Clareon™ CNA0T0 (REF CNA0T0.125)Recalls & reported problems

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

All models of Clareon (1142)

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

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652393560), received between Apr 23, 2023 and Sep 26, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Failure to Eject” (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

Failure to Eject3
Adverse Event Without Identified Device or Use Problem1
Defective Device1
Material Deformation1
Material Discolored1

Patient problems

Insufficient Information4
No Clinical Signs, Symptoms or Conditions2
Visual Impairment1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 26, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906822 ↗
InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POOR NEAR VISUAL ACUITY AND MISSED NEAR TARGET. THE LENS WAS EXPLANTED AND EXCHANGED WITH MONOFOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION RECEIVED.
Patient problems: Visual Impairment
MAUDE report 25044399 ↗
MalfunctionNov 28, 2024Failure to Eject; Failure to Eject
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY LENS WAS STUCK AND WOULD NOT EJECT OUT OF DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20805101 ↗
MalfunctionMay 6, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED A DEFECTIVE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19247327 ↗
MalfunctionApr 18, 2024Material Discolored; Material Discolored
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED STAIN ON IOLS SURFACE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19134769 ↗
MalfunctionNov 24, 2023Failure to Eject; Failure to Eject
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PLUNGER PASSED OVER THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18204303 ↗
MalfunctionApr 23, 2023Failure to Eject; Failure to Eject
A NURSE REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION WHEN PRESSED THE BUTTON, THE IOL CONTINUOUSLY WENT OUT OF THE DEVICE AND IT DIDN¿T STOP. THE LENS WAS IMPLANTED MANUALLY WITH A CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 16792859 ↗

Device details

UDI-DI	`00380652393560`
Brand	Clareon™
Model	CNA0T0
Catalog no.	CNA0T0.125
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 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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