Clareon™ CNA0T0 (REF CNA0T0.300)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: 8
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652396530), received between Dec 17, 2021 and Jun 26, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (2 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 Advance2
Inaccurate Delivery2
Device Contaminated During Manufacture or Shipping1
Device Contamination with Chemical or Other Material1
Device Difficult to Setup or Prepare1
Failure to Deliver1
Failure to Eject1

Patient problems

No Clinical Signs, Symptoms or Conditions5
Insufficient Information4

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 26, 2026Device Difficult to Setup or Prepare
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE TRAILING HAPTIC GOT STUCK BETWEEN PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25633054 ↗
MalfunctionOct 3, 2025Failure to Advance; Failure to Advance
A PHYSICIAN REPORTED THAT DURING SURGERY, LENS DID NOT COME OUT FROM THE INJECTOR. THE INTRAOCULAR LENS (IOL) WAS NOT INSERTED INTO A PATIENT'S EYE. THE SURGERY WAS COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE PLUNGER OF THE DEVICE WAS ADVANCED TO THE OUTSIDE OF THE NOZZLE, AND THE LENS HAD ALREADY COME OUT OF THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 23211482 ↗
InjuryJul 15, 2025Inaccurate Delivery; Inaccurate Delivery
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS BLOCKED WITHIN EDGES OF 2.4MM INCISION SO, THE SURGEON REQUIRED TO ENLARGE THE INCISION. HENCE THE LENS WAS EXPLANTED DURING INITIAL PROCEDURE. THE SURGERY WAS COMPLETED ON THE SAME DAY BY IMPLANTING ANOTHER UNSPECIFIED REPLACEMENT LENS WITH SAME DIOPTER. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THERE WAS NO CONSEQUENCES FOR PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506641 ↗
MalfunctionJun 6, 2025Inaccurate Delivery; Inaccurate Delivery
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; WHILE ADVANCING THE PLUNGER, IOL OVERSHOT FROM THE PAUSE LOCATION. THERE WAS NO INJURY TO PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22156931 ↗
MalfunctionApr 30, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN LOADER. THERE WAS PATIENT CONTACT. THERE WAS NO PATIENT IMPACT REPORTED. PROCEDURE COMPLETED THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934268 ↗
MalfunctionNov 14, 2022Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping; Device Contamination with Chemical or Other Material; Device Contaminated During Manufacture or Shipping
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) A PLASTIC FILAMENT CAME OUT TOGETHER WITH THE LENS, IT COULD BE REMOVED IN TIME SO IT WAS NOT PLACED INSIDE OF THE CAPSULAR BAG. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15794922 ↗
MalfunctionJun 28, 2022Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE, WHEN TRYING TO IMPLANT LENS IT DIDN¿T EXIT THE INJECTOR CORRECTLY AND WAS UNABLE TO BE IMPLANTED. IT TOUCHED THE PATIENT¿S EYE. A NEW LENS WAS USED AND SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 14840718 ↗
MalfunctionDec 17, 2021Failure to Eject; Failure to Eject
A NON HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE DELIVERY SYSTEM MISFIRED. THERE WAS POSSIBLE PATIENT CONTACT BUT NO PATIENT HARM. THE PROCEDURE WAS COMPLETED WITH NEW LENS . ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER, WHO REPORTED LENS WOULD NOT EXPEL FROM DEVICE. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13026595 ↗

Device details

UDI-DI	`00380652396530`
Brand	Clareon™
Model	CNA0T0
Catalog no.	CNA0T0.300
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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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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