Clareon™ CNA0T0 (REF CNA0T0.060)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652393430), received between Feb 10, 2025 and Sep 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Deliver2
- Device Difficult to Setup or Prepare1
Patient problems
- Insufficient Information3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Failure to Deliver
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the plunger did not deploy correctly. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50774469 ↗MalfunctionMay 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAILURE PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21970405 ↗MalfunctionFeb 10, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE; THE SURGEON NOTICED THAT THE FAULTY INJECTOR LENS WOULD NOT ADVANCE/ LENS STUCK IN LOADER WITH PATIENT CONTACT. AS PER SURGEON'S OPINION FAULTY INJECTOR CAUSED OR CONTRIBUTED TO THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING BACKUP LENS USED.
Patient problems: Insufficient Information
MAUDE report 21342882 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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