Clareon™ CNA0T0 (REF CNA0T0.180)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 Aspheric Hydrophobic Acrylic IOL is a presbyopia-correcting cataract lens delivered through a pre-loaded automated cartridge. The 42 reports mostly describe delivery problems during surgery: the lens failing to eject or advance, haptics bending, twisting or jamming inside the cartridge, and difficulty preparing the device. Reports include 1 injury and no deaths, with one case of eye infection after implantation. No recalls name this device.
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
- 44
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00380652393676), received between Aug 26, 2021 and Sep 24, 2026 — classified as 1 injury, 43 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 Eject8
- Failure to Advance7
- Material Twisted/Bent6
- Product Quality Problem4
- Defective Device3
- Failure to Deliver3
- Defective Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions23
- Insufficient Information19
- Eye Infections1
- Eye Pain1
- Fibrosis1
Recent adverse event reports
The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Device Difficult to Setup or Prepare; Failure to Advance; Device Damaged by Another Device
A surgeon reported that during a cataract surgery and intraocular lens (IOL) implant procedure, after the automatic plunger advancement was activated, the plunger moved over the lens, and movement within the cartridge resulted in the haptic being torn off and the cartridge rupturing during insertion of the lens into the eye. The lens had to be removed, and another lens was implanted. The originally scheduled surgery was completed on the same day with no harm to the patient.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 50884054 ↗MalfunctionSep 24, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been requested and received by stating there was no visual impact to the patient.There are multiple medical reports associated with same event. This file is 25 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883845 ↗MalfunctionSep 17, 2026Material Twisted/Bent
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, the haptic came out bent. There was no patient contact.Additional information has been requested and received stating that procedure was completed on same day and there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50799228 ↗MalfunctionAug 13, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50237145 ↗MalfunctionJul 27, 2026Material Twisted/Bent
Patient problems: Insufficient Information
MAUDE report 50017322 ↗MalfunctionJul 7, 2026Device Difficult to Setup or Prepare; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DAMAGED OR JAMMED IN THE DELIVERY SYSTEM. IT WAS HANGING WITHIN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER UNSPECIFIED LENS WITHOUT CAUSING HARM TO THE PATIENT. THERE WAS NO PATIENT CONTACT. 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 25733865 ↗MalfunctionJun 3, 2026Product Quality Problem
A OTHER HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25373829 ↗InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT THREE DAYS AFTER THE IMPLANTATION OF THE INTRAOCULAR LENS (IOL), THE PATIENT DEVELOPED FULMINANT PANOPTHALMITIS. ADDITIONAL INFORMATION INDICATED THAT THE EVENT INVOLVED THE PATIENT¿S LEFT EYE. THE PATIENT CAME UP WITH EYE PAIN ON THIRD DAY AND WAS SHIFTED TO ANOTHER HOSPITAL WHERE SHE WAS GIVEN INTRAVITREAL TREATMENT, BUT THEY WERE NOT ABLE TO SAVE THE EYE.
Patient problems: Eye Infections; Eye Pain
MAUDE report 24831868 ↗MalfunctionApr 7, 2026Material Twisted/Bent
A NON HEALTHCARE PROFESSIONAL REPORTED THAT THE HAPTIC WAS BENT STRAIGHT UP AND WOULD NOT GO INTO PLACE. SURGERY WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24801965 ↗MalfunctionMar 23, 2026Break; Failure to Advance
A PHYSICIAN REPORTED THAT DURING PREPARATION OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE COMPANY VISCOELASTIC SOLUTION WAS INSERTED THROUGH THE PORT FOR THE INTRODUCTION OF THE VISCOELASTIC SOLUTION, THE LOCKING MECHANISM WAS REMOVED, AND THE SPEED CONTROL LEVER WAS ACTIVATED. AFTER WHICH THE PISTON WENT PAST THE LENS AND THE LENS WAS CLAMPED WITH THE SEPARATION OF PART OF THE HAPTIC ELEMENT. 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 24663522 ↗MalfunctionMar 23, 2026Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, HAPTIC WAS BENT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NEW PRODUCT WITHOUT HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24661175 ↗MalfunctionFeb 17, 2026Material Deformation
A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SUBSURFACE NANO-GLISTENINGS WITH ANTERIOR IOL OPACIFICATION. IN THE SURGEON'S OPINION PRODUCT WAS CAUSE OR CONTRIBUTE TO THE EVENT AND IN SURGEON'S PROGNOSIS MOST LIKELY WOULD NOT AFFECT VISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: Fibrosis
MAUDE report 24365395 ↗MalfunctionJan 16, 2026Product Quality Problem
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SMUDGE ON THE IOL WAS OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24093816 ↗MalfunctionJan 12, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WOULD NOT DISCHARGE, THE PLUNGER SLIDE UNDER LENS WITH PATIENT CONTACT AND NO PATIENT HARM. THE LENS REMAINED IN THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24049988 ↗MalfunctionJan 9, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS STUCK IN DELIVERY SYSTEM AND LENS WOULD NOT ADVANCE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24022372 ↗MalfunctionJan 8, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF LENS ENDED UP CROOKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24003690 ↗MalfunctionNov 6, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS WENT HALFWAY IN THE EYE AND IT STOPPED ADVANCING. NEW LENS WAS REQUESTED, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT INJURY NOR MEDICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23486320 ↗MalfunctionOct 31, 2025Component Missing; Component Missing
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF LOADING THE SURGEON COULD NOT SEE THE HAPTIC. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23438167 ↗MalfunctionAug 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED A DEFECTIVE LENS. IT WAS REPORTED AS WASTED VIA A REPLY CARD. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 22726992 ↗MalfunctionAug 5, 2025Failure to Fold; Failure to Fold
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL FAILED TO LOAD IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22717150 ↗MalfunctionJun 24, 2025Material Twisted/Bent; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS FOUND TO BE BENT OR CRIMPED. THERE WAS PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22321228 ↗MalfunctionApr 24, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHARMACIST REPORTED WITH A DESCRIPTION OF IMPLANT INCORRECTLY REMOVED FROM INJECTOR. NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898217 ↗MalfunctionApr 4, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE VISCOELASTIC WAS PLACED IN THE INJECTOR CHAMBER AND THE SAFETY WAS REMOVED. THE DOCTOR PERFORMED THE MANEUVER OF PRESSING IT SO THAT THE INTERNAL PLUNGER DISPLACES THE LENS AND THE LENS DID NOT MOVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE WAS NO DAMAGE OR INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21775302 ↗MalfunctionMar 20, 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, THE TRAILING HAPTIC WAS STUCK DURING SURGERY. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21653541 ↗MalfunctionFeb 19, 2025Failure to Advance; Failure to Advance
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER WENT OVER OR UNDER THE DEVICE, NOT ADVANCING THE LENS FAR ENOUGH TO EJECT. ADDITIONAL INFORMATION HAS BEEN RECEIVED, STATING THAT, THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, ALL THE FOUR LENSES WERE USED ON THE SAME PATIENT.
Patient problems: Insufficient Information
MAUDE report 21411167 ↗
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.