Clareon™ CNA0T0 (REF CNA0T0.210)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
Quick summary
This Alcon Clareon artificial lens is implanted in the eye during cataract surgery and loaded with a pre-loaded injector. Many of the 113 reports describe the lens sticking, failing to eject or unfold, or a lens arm breaking during loading, and surgeons sometimes used another lens to finish the operation. The reports include 4 injuries and no deaths, and one lists an eye injury. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 112
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 112 adverse event reports that list this exact device (DI 00380652393737), received between Dec 14, 2021 and Sep 28, 2026 — classified as 4 injuries, 108 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (19 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 Deliver19
- Device Difficult to Setup or Prepare18
- Failure to Eject17
- Failure to Advance13
- Device Damaged by Another Device12
- Material Twisted/Bent12
- Defective Device6
- Failure to Fold5
Patient problems
- Insufficient Information58
- No Clinical Signs, Symptoms or Conditions52
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Eye Injury1
- Toxic Anterior Segment Syndrome (TASS)1
- Visual Disturbances1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 112 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Twisted/Bent
A facility Representative reported that during an intraocular lens (IOL) implantation procedure, trailing haptic was bent. Additional information has been received stating the device tip did not come in contact with the patient's eye. The procedure was completed on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922200 ↗MalfunctionSep 25, 2026Device Difficult to Setup or Prepare
A Pharmacist reported that during intraocular lens (IOL) implantation, the rear haptic did not fold properly, resulting in a failure to implant the lens. The device was in contact with the patient's eye. The surgery was completed with a replacement implant. There were no clinical harm or adverse consequence to the patient. 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 50896949 ↗MalfunctionAug 31, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50518267 ↗MalfunctionJul 27, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50037828 ↗MalfunctionJul 27, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50033807 ↗MalfunctionJul 27, 2026Device Damaged by Another Device
A health care professional reported that during an intraocular lens (IOL) implantation procedure, haptic was stuck with plunger and got broken during preparation of lens. The procedure was completed on the same day. The tip of the pre-loaded device was not in contact with the patient as it was stuck during loading under microscope. Additional information has been received and stated surgery was completed with another available company lens in the operation theater and there was no harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50016863 ↗MalfunctionJul 10, 2026Failure to Advance; Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25785950 ↗MalfunctionJun 19, 2026Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHILE INSERTING INTO EYE LENS DID NOT UNFOLD PROPERLY. THE SURGEON HAD TO USE BACK UP LENS TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND YET NO NEW INFORMATION AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 25566455 ↗MalfunctionJun 16, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS STUCK IN THE DEVICE.
Patient problems: Insufficient Information
MAUDE report 25520742 ↗MalfunctionJun 12, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FAILED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25483969 ↗MalfunctionJun 1, 2026Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LEADING HAPTIC UNFOLDED. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25349633 ↗MalfunctionApr 15, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE DEVICE WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24884559 ↗MalfunctionApr 7, 2026Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED STATING WASTED, WOULDN'T EJECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24797810 ↗MalfunctionApr 6, 2026Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THERE WAS NOT ANY PATIENT CONTACT AND THE ISSUES TRAILING HAPTIC THAT DID NOT FOLD CORRECTLY WAS DETERMINED AT LOADING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24796054 ↗MalfunctionApr 6, 2026Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS TWISTED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789425 ↗MalfunctionApr 5, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) LENS STUCK IN COMPANY PRELOADED INJECTOR. THE LENS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24786715 ↗MalfunctionApr 2, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24772516 ↗MalfunctionMar 16, 2026Material Twisted/Bent
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A DEFECT WAS NOTICED - THE HAPTIC WAS TWISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PHYSICIAN HAS NOTICED THE HAPTIC WAS TWISTED PRIOR TO ANY PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY. IN THE SURGEON'S OPINION THE DEVICE WAS MANUFACTURED INCORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24603451 ↗MalfunctionMar 9, 2026Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24545612 ↗MalfunctionMar 7, 2026Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEVICE HAD A MALFUNCTION WITH LENS LOADING DIFFICULTIES/HARD TO INSERT INTO THE CARTRIDGE/WOULD NOT LOAD. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24540926 ↗MalfunctionMar 7, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BACK HAPTIC BENT AND TWISTED. THE PROCEDURE WAS COMPLETED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT IN THE SURGEON¿S OPINION THE PLUNGER WAS TO FAR TO THE RIGHT AND CAUSED THE TRAILING HAPTIC TO BEND AND TWIST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24539876 ↗MalfunctionMar 6, 2026Failure to Advance; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PLUNGER WENT TO THE RIGHT AND CAUSED THE BACK HAPTIC TO TWIST AND FOLD. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT WITH DEVICE. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT WITH THE PRODUCT LISTED BELOW. PER THE REPORTER IT SEEMS TO BE THE PLUNGER THAT IS TOO FAR TO THE RIGHT OF THE TRAILING HAPTIC AND THEN CAUSES THE HAPTIC TO CRUMPLE AND TWIST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24531421 ↗MalfunctionMar 2, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS COULD NOT BE INSERTED DUE TO HAPTIC BENT AND IT WAS PROTRUDING OUT FROM LENS INSIDE THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24482210 ↗MalfunctionFeb 27, 2026Failure to Fold; Device Damaged by Another Device
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE LENS DID NOT FOLD PROPERLY, RESULTING IN LENS WRINKLES. THE BACKUP LENS 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 24470665 ↗MalfunctionFeb 20, 2026Failure to Deliver
ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT, WHEN THE LENS WAS OPENED ON THE STERILE FILED, THE PLASTIC PIECE TO ADVANCE FELL OFF.
Patient problems: Insufficient Information
MAUDE report 24399875 ↗
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 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
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular88 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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