Clareon™ CNA0T0 (REF CNA0T0.220)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 intraocular lens has 144 FDA adverse event reports, with no deaths and 6 injuries. Many describe the lens being hard to set up, the plunger failing to advance or push the lens out, and lenses being damaged or scratched. Many reports include no patient details. 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
- 144
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 144 adverse event reports that list this exact device (DI 00380652393751), received between Aug 26, 2021 and Sep 29, 2026 — classified as 6 injuries, 138 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (31 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 Prepare31
- Failure to Advance21
- Failure to Deliver21
- Failure to Eject21
- Device Damaged by Another Device15
- Defective Device10
- Material Twisted/Bent10
- Failure to Prime6
Patient problems
- Insufficient Information83
- No Clinical Signs, Symptoms or Conditions58
- Visual Disturbances2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Capsular Bag Tear1
- Corneal Perforation1
- Excessive Tear Production1
Recent adverse event reports
The 25 most recent of 144 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Deliver
A nonhealth care professional reported that during the intraocular lens (IOL) implantation surgery, the lens was coiled. Additional information was received stating that, the issue was noticed when deploying the lens and the lens made contact with the eye but it was not implanted. In the surgeon's opinion, the lens was not made properly caused or contributed to the event. The surgery was completed on the same day and there was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930864 ↗MalfunctionSep 25, 2026Failure to Deliver
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, lens got stuck. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50894671 ↗MalfunctionSep 24, 2026Failure to Deliver
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, the lens was stuck during implantation. The lens was partially inserted and removed, as the lens remained in the delivery system. The originally scheduled procedure was completed on the same day with no patient harm.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 50884058 ↗MalfunctionAug 28, 2026Failure to Advance; Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495542 ↗MalfunctionAug 27, 2026Scratched Material
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, the surgeon noticed a scratch on the lens after insertion. The procedure was completed on the same day. Additional information has been received and stated the lens was subsequently removed and replaced with same company lens, without any harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471181 ↗MalfunctionAug 21, 2026Failure to Advance
A Non health care professional reported that during an intraocular lens (IOL) implant procedure, Plunger over-ride and Plunger was bypassed the IOL.Additional information has been requested.
Patient problems: Insufficient Information
MAUDE report 50361699 ↗MalfunctionAug 13, 2026Device Damaged by Another Device
Patient problems: Insufficient Information
MAUDE report 50234571 ↗MalfunctionAug 12, 2026Material Deformation
A non-healthcare professional reported that, during intraocular lens implantation surgery, the lens was found to be damaged. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50219402 ↗MalfunctionJun 26, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS STRAIGHT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641470 ↗MalfunctionJun 12, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PRELOADED DEVICE FAILED TO DELIVER THE LENS. THE SURGERY WAS COMPLETED WITH A BACKUP LENS. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS DISCARDED.
Patient problems: Insufficient Information
MAUDE report 25485229 ↗MalfunctionJun 1, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED WITH A DESCRIPTION THAT, THERE WAS A SMALL BLACK CLOUDING OR A SMALL BREAKAGE IN THE LENS OPTICS FOR ABOUT 2MM FROM THE HAPTIC CONNECTION. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25349634 ↗MalfunctionMay 8, 2026Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THE INTRAOCULAR LENS (IOL) CAME OUT OF EYEBALL ON INSERTION - SURGEON WANTED TO USE A DIFFERENT LENS AFTER THIS INCIDENT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS NOT DELIVERED ONTO THE EYE AS INTENDED.
Patient problems: Insufficient Information
MAUDE report 25124729 ↗MalfunctionMay 7, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PRELOAD DEVICE HAD BEEN DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25112944 ↗MalfunctionMay 5, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE TRAILING HAPTIC FOLDED WRONG. THE ISSUE WAS NOTED DURING LOADING AND THERE WAS NO PATIENT CONTACT. 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 25084117 ↗MalfunctionApr 20, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED, TRAILING HAPTIC FOLDED WRONG WHEN LOADED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24927268 ↗MalfunctionApr 9, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OVERRODE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24831876 ↗MalfunctionApr 8, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN INJECTOR AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24817404 ↗MalfunctionMar 18, 2026Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PRODUCT FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24627411 ↗MalfunctionMar 18, 2026Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE DEVICE. ADDITIONAL INFORMATION WAS REQUESTED YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24626318 ↗MalfunctionMar 3, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED VIA REPLY CARD THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FAILED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24497328 ↗MalfunctionFeb 27, 2026Failure to Deliver; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE LENS GOT STUCK IN THE INJECTOR. BASED ON NEW INFORMATION PROVIDED, THE LENS WAS NOT IMPLANTED, BECAUSE THE PLUNGER MOVED ALONGSIDE THE OPTIC, CREATING A RISK THAT FURTHER ADVANCEMENT COULD CAUSE OPTIC DAMAGE.
Patient problems: Insufficient Information
MAUDE report 24470190 ↗MalfunctionFeb 23, 2026Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap
ACCORDING TO ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO PATIENT CONTACT AND HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24415383 ↗MalfunctionFeb 20, 2026Material Deformation
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DAMAGED, NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24402450 ↗MalfunctionFeb 20, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS STUCK IN THE INJECTOR AND COULD NOT BE IMPLANTED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24400013 ↗MalfunctionFeb 19, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING A CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT HAD NOT DEPLOYED AND HAD REMAINED STUCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24387087 ↗
Other Lens, multifocal intraocular devices
- 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
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular88 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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