Clareon™ CNA0T0 (REF CNA0T0.090)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 00380652393492), received between Apr 27, 2023 and Dec 5, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).
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
- Device Difficult to Setup or Prepare1
- Failure to Advance1
- Failure to Deliver1
- Failure to Eject1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2025Device Difficult to Setup or Prepare; Off-Label Use; Device Difficult to Setup or Prepare; Off-Label Use
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WENT OUT INCORRECTLY AND ITS SMALL PAW CAME FIRST. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725892 ↗MalfunctionFeb 6, 2025Failure to Deliver; Failure to Advance; Failure to Deliver; Failure to Advance
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS(IOL) STUCK IN DELIVERY SYSTEM OR LENS WOULD NOT ADVANCE AND PLUNGER MISFIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21321357 ↗MalfunctionApr 27, 2023Failure to Eject; Failure to Eject
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LENS ID NOT DISCHARGE FROM THE CARTRIDGE. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THERE WAS NO HARM TO THE PATIENT AND SURGERY WAS COMPLETED WITH A BACK UP DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16822214 ↗
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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