Clareon™ CNA0T0 (REF CNA0T0.200)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 multifocal intraocular lens comes in a pre-loaded delivery system used during eye surgery. Its 92 reports, with 9 injuries and no deaths, often describe the delivery system not advancing or ejecting the lens properly, the lens arriving scratched or damaged, and the lens being hard to set up, and in several cases surgeons finished the procedure with a different lens. No recalls name this device. Reports for the last 12 months (31) are more than in the previous 12 months (18).
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
- 93
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 93 adverse event reports that list this exact device (DI 00380652393713), received between Oct 19, 2021 and Sep 29, 2026 — classified as 8 injuries, 85 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (15 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 Prepare15
- Failure to Eject14
- Failure to Advance11
- Defective Device10
- Failure to Deliver10
- Device Damaged by Another Device8
- Material Twisted/Bent8
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- Insufficient Information52
- No Clinical Signs, Symptoms or Conditions33
- Visual Impairment4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Blurred Vision2
- Capsular Bag Tear2
- Corneal Edema2
- Fibrosis2
Recent adverse event reports
The 25 most recent of 93 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Twisted/Bent
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, that the haptic was deformed/asymmetric. Surgeon opened back up lens and originally scheduled procedure was completed on the same day. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50933047 ↗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 had 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 29 of 29.
Patient problems: Insufficient Information
MAUDE report 50867617 ↗MalfunctionSep 22, 2026Failure to Deliver
A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, the lens was stuck at the tip of the nozzle during deployment.Additional information was requested but was not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50852355 ↗MalfunctionAug 10, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, the delivery system was defective and it was not used.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50190113 ↗MalfunctionJul 28, 2026
A physician reported with a description of lens was not loaded correctly. The procedure was completed with another lens.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50055477 ↗MalfunctionJul 17, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25854564 ↗MalfunctionJun 26, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED HAPTIC WAS STRAIGHT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT EVENT HAPPENED DURING PRE-LOADING. THE SURGERY COMPLETED ON SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25637139 ↗MalfunctionJun 12, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS NOTICED THAT WHEN INJECTED TO PATIENT'S EYE THE LENS WAS MESSED UP. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS WAS INSERTED AND SURGEON NOTICED IT WAS DEFECTIVE. SURGERY WAS COMPLETED BY REMOVING THE ORIGINAL LENS AND REPLACING IT WITH THE SAME MODEL AND DIOPTER COMPANY LENS DURING THE INITIAL PROCEDURE ON THE SAME DAY. THERE WAS NO FURTHER IMPACT ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485059 ↗MalfunctionMay 4, 2026Device Difficult to Setup or Prepare; Scratched Material
A PHARMACIST REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS ACTIVATED AND ADVANCED. UPON ADVANCEMENT, IT WAS OBSERVED THAT THE FIRST HAPTIC WAS INCORRECTLY FOLDED POSTERIORLY TOWARD THE BACK OF THE LENS. THE LENS WAS THEN INJECTED EXTERNALLY, LENS WAS FOUND TO BE SCRATCHED/DEFACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25075898 ↗MalfunctionApr 11, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS DEFECTIVE. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS A PATIENT CONTACT. THERE WAS 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 24852085 ↗MalfunctionMar 31, 2026Failure to Deliver
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THAT THE ISSUE HAPPENED DURING ADVANCEMENT OF THE IMPLANT, WITHIN THE INJECTION SYSTEM / CARTRIDGE. THE PROCEDURE WAS COMPLETED THE SAME DAY WITH SAME DIOPTER COMPANY LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24743785 ↗MalfunctionMar 23, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOT INJECTING. LENS DID NOT INJECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24662232 ↗MalfunctionMar 17, 2026Failure to Prime; Material Deformation; Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TIP/DISTAL PORTION WAS BENT. LENS WOULD NOT ADVANCE THROUGH APERTURE. THERE WAS POSSIBLE STRAIGHT TRAILING HAPTIC. THE PROCEDURE WAS COMPLETED ON SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24617259 ↗MalfunctionMar 3, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED AN ISSUE DESCRIBED AS A DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24496968 ↗InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT WAS NOT HAPPY WITH RESULTS. CLINICAL REASON FOR PATIENT WAS NOT SEEING CLEARLY. THE IOL WAS EXCHANGED FOR MONOFOCAL LENS 23 DAYS FOLLOWING THE INITIAL IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 24472284 ↗MalfunctionFeb 27, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT ADVANCE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, SURGEON MANAGED TO INSERT THE SAME LENS AND COMPLETED THE PROCEDURE ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 24470192 ↗MalfunctionFeb 27, 2026Material Deformation
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THERE WAS AN ABNORMALITY WITH THE TIP OF THE INJECTOR BEFORE PLACING THE IMPLANT. THEREFORE, THE LENS WAS NOT USED, AND THE BACKUP LENS WAS USED.
Patient problems: Insufficient Information
MAUDE report 24469473 ↗MalfunctionFeb 23, 2026Device Difficult to Setup or Prepare; Failure to Unfold or Unwrap
THE HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY HAPTIC WAS STUCK UNDER THE LENS. THE SURGERY WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT, THERE IS NO PATIENT CONTACT AND NO PATIENT HARM. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 3 FILES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24424683 ↗MalfunctionFeb 19, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC BECAME STUCK BETWEEN THE INSERTER AND THE CARTRIDGE AND COULD NOT BE RELEASED. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THE HAPTIC WAS RELEASED USING NON-COMPANY FORCEPS. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24388974 ↗MalfunctionFeb 16, 2026Material Twisted/Bent
A CUSTOMER REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS BENT TO THE LEFT IN THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 24344037 ↗MalfunctionFeb 13, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS HAPTIC WAS BENT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE ISSUE OCCURRED DURING PRELOADING OF THE LENS WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331269 ↗MalfunctionFeb 12, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANT STUCK IN THE INJECTOR. THE DUPLICATE WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24329604 ↗MalfunctionJan 20, 2026Failure to Deliver; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE LENS FOLDED AND BECAME STUCK IN THE INJECTOR, MAKING IMPLANTATION IMPOSSIBLE. THE PUSHER PASSED UNDERNEATH THE LENS AND THE LENS WAS NOT USABLE. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24126992 ↗MalfunctionJan 13, 2026Device Difficult to Setup or Prepare; Failure to Prime; Material Twisted/Bent
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE ISSUE WAS STRAIGHT LEADING HAPTIC AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052049 ↗MalfunctionJan 8, 2026Inaccurate Delivery
NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED EXTERIORIZATION AT THE EDGE. THE LENS DID NOT FULLY ENTER THE EYE; IT REMAINED AT THE INCISION EDGE. THE SURGERY WAS COMPLETED WITH SAME MODEL BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24006509 ↗
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 intraocular88 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.