Clareon CNA0T4 (REF CNA0T4.145)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652399241), received between Mar 14, 2025 and Mar 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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
- Failure to Deliver1
- Material Twisted/Bent1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING LOADING THE LENS IT WAS NOTICED THAT THE LENS WAS MOVING FORWARD WITH HAPTIC ANGLED INCORRECTLY. THERE WAS A PATIENT CONTACT WITH THE DEVICE. SURGERY WAS COMPLETED ON THE SAME DAY WITH REPLACEMENT LENS WITHOUT ANY PATIENT HARM. HENCE THE PATIENT'S ISSUES WAS RESOLVED AND IN THE SURGEON¿S PROGNOSIS THE PATIENT CONDITION WAS SATISFACTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24726813 ↗MalfunctionMar 14, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION, IMPLANT WAS STUCK IN THE INJECTOR WHEN TRYING TO USE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21613031 ↗
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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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