Clareon™ CNA0T0 (REF CNA0T0.120)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 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 00380652393553), received between May 4, 2023 and Feb 20, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Device Damaged by Another Device” (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 Damaged by Another Device2
- Device Difficult to Setup or Prepare2
- Defective Device1
- Failure to Eject1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT WHILE LENS WAS BEING ADVANCED IN INJECTOR, A LARGE AMOUNT OF SMOKE CAME FROM THE MIDDLE OF THE INJECTOR. THE PROCEDURE COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24400011 ↗MalfunctionOct 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHARMACIST REPORTED WITH A DESCRIPTION OF DEFECTIVE CARBON DIOXIDE GAS CARTRIDGE LEAKAGE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE EVENT OCCURRED DURING PREPARATION OF IMPLANT, BEFORE INJECTION. THE SURGERY WAS COMPLETED WITH THE BACKUP LENS. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23301462 ↗MalfunctionAug 19, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE DETACHED ANTERIOR HAPTIC OF THE IOL WAS RELEASED INTO THE ANTERIOR CHAMBER. THE REST OF THE LENS REMAINED AT THE BOTTOM OF THE CARTRIDGE. THE SURGEON DID NOT NOTICED BEFORE IMPLANTATION THAT ONLY THE ANTERIOR HAPTIC WAS IN THE NOZZLE IN FRONT OF THE PLUNGER, AS THE SYSTEM HAD ALWAYS WORKED RELIABLY. SUBSEQUENTLY, DETACHED HAPTIC WAS REMOVED FROM THE EYE DURING INITIAL PROCEDURE.THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH ANOTHER UNSPECIFIED REPLACEMENT LENS WITHOUT ANY ISSUES OR COMPLICATIONS.
Patient problems: Insufficient Information
MAUDE report 22840035 ↗MalfunctionAug 6, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT THE LENS JAMMED INTO THE INJECTOR DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THERE WAS NO HARM TO THE PATIENT, AND THE SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19919281 ↗MalfunctionJun 5, 2024Defective Device; Defective Device
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DAMAGED DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19465841 ↗MalfunctionMay 4, 2023Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS CRUMBLED LIKE A PIECE OF PAPER WHEN INSERTED IN THE PATIENT'S EYE. ADDITIONAL INFORMATION WAS REQUESTED AND RECEIVED STATING LENS WAS CRUMPLED IN THE LOADER. WHEN IT WAS ENGAGED TO MOVE LENS FORWARD. IT WAS NOT A LEAN FOLD. IT LOOKED LIKE A CRUMBLED PIECE OF PAPER. DOCTOR HAD TO ENGAGE SLOWLY WHILE USING A MALONY TO GET THE LENS IN THE DESIRED LOCATION IN THE EYE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16866730 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular1 recall66 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular113 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular112 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular110 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular107 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular104 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular93 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.
How reports and recalls are matched · Editorial policy · Report an error on this page