Clareon CNA0T3 (REF CNA0T3.270)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
- 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 00380652398923), received between Aug 8, 2025 and Mar 6, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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
- Activation Problem1
- Failure to Deliver1
- Material Twisted/Bent1
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.
MalfunctionMar 6, 2026Material Twisted/Bent
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING UNKNOWN TIME OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC FAILED AND NOT IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LENS FAILED TO BE INSERTED BECAUSE THE SURGEON NOTICED THAT THE HAPTIC WAS BENT INCORRECTLY IN THE INTRODUCER. THE LENS WAS DISCARDED, AND THERE WAS NO PATIENT CONTACT OR HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24530590 ↗MalfunctionJan 1, 2026Activation Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS CAME OUT TOO QUICKLY BEFORE PLACING THE INJECTOR IN THE EYE. THE PROCEDURE WAS COMPLETED BY USING BACK UP IOL.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23938866 ↗MalfunctionAug 8, 2025Failure to Deliver; Failure to Deliver
A PHYSICIAN REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS CLOGGED AND DID NOT COME OUT WELL BEFORE INSERTION. THE DEFECTIVE LENS WAS NOT IMPLANTED INTO THE EYE AND THE SURGERY WAS PERFORMED AND COMPLETED AFTER REPLACING THE PRODUCT WITH ANOTHER ONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22748837 ↗
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- TECNIS SIMPLICITY DIB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens1 recall81 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens129 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens127 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens126 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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