Clareon™ CNA0T0 (REF CNA0T0.260)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
Quick summary
This Alcon Clareon CNA0T0 is a foldable artificial eye lens delivered by a pre-loaded automated injector during cataract surgery. The 42 reports mostly describe the lens or injector failing during surgery — the lens sticking in the injector, not deploying or advancing, or haptics bent or folded so the surgeon could not insert it. No deaths and one injury were reported; most other reports note no patient harm. No recalls name this device, and the report count was 12 in both the past 12 months and the 12 before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 00380652396455), received between Nov 11, 2021 and Sep 22, 2026 — classified as 1 injury, 42 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (8 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
Most reported problems
Device problems
- Device Difficult to Setup or Prepare8
- Failure to Advance7
- Failure to Deliver7
- Failure to Eject7
- Device Damaged by Another Device4
- Defective Device2
- Difficult to Advance2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Insufficient Information23
- No Clinical Signs, Symptoms or Conditions19
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857583 ↗MalfunctionSep 15, 2026Particulates; Device Difficult to Setup or Prepare
A healthcare professional reported that the during surgery it was observed that the cartridge was in different color (pink). When it was tried to inject viscoelastic with this pink color, in the end the lens could not come out. An unexpected material in the eye was also observed. There was a patient contact. The surgery was completed with a company IOL on the same day.
Patient problems: Insufficient Information
MAUDE report 50775818 ↗MalfunctionJul 27, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50017411 ↗MalfunctionJun 15, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25500791 ↗MalfunctionMay 12, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC WAS FOLDED WRONG. THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT THAT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25150371 ↗MalfunctionApr 20, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD AS WASTED DAMAGED FROM MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24925858 ↗MalfunctionApr 3, 2026Failure to Advance; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS ADVANCED AND GOT STUCK IN THE NOZZLE WHEN THE IOL WAS BEING LOADED, DISTAL PORTION OF THE APERTURE WAS BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777306 ↗MalfunctionMar 10, 2026Failure to Deliver
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WOULD NOT DEPLOY.
Patient problems: Insufficient Information
MAUDE report 24559979 ↗MalfunctionFeb 27, 2026Inaccurate Delivery
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT ISSUE WAS DUE TO PROVIDER ERROR.
Patient problems: Insufficient Information
MAUDE report 24470516 ↗MalfunctionFeb 20, 2026Device Damaged by Another Device
A NON HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF THE LENS HAD A BROKEN HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24402446 ↗MalfunctionDec 24, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTICS WERE STUCK, AND THE LENS WOULD NOT DEPLOY. THE SURGERY WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23888206 ↗MalfunctionDec 4, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED VIA MEDWATCH FORM THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DID NOT DEPLOY CORRECTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23716504 ↗MalfunctionNov 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY DAMAGE ON THE HAPTIC WAS NOTICED AND THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23631855 ↗MalfunctionAug 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING LOADING IT WAS NOTED THAT THE TRAILING HAPTIC STUCK ON DEPLOY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22828580 ↗MalfunctionAug 7, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE DELIVERY SYSTEM DID NOT ADVANCE/LOAD/INJECT AS EXPECTED. THERE WAS NO ISSUES WITH PATIENT AND A BACK UP LENS WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, IT DID NOT DEPLOY CORRECTLY AND THERE WAS PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 22739997 ↗MalfunctionMay 13, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHARMACIST REPORTED WITH A DESCRIPTION OF DESTRUCTION IN THE PRELOADED DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22010621 ↗MalfunctionApr 30, 2025Failure to Deliver; Failure to Deliver
NON-HEALTHCARE PROFESSIONAL DURING SURGERY REPORTED THAT THE LENS STUCK IN THE CARTRIDGE. PROCEDURE COMPLETED THE SAME DAY AND THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21933636 ↗MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THERE WAS AN IMPLANT PLACEMENT FAILURE. PATIENT IMPACT UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21863722 ↗MalfunctionMar 11, 2025Break; Device Difficult to Setup or Prepare; Break; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT THE PRELOADED INTRAOCULAR LENS INJECTOR WAS DEFECT. THE SURGERY WAS COMPLETED WITH THE BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT HAPTIC WAS BROKEN WHEN TRYING TO INJECT THE IMPLANT IN THE PATIENT'S EYE. THERE WAS A PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 21572073 ↗MalfunctionMar 3, 2025Scratched Material; Scratched Material
NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS SCRATCHED. THERE WAS NO PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21506386 ↗MalfunctionJan 27, 2025Failure to Advance; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, AN IMPLANT PLACEMENT FAILURE HAD OCCURRED AND THE IMPACT ON THE PATIENT WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21239382 ↗MalfunctionDec 10, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF AFTER LOADING THE INTRAOCULAR LENS THE SURGEON ENGAGED THE BUTTON, AND THE LENS CAME OUT OF THE TIP OF THE CARTRIDGE BEFORE GETTING IT INSIDE THE EYE. THERE WAS PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20894037 ↗InjuryNov 14, 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, ON THE LEFT EYE, IN THE PRESENCE OF A STRONG POINT OF LIGHT, STARTED TO SEE A LUMINOUS BEAM REFRACTED IN THE COLORS OF THE RAINBOW, SIMILAR TO A COMPASS NEEDLE (THIN AT THE TIPS AND THE WIDTH OF THE LUMINOUS POINT IN THE CENTER) AT THE CLOCKWISE POSITION OF 3H:50M. THE FIRST TIME THE PATIENT DROVE AT NIGHT IT WAS TERRIBLE, BECAUSE THE LIGHT OF EACH POLE OR SIGN PRESENTED THIS LUMINOUS BEAM. EVEN IN THE RESTAURANT, EVERY POINT OF LIGHT PRESENTED THIS BEAM. THE PATIENT THOUGHT IT COULD BE A PROBLEM WITH THE SURGERY. THIS WAS VERY DISTURBING AND THE PATIENT NEVER DROVE AT NIGHT AGAIN. AFTER SURGERY OF THE LEFT EYE, UNDER STRONG LIGHT SUCH AS THE SUN, OR EVEN IN A WELL-LIT INTERNAL ENVIRONMENT, THE LUMINOSITY OF WHAT WAS SEEN WAS MUCH HIGHER THAN BEFORE WITH THE LENS. THE PATIENT STARTED TO SEE THE EXCESSIVELY WHITE, BURSTING THE LIGHT COLOR AND TENDING TO BLUISH. IT WAS AS IF THE COLOR TEMPERATURE OF THE WHITE I SAW WAS CLOSE TO 5,500 DEGREES KELVIN. THE PATIENT EVEN THOUGHT ABOUT SUGGESTING TO COMPANY THAT A FILTER BE PLACED ON THE LENSES, LOWERING AT LEAST 100 DEGREES KELVIN IN WHAT YO
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 20680705 ↗MalfunctionNov 12, 2024Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20666131 ↗MalfunctionNov 8, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS DID NOT UNLOAD CORRECTLY. THERE WAS A PATIENT CONTACT. PROCEDURE IS COMPLETED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20641956 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.