Clareon™ CNA0T0 (REF CNA0T0.190)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon CNA0T0 is a foldable intraocular lens (a replacement lens implanted during cataract surgery) loaded in an automated pre-loaded delivery system. Most of the 72 reports describe loading and delivery problems during surgery — the lens or its plunger not releasing properly, the haptics bent or curled, the lens not advancing through the injector, or the lens breaking as it is pushed out. Three reports mention patient injury, and no deaths were reported. 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
- 75
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00380652393690), received between Aug 23, 2021 and Sep 25, 2026 — classified as 3 injuries, 72 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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 Difficult to Setup or Prepare16
- Failure to Eject12
- Failure to Advance9
- Failure to Deliver7
- Defective Device5
- Device Damaged by Another Device4
- Inaccurate Delivery4
- Material Twisted/Bent4
Patient problems
- Insufficient Information38
- No Clinical Signs, Symptoms or Conditions37
- Blurred Vision1
- Capsular Bag Tear1
- Intraocular Pressure Increased1
- Irritability1
- Uveitis1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 75 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 28 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897763 ↗MalfunctionSep 25, 2026Inaccurate Delivery
A nurse reported that during an intraocular lens (IOL) implant procedure, upon implantation, the lens became stuck in the wound. The lens was explanted and replaced with the same model company lens during the initial procedure. The lens was discarded.Additional information was requested and received stating that, in the surgeon¿s opinion, during implantation of this lens, patient head movement resulted in the lens becoming stuck in the incision. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894263 ↗MalfunctionSep 23, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information was received stating that there has been no visual impact to patient at all and the lens remained in the eye.There are multiple medical reports associated with same event. This file is 2 of 29.
Patient problems: Insufficient Information
MAUDE report 50867412 ↗MalfunctionAug 13, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during intraocular implantation procedure at the time of loading, trailing haptic was folded wrong. The tip of the pre-loaded device was not in contact with the patient. The procedure was completed on the same day. 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 50232318 ↗MalfunctionMay 28, 2026Failure to Deliver
A PHYSICIAN REPORTED THAT DURING THE CATARACT WITH INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IMPLANT COULD NOT BE RELEASED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25313821 ↗MalfunctionMay 15, 2026Material Deformation
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED A GLISTENING IN THE IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25194720 ↗MalfunctionMay 12, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC CURL WAS OBSERVED. THE LENS WAS REMOVED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25146765 ↗MalfunctionApr 29, 2026Dent in Material
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT THE SURGERY COMPLETED SAME DAY WITH REPLACEMENT LENS. THERE WAS NO PATIENT HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25028045 ↗MalfunctionApr 7, 2026Failure to Advance; Device Damaged by Another Device
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF THE LENS PREPARATION FOR IMPLANTATION IT WAS NOTED THAT THE DEVICE PLUNGER PASSED THROUGH THE SIDE OF THE LENS, WHICH CAUSED THE LENS TO BEND INCORRECTLY AND IT WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY IMPACT TO THE PATIENT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE PATIENT CONDITION WAS RESOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801960 ↗MalfunctionApr 2, 2026Failure to Fold
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS FAILED TO TACK DURING SURGERY. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24762133 ↗MalfunctionMar 5, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24516252 ↗MalfunctionFeb 27, 2026Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE. THERE WAS PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24466505 ↗MalfunctionFeb 12, 2026Particulates; Scratched Material
ADDITIONAL INFORMATION RECEIVED ON 16-MAR-2026, THERE WERE NO DEBRIS ON THE LENS, ONLY SCRATCH WAS OBSERVED ON THE LENS.
Patient problems: Insufficient Information
MAUDE report 24322545 ↗MalfunctionFeb 12, 2026Device Difficult to Setup or Prepare; Inaccurate Delivery
A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED UNSPECIFIED ISSUE WITH THE LENS DURING PLACEMENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24321542 ↗MalfunctionFeb 5, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 24269287 ↗MalfunctionJan 30, 2026Failure to Deliver; Inaccurate Delivery
A PHARMACIST REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THERE WAS PLACEMENT FAILURE - THE IMPLANT GOT STUCK IN THE INJECTOR, THEREFORE, IT WAS POORLY INSERTED AND WAS NOT FULLY RELEASED INTO THE EYE. THE SAMPLE IS NOT AVAILABLE FOR RETURN AS IT WAS DESTROYED ON THE SAME DAY OF SURGERY. NO FURTHER INFORMATION EXPECTED AS REPORTER UNWILLING TO PROVIDE ADDITIONAL INFORMATION.
Patient problems: Insufficient Information
MAUDE report 24219296 ↗MalfunctionJan 12, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24043903 ↗MalfunctionJan 8, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC DAMAGED WHILE EJECTING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24004359 ↗MalfunctionDec 31, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LOCKED LENS AT THE TIME OF IMPLANTATION DOES NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23932625 ↗MalfunctionDec 30, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23920822 ↗MalfunctionDec 29, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHOOTING DEFECT PHENOMENON OCCURRED.
Patient problems: Insufficient Information
MAUDE report 23906481 ↗MalfunctionDec 28, 2025Failure to Fold; Failure to Fold
A NURSE REPORTED THAT DURING SURGERY, THEY NOTICED THAT LENS DID NOT LOAD PROPERLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE THREE FILES ASSOCIATED WITH THIS REPORT. THIS IS 3 OF 3.
Patient problems: Insufficient Information
MAUDE report 23903327 ↗MalfunctionDec 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23788955 ↗MalfunctionDec 8, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL HAPTIC WAS FOUND TO BE TORN. THE REPORTER CONFIRMED THAT THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT DURING THE ATTEMPT. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING THAT THE INJECTOR WENT OVER THE LENS AND TORE THE HAPTIC WITH PATIENT CONTACT. IN THE SURGEON'S OPINION, THE HAPTIC WAS STUCK UNDERNEATH THE PLUNGER AND WAS SHEARED WHEN IMPLANTING. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23744934 ↗MalfunctionNov 25, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, FAULTY HAPTIC.
Patient problems: Insufficient Information
MAUDE report 23644665 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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