Clareon CNA0T4 (REF CNA0T4.240)Recalls & reported problems
Alcon Laboratories, Inc. · CLAREON TORIC AUTONOME · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00380652399432), received between Apr 16, 2024 and Jun 16, 2026 — classified as 6 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare3
- Failure to Advance1
- Failure to Deliver1
- Material Twisted/Bent1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 16, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC FOLDED WRONG. THE SURGERY COMPLETED WITH REPLACEMENT LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25522978 ↗MalfunctionMar 7, 2026Failure to Advance
A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR PISTON MOVED TO THE RIGHT FROM THE BEGINNING OF THE MOVEMENT. IT HAD TO BE STRAIGHTENED MANUALLY USING A MICROMANIPULATOR HOOK. NO CLINICAL CONSEQUENCES OBSERVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541107 ↗MalfunctionFeb 27, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS TWISTED AND FAILED TO INJECT PROPERLY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471540 ↗MalfunctionFeb 16, 2026Device Difficult to Setup or Prepare
A PHARMACIST REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, INSERTION WAS IMPOSSIBLE DESPITE A 2.4 MILLIMETRE INCISION. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH NO CLINICAL CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24344554 ↗MalfunctionDec 25, 2025Device Difficult to Setup or Prepare; Product Quality Problem; Device Difficult to Setup or Prepare; Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED DIFFICULTY WHILE ADVANCING THE IMPLANT THROUGH THE INJECTOR. THE IMPLANT CAME OUT COMPLETELY DEFORMED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23891624 ↗MalfunctionApr 16, 2024Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF THE INTRAOCULAR LENS ( IOL) GOT STUCK AND DIDN'T COME OUT OF THE CARTRIDGE SMOOTHLY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS AND THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19117319 ↗
Other Intraocular Lens devices
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens146 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens145 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens144 reports
- TECNIS IOL PCB00Johnson & Johnson Surgical Vision, Inc. · intraocular lens139 reports
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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