Clareon™ CNA0T0 (REF CNA0T0.280)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
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00380652396493), received between Sep 15, 2022 and Jul 14, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 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
- Device Difficult to Setup or Prepare3
- Failure to Advance2
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Failure to Deliver1
- Malposition of Device1
- Material Twisted/Bent1
- Unintended Ejection1
Patient problems
- Insufficient Information7
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Break; Failure to Advance; Malposition of Device
Patient problems: Insufficient Information
MAUDE report 25815776 ↗MalfunctionMay 20, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IMPLANT WAS TOO RIGID. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25229137 ↗MalfunctionMay 4, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF TRAILING HAPTIC FOLDED WRONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25070826 ↗MalfunctionNov 4, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23463862 ↗MalfunctionMay 30, 2025Failure to Deliver; Material Twisted/Bent; Failure to Deliver; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANT PROCEDURE THE LENS WOULD NOT ADVANCE INTO EYE THROUGH INCISION. SCRUB TECH LOADED LENS INTO COMPANY INJECTOR AND HAD ISSUES WITH IT DEPLOYING. THERE WAS A PATIENT CONTACT AND PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT LEADING HAPTIC ON LENS WAS TWISTED AND THIS MADE THE LENS STICK WHILE ENTERING THE INCISION. LENS WAS REMOVED AND RELOADED, MANUALLY, BUT THE ISSUE PERSISTED, AND THE SURGEON WAS UNABLE TO GET IT COMPLETELY IN THE EYE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22114278 ↗MalfunctionDec 26, 2023Unintended Ejection; Unintended Ejection
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS INJECTED IN THE EYE, THE LENS GOT STUCK AND CAME OUT OF THE WOUND WITH THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18392993 ↗MalfunctionOct 23, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ADDITIONAL INFORMATION HAS BEEN RECEIVED FROM THE FACILITY AND STATED THAT LENS WAS LOADED, WHEN INSERTION WAS ABOUT TO HAPPEN, INCISION WAS NOTED TO BE TOO SMALL. SURGEON ENLARGED THE INCISION AND WHEN SURGEON WAS ABOUT TO INSERT THE LENS, THE LENS WAS OUT TOO MUCH. THE ORIGINALLY SCHEDULED PROCEDURE COMPLETED ON THE SAME DAY, AS PER THE SURGEON¿S OPINION PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 17983240 ↗MalfunctionSep 15, 2022Failure to Advance; Failure to Advance
A NON HEALTH PROFESSIONAL REPORTED THAT THE LENS DIDN'T LOAD PROPERLY AND THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15427143 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page