, 2023 and Jul 8, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (4 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Failure to Advance4
Device Difficult to Setup or Prepare1
Failure to Deliver1
Failure to Eject1
Unintended Ejection1

Patient problems

Insufficient Information3
No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 8, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN DELIVERY SYSTEM, SO SURGEON REMOVED THE LENS FROM THE CARTRIDGE AND PLACED IT WITH A MANUAL INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22434657 ↗
MalfunctionMay 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE TRAILING HAPTIC STUCK IN INJECTION. THE PROCEDURE WAS COMPLETED WITH UNSPECIFIED LENS ON THE SAME DAY. THERE WAS A PATIENT CONTACT AND NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045745 ↗
MalfunctionOct 15, 2024Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PLUNGER DIDN¿T ENGAGE PROPERLY WITH THE LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 20450092 ↗
MalfunctionMay 31, 2023Failure to Advance; Failure to Eject; Failure to Advance; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE PLUNGER PASSED UNDER THE LENS THROUGH WHICH THE LENS DID NOT EXIT. SINCE THERE WAS NO REPLACEMENT LENS, PROCEEDED TO UNCOVER THE DEVICE AND REMOVED THE LENS AND LOAD IT INTO A CARTRIDGE. THE LENS WAS IN PERFECT CONDITION AND WAS IMPLANTED WITHOUT ANY ISSUES.
Patient problems: Insufficient Information
MAUDE report 17029417 ↗
MalfunctionMar 1, 2023Unintended Ejection; Failure to Advance; Unintended Ejection; Failure to Advance
AN INVENTORY MANAGEMENT SPECIALIST REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR FELT THAT THE INJECTOR WAS FAULTY AS LENS APPEARED TO ADVANCE TOO QUICKLY AND WAS NOT ABLE TO BE INSERTED INTO THE EYE. THERE WAS A PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED SAME DAY. THERE WAS NO PATIENT HARM AND PATIENT WAS NOT HOSPITALIZED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16458252 ↗

Device details

UDI-DI	`00380652393539`
Brand	Clareon™
Model	CNA0T0
Catalog no.	CNA0T0.110
Company	Alcon Laboratories, Inc.
Product code	MFK · Lens, multifocal intraocular
Class	Class 3
FDA submission	None listed
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 8, 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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All Lens, multifocal intraocular devices →

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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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