Clareon CNA0T4 (REF CNA0T4.215)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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380652399388), received between Jul 9, 2024 and May 1, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (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
- Failure to Deliver2
- Failure to Unfold or Unwrap2
- Device Difficult to Setup or Prepare1
- Ejection Problem1
- Failure to Fold1
Patient problems
- Insufficient Information5
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 1, 2026Failure to Deliver
A PHYSICIAN REPORTED WITH THE DESCRIPTION OF LENS GOT STACKED DUE TO WHICH IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION HAS BEEN RECEIVED.
Patient problems: Insufficient Information
MAUDE report 25054668 ↗MalfunctionApr 15, 2026Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS STUCK ON POSTERIOR OPTIC, THAT WAS DIFFICULT TO PRY AWAY. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WERE NO ISSUES WITH PREPPING OF COMPANY PRODUCT, COMPANY VISCOELASTICS, NOT COLD AND NOT PREPPED TOO EARLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGEON HAD MANAGED TO PRY THE HAPTIC AWAY EVENTUALLY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886619 ↗MalfunctionDec 28, 2025Failure to Fold; Failure to Fold
A PHARMACIST REPORTED THAT DURING SURGERY, THEY NOTICED A FOLDING DEFECT IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE BACK UP LENS WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 23903333 ↗MalfunctionNov 19, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS DID NOT OPEN AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23591179 ↗MalfunctionNov 6, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT THE TRAILING ARM WAS NOT FOLDED PROPERLY. ADDITIONAL INFORMATION WAS REQUIRED.
Patient problems: Insufficient Information
MAUDE report 23486652 ↗MalfunctionJul 7, 2025Failure to Deliver; Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THERE WAS AN INJECTION ISSUE, LENS WAS BLOCKED IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 22413796 ↗MalfunctionJul 9, 2024Ejection Problem; Ejection Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PROBLEM OCCURRED WITH INJECTION WITH PATIENT CONTACT. NO CONSEQUENCES FOR THE PATIENT WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19699028 ↗
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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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