Clareon™ CNA0T0 (REF CNA0T0.115)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
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652393546), received between Mar 3, 2025 and Jan 5, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (2 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 Prepare2
- Failure to Deliver2
- Failure to Advance1
- Material Twisted/Bent1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 5, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATES THAT DURING THE TIME OF IMPLANTATION, WHILE DEPLOYING THE LENS THE HAPTIC CAME OUT STRAIGHT AND IT WAS NOTICED THAT BEFORE PUTTING INTO THE PATIENT'S EYE. BUT THE TIP OF THE DEVICE HAD A PATIENT CONTACT AND THE LENS REMAINED IN THE DELIVERY SYSTEM. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REQUESTING ANOTHER UNSPECIFIED LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957625 ↗MalfunctionNov 14, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT, ACCORDING TO THE SURGEON, THE HAPTICS OF THE INTRAOCULAR LENS (IOL) APPEARED TO BE OUT OF PROPER POSITION. THEREFORE, THE IOL WAS NOT IMPLANTED OR UTILIZED. ADDITIONAL INFORMATION WAS REQUESTED. THE CUSTOMER WAS UNABLE TO PROVIDE ANY FURTHER INFORMATION REGARDING THIS CASE.
Patient problems: Insufficient Information
MAUDE report 23553103 ↗MalfunctionJul 22, 2025Failure to Deliver; Failure to Deliver
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT WHEN TRYING TO INSERT THE LENS, THE LENS DID NOT DEPLOY PROPERLY FROM THE INJECTOR. THE PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 22566728 ↗MalfunctionMay 26, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION; THE IMPLANT WAS STUCK IN THE INJECTOR AND WAS NOT USED. THERE WAS NO CLINICAL CONSEQUENCE FOR THE PATIENT AND AN IDENTICAL MODEL REPLACEMENT WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22084034 ↗MalfunctionMar 3, 2025Failure to Advance; Failure to Advance
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE LOADER WAS BROKEN AND THE PRODUCT WAS NOT AVAILABLE FOR RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21506392 ↗
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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