Clareon CNA0T3 (REF CNA0T3.255)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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652398893), received between Aug 22, 2025 and Apr 21, 2026 — classified as 4 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. 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 Prepare2
- Inaccurate Delivery1
- Material Deformation1
- Scratched Material1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC CAME OUT BACKWARDS, LENS DID NOT MAKE CONTACT WITH PATIENT'S EYE AND USED BACK UP LENS INSTEAD. THE PROCEDURE WAS COMPLETED ON SAME DAY WITH NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24948556 ↗MalfunctionMar 30, 2026Inaccurate Delivery; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS GOT STUCK MID WOUND. SURGEON TRIED TO PRY LENS OFF THE INJECTOR BUT NOTICED THERE WAS A SCRATCH OR DENT IN IT. HENCE THE LENS WAS CUT AND REMOVED FROM THE PATIENT EYE AND A NEW LENS OF SAME DIOPTER WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24728075 ↗MalfunctionMar 30, 2026Material Deformation
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON FELT THERE WAS A FILM OR SUB SURFACE NANO GLISTENINGS ON LENS ON CONSULT TWO YEARS AFTER LENS IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE LENS WAS NOT EXPLANTED AND THERE WAS NO PLAN TO EXPLANT THE LENS.
Patient problems: Insufficient Information
MAUDE report 24717353 ↗MalfunctionAug 22, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF INJECTOR WAS DEFECTIVE.ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22872906 ↗
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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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