Clareon™ CNA0T0 (REF CNA0T0.245)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 presbyopia-correcting artificial lens implanted during cataract surgery, delivered through a preloaded injector. The 66 reports mostly describe delivery problems: the injector failing to advance or eject the lens, the lens sticking folded or partly inserted, and damaged packaging or labeling. Fourteen injuries and no deaths were reported, including blurred or impaired vision and corneal edema. There are no recalls naming 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
- 68
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00380652393805), received between Jan 5, 2022 and Sep 25, 2026 — classified as 14 injuries, 54 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (16 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 Markings/Labelling Problem16
- Failure to Eject10
- Device Damaged by Another Device9
- Failure to Advance8
- Device Difficult to Setup or Prepare6
- Defective Component4
- Defective Device4
- Failure to Deliver4
Patient problems
- Insufficient Information32
- No Clinical Signs, Symptoms or Conditions21
- Visual Impairment15
- Corneal Edema3
- Blurred Vision1
- Eye Injury1
- Fibrosis1
Recent adverse event reports
The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been received and stated that there has been no visual impact to patient.There are multiple medical reports associated with same event. This file is 18 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894670 ↗MalfunctionSep 22, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.There are two medical reports associated with this patient. This file belongs to left eye.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 13 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853457 ↗MalfunctionSep 18, 2026Material Twisted/Bent
A health care professional reported that during the intraocular lens (IOL) implant procedure lens found to have straight and slightly curved leading haptic. However surgeon was still able to successfully implant the IOL.
Patient problems: Insufficient Information
MAUDE report 50812987 ↗MalfunctionJul 13, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25795550 ↗MalfunctionJun 4, 2026Inaccurate Delivery
A PHARMACIST REPORTED WITH A DESCRIPTION OF EDGE-EXTERIORIZATION. THE IMPLANT WAS PARTIALLY INSERTED AND HAD TO BE REMOVED IN ORDER TO PLACE THE UNSPECIFIED BACKUP IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25393407 ↗MalfunctionApr 15, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT FUNCTION IN THE INJECTOR. THE LENS REMAINED BELOW THE PISTON THAT PUSHES THE INTRAOCULAR LENS. THE TIP OF THE PRELOADED DEVICE HAD CONTACT WITH THE PATIENT. THE PATIENT EXPERIENCED INCISIONAL EDEMA. THE PATIENT WAS NOT HOSPITALIZED, NO TREATMENT WAS GIVEN, AND THE PATIENT RECOVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Corneal Edema
MAUDE report 24887839 ↗MalfunctionApr 6, 2026Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT THE PLUNGER DOES NOT MOVE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24796052 ↗MalfunctionApr 6, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY DURING IMPLANTATION PROCEDURE LENS STUCK IN FOLDED POSITION. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED ON THE SAME DAY USING ANOTHER LENS WITHOUT ANY PATIENT HARM. IN HE SURGEON'S PROGNOSIS PATIENT CONDITION WAS GOOD AND ISSUE WAS RESOLVED. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24787939 ↗MalfunctionApr 1, 2026Failure to Deliver
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT THE LENS WOULD NOT ADVANCE IN THE LOADER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24755831 ↗MalfunctionMar 30, 2026Defective Component
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE NOZZLE WAS CRUSHED WHEN THEY OPENED A COMPANY PRELOAD DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24727771 ↗MalfunctionMar 9, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, THE TRAILING HAPTIC FOLDED WRONG. PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND THE FILE WAS UPDATED ACCORDINGLY.
Patient problems: Insufficient Information
MAUDE report 24546538 ↗MalfunctionFeb 13, 2026Inaccurate Delivery
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL PUSHER MISPOSITIONED THE LENS INTO THE NARROW PART OF THE CARTRIDGE, DUE TO CONTACT BETWEEN THE IOL PUSHER AND THE OPTICAL PART OF THE LENS AND RESULTED IN DAMAGE TO THE OPTICS. 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 24333370 ↗MalfunctionFeb 5, 2026Device Difficult to Setup or Prepare; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEVICE MALFUNCTIONED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24268801 ↗MalfunctionJan 17, 2026Failure to Advance
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS DID NOT ADVANCE AS THE PLUNGER OVERRODE THE LENS. THERE WAS NO PATIENT CONTACT. PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24105479 ↗MalfunctionDec 24, 2025Material Twisted/Bent; Material Twisted/Bent
THE EVENT REPORT FOR THIS FILE WAS RECEIVED FROM THE FDA STATING THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT LENS WAS TWISTED WHILE BEING DEPLOYED FOR PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23887703 ↗MalfunctionDec 2, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION WAS RECEIVED AND STATED, LENS UNFOLDED BADLY WHEN THE SURGEON MADE IT MOVE FORWARD, ITS SMALL LEG CAME FIRST. AS THE PATIENT HAD A FRAGILE EYE, SURGEON PREFERRED TO CHANGE THE LENS TO AVOID FURTHER MANIPULATION IN THE PATIENT EYE.
Patient problems: Insufficient Information
MAUDE report 23692267 ↗MalfunctionNov 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR IMPLANTATION SURGERY, THERE WAS DIFFICULTIES WITH INJECTION AS THE IMPLANT WAS TOO RIGID. HENCE THE BACK LENS WAS IMPLANTED AND THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 23486823 ↗MalfunctionAug 21, 2025Failure to Fold; Device Difficult to Setup or Prepare; Failure to Fold; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS HAPTIC FAILURE WHILE LOADING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22858462 ↗MalfunctionJul 29, 2025Device Difficult to Setup or Prepare; Material Deformation; Device Difficult to Setup or Prepare; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC WAS NOT FOLDED PROPERLY AND LENS ADVANCED WITH DIFFICULTY. THE LENS WAS EXAMINED UNDER A MICROSCOPE AND WAS SEEN TO BE DAMAGED. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT, THE DEVICE TIP DIDN'T COME IN CONTACT WITH THE PATIENT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22643760 ↗MalfunctionJul 11, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING INSERTION OF THE IOL INTO POSTERIOR BAG, NOTED CRACK IN THE HAPTIC JUNCTION WHEN THE LENS OPENED IN THE BAG. THE LENS WAS IMPLANTED AND REPLACED WITH ANOTHER LENS IN THE INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22479248 ↗MalfunctionJun 13, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED AN INJECTION PROBLEM. THE PATIENT IMPACT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203200 ↗MalfunctionMay 20, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT, THE SURGEON REPORTED THAT DURING THE INTRODUCTION OF THE VISCOELASTIC INTO THE SYSTEM, HE NOTICED THAT THE LENS WAS NOT STRAIGHTENED UNIFORMLY IN THE CARTRIDGE AND WAS NOT BENT EVENLY. THEREFORE, HE DECIDED TO REPLACE THE LENS. THERE WAS NO PATIENT INVOLVEMENT. CURRENT PATIENT CONDITION WAS REPORTED AS, NO COMPLICATIONS, CONDITION WAS STABLE WITH PLANNED REFRACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22052655 ↗MalfunctionMar 28, 2025Device Difficult to Setup or Prepare; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE HAPTIC DEFECT WAS DETECTED AFTER IMPLANTING THE LENS. THE LENS WAS EXPLANTED AND REPLACED WITH SIMILAR LENS DURING INITIAL PROCEDURE WITHOUT ANY PATIENT HARM. CURRENT CONDITION OF THE PATIENT WAS SATISFACTORY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT ONE HAPTIC WAS MISSING AFTER IMPLANTATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21718483 ↗MalfunctionMar 27, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS DID NOT UNFOLD. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21716026 ↗MalfunctionJan 22, 2025Failure to Eject; Failure to Eject
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS FAILED TO COME OUT FROM INJECTOR. THE SURGERY WAS COMPLETED ON THE SAME DAY USING AN UNSPECIFIED BACK UP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21205778 ↗
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.