Clareon™ CNA0T0 (REF CNA0T0.170)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 presbyopia-correcting artificial lens implanted during cataract surgery, delivered through a preloaded injector. Most of the 26 reports describe the lens failing to come out of the cartridge or unfold properly during implantation, plus haptics breaking or being damaged. There are 25 malfunctions, 1 injury and no deaths, and 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
- 28
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00380652393652), received between May 7, 2022 and Sep 22, 2026 — classified as 1 injury, 27 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (4 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
- Failure to Advance4
- Failure to Deliver4
- Failure to Eject4
- Device Damaged by Another Device3
- Break2
- Defective Component2
- Defective Device2
- Device Difficult to Setup or Prepare2
Patient problems
- Insufficient Information15
- No Clinical Signs, Symptoms or Conditions12
- Intraocular Pressure Increased1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Deformation
A physician reported that subsurface nano glistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been requested, received and stated there has been no visual impact to patient at all.There are multiple medical reports associated with same event. This file is 17 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857584 ↗MalfunctionSep 22, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been requested and received states that there has been no visual impact to patient.There are multiple medical reports associated with same event. This file is 7 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50855627 ↗MalfunctionJul 30, 2026Failure to Advance; Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50085789 ↗MalfunctionApr 9, 2026Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC BROKE INTO THE INJECTOR. ACCORDING TO THE NEW INFORMATION RECEIVED STATED THAT THERE WAS NO PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832969 ↗MalfunctionMar 16, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS JAMMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24603452 ↗MalfunctionMar 3, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT TRAILING HAPTIC DID NOT UNFOLD AND WAS A ONETIME OCCURRENCE. LENS WAS DISCARDED AND NOT IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24496963 ↗MalfunctionSep 5, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LEADING HAPTIC WAS EXTENDED AND TURNED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE PROCEDURE COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22978099 ↗MalfunctionAug 28, 2025Failure to Advance; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT DEPLOY PROPERLY. THE INJECTOR WENT PAST THE LENS AND DID NOT PUSH LENS FORWARD. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22911860 ↗MalfunctionAug 8, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL STAYED IN THE INSERTER AND THE INSERTER PASSED RIGHT PAST THE LENS. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE LENS DID NOT COME OUT OF THE CARTRIDGE DURING IMPLANTATION.
Patient problems: Insufficient Information
MAUDE report 22747599 ↗MalfunctionJun 2, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE LENS WAS STUCK IN THE DEVICE AND LENS WOULD NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22122756 ↗MalfunctionMay 29, 2025Break; Material Twisted/Bent; Break; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE TRAILING HAPTICS WAS STRAIGHT DOWN, FOLDING ISSUE AND THE LEADING HAPTICS APPEARED BROKEN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22104170 ↗MalfunctionMay 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTIC WAS STUCK IN BETWEEN THE PLUNGER AND NOZZLE TIP AND CAUSED THE TRAILING HAPTIC BROKEN. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22028387 ↗MalfunctionApr 30, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN LOADER. THERE WAS PATIENT CONTACT. PROCEDURE COMPLETED THE SAME DAY WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21934146 ↗MalfunctionMar 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TORN LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21527216 ↗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 21411164 ↗MalfunctionJan 16, 2025Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, ALL THE LENSES WERE USED ON THE SAME PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21166701 ↗MalfunctionJan 9, 2025Break; Failure to Eject; Break; Failure to Eject
THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER PASSES OVER THE LENS WHEN LENS WAS ADVANCED AND LOWER HAPTICS WAS BROKEN. THERE WAS NO PATIENT CONTACT AND IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112444 ↗MalfunctionDec 31, 2024Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED BEFORE A CATARACT REMOVAL AND INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC PROBLEM WAS NOTICED AND NOT USED. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21047490 ↗MalfunctionJul 26, 2024Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS WAS NOT FOLDED CORRECTLY, UNABLE TO UNFOLD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19835948 ↗MalfunctionFeb 29, 2024Defective Device; Defective Device
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS AN INJECTOR MALFUNCTION. HENCE THE LENS WAS REMOVE AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 18808104 ↗MalfunctionFeb 12, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INJECTOR SHAFT GOT UNDER THE OPTICAL PART OF THE LENS. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18684048 ↗MalfunctionJan 5, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENSES NOT IMPLANTED, DUE TO INJECTOR MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18450439 ↗MalfunctionOct 4, 2023Particulates; Particulates
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PHYSICIAN WHITE SHEEN ON THE ANTERIOR SURFACE OF THE LENS. THE WHITE SHEEN REMAINS EVEN AFTER THE REMOVAL OF THE OPHTHALMIC VISCOELASTIC DEVICE. THE LENS WAS LEFT IN THE PATIENTS EYE AND WILL BE MONITORED.
Patient problems: Insufficient Information
MAUDE report 17870385 ↗MalfunctionJun 8, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, THERE WAS NO PATIENT CONTACT WITH THE DEVICE AND PLUNGER OVERRIDE WAS OBSERVED FROM THE RETURNED LENS.
Patient problems: Insufficient Information
MAUDE report 17086985 ↗MalfunctionMar 14, 2023Defective Component; Device Damaged by Another Device; Defective Component; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PLUNGER OF THE AUTOSAMPLER TRAPPED THE PROXIMAL HAPTIC AND PARTIALLY AMPUTATED IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEW COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 16535414 ↗
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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