Clareon™ CNA0T0 (REF CNA0T0.250)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
Quick summary
This Alcon Clareon CNA0T0 is a foldable intraocular lens that replaces the eye's natural lens in cataract surgery, delivered pre-loaded in an injector. The 31 reports mostly describe handling problems during surgery: the lens or its haptics failing to advance, eject, or release from the injector, haptics twisting or folding, and scratches. One report describes a torn capsular bag, with one injury and no deaths. No recalls name this device, and reports have risen from 5 to 13 in the past 12 months.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00380652393812), received between Nov 23, 2021 and Sep 17, 2026 — classified as 1 injury, 30 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (10 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare10
- Failure to Advance6
- Failure to Eject4
- Defective Device3
- Failure to Deliver3
- Scratched Material2
- Activation Problem1
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information17
- No Clinical Signs, Symptoms or Conditions13
- Capsular Bag Tear1
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Failure to Advance
A non-healthcare professional reported that, during an intraocular lens (IOL) implantation procedure, the lens did not inject correctly. The injection of lens did not come properly through the injector.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50799615 ↗MalfunctionAug 26, 2026Material Twisted/Bent
A healthcare professional reported that during an intraocular lens (IOL) implant procedure, the leading haptic got twisted.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50452386 ↗MalfunctionAug 11, 2026Failure to Advance
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, the plunger was defective.
Patient problems: Insufficient Information
MAUDE report 50208049 ↗MalfunctionJul 14, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25812918 ↗MalfunctionJul 10, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC FOLDED ONTO THE BACK PART OF THE OPTIC. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, ISSUE WAS NOTICED DURING PRIMING AND THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25777019 ↗MalfunctionMay 29, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WOULD NOT RELEASE FROM THE PRE-LOAD DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25330124 ↗MalfunctionMay 20, 2026Device Difficult to Setup or Prepare
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC STUCK IN THE INJECTOR. THE SURGERY WAS COMPLETED ON THE SAME DAY USING THE BACK UP LENS AND THE SAMPLE WAS DISCARDED.
Patient problems: Insufficient Information
MAUDE report 25231969 ↗MalfunctionMar 16, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC FOLDED BEHIND THE OPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24607469 ↗MalfunctionMar 12, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REQUESTING ASSISTANCE IN REPLACING THESE LENSES AS SOON AS POSSIBLE, AS THEY WERE REPORTED AS DEFECTIVE LAST WEEK BY VAN BUREN HOSPITAL AND ALSO REQUESTING YOUR ASSISTANCE IN REPLACING OLDER LENSES THAT HAVE ALREADY BEEN REPORTED TO LACAR BUT HAVE NOT YET BEEN REPLACED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24581838 ↗MalfunctionFeb 5, 2026Device Difficult to Setup or Prepare; Failure to Advance
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEVICE MALFUNCTIONED. ADDITIONAL INFORMATION HAS BEEN RECEIVED AS THE PLUNGER BYPASSED THE IOL AND IT WAS NOT ABLE TO BE DISCHARGED FROM THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 24268805 ↗MalfunctionJan 7, 2026Failure to Deliver; Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WOULD NOT ADVANCE OR THE PLUNGER BYPASSED THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23988113 ↗InjuryDec 19, 2025Activation Problem; Activation Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IN A 4-MONTH-OLD BABY, IT WAS NOTED THAT THE LENS WAS RELEASED TOO QUICKLY AND THE PATIENT HAD A CAPSULE RUPTURE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE AND REPLACED WITH SAME MODEL AND DIOPTER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 23849819 ↗MalfunctionDec 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A SURGICAL TECHNOLOGIST REPORTED THAT THE INJECTOR WAS "SMOKING" ONCE THE LEVER WAS PRESSED DOWN TO ENGAGE THE LENS, POSSIBLY DUE TO AN ISSUE WITH THE CO2 CARTRIDGE. THE ISSUE OCCURRED DURING SURGERY. ONLY THE TIP OF THE NOZZLE WAS INSERTED INTO THE INCISION, THEREFORE, THERE WAS LITTLE PATIENT CONTACT, AND THE LENS WAS NEVER INSERTED INTO THE EYE. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 23787931 ↗MalfunctionAug 22, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Damaged by Another Device; Device Difficult to Setup or Prepare; Failure to Advance; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, VISCOELASTIC WAS PLACED AS INDICATED FOR ASSEMBLY AND LENS WAS ADVANCED. IT WAS EVIDENCED THAT THE PLUNGER WAS ON THE OPTIC AND THE HAPTIC WAS SCREWED. DOCTOR EXAMINES IT UNDER A MICROSCOPE AND DECIDES TO REMOVE THE LENS FROM THE INJECTOR. A PARACENTRAL MARK WAS FOUND ON THE OPTIC RELATED TO POOR POSITIONING OF THE PLUNGER AND HAPTIC. THE LENS HAD NO CONTACT WITH THE PATIENT. DOCTOR REQUESTED A NEW LENS OF SAME MODEL AND DIOPTER, WHICH WAS IMPLANTED WITHOUT COMPLICATIONS. THERE WAS NO IMPACT TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22871000 ↗MalfunctionJun 13, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHARMACIST REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THERE WAS AN INJECTION ISSUE. HENCE THE BACK UP LENS WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22203199 ↗MalfunctionJan 10, 2025Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PROBLEM WITH THE INJECTOR. PROCEDURE WAS COMPLETED WITH ANOTHER IOL. NON COMPANY VISCOELASTIC WAS USED. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21124647 ↗MalfunctionDec 12, 2024Material Discolored; Material Discolored
A HEALTHCARE PROFESSIONAL REPORTED THAT E HAD NOTICED RESIDUE ON THE IOL INTRAOPERATIVELY WHICH DISAPPEAR POSTOPERATIVELY. THE LENS REMAINS IMPLANTED IN EYE.
Patient problems: Insufficient Information
MAUDE report 20914372 ↗MalfunctionNov 22, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) GOT STUCK DURING IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE LEADING HAPTIC GOT STUCK AND NO FURTHER MANIPULATION WAS DONE. THE PROCEDURE WAS COMPLETED USING COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 20759995 ↗MalfunctionOct 30, 2024Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC WHEN INSERTING INTO EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20568884 ↗MalfunctionAug 22, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY NOTICED THAT LENS STUCK IN INCISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20025087 ↗MalfunctionJul 23, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON HAD MENTIONED THAT THE PLUNGER UNDERRIDE THE LENS WAS NOTICED.
Patient problems: Insufficient Information
MAUDE report 19803902 ↗MalfunctionJul 4, 2024Failure to Advance; Failure to Advance
ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE DEVICE WAS PREPARED BY PUTTING VISCOELASTIC IN THE CARTRIDGE, THEN THEY REMOVED THE SAFETY CATCH AND PRIMED THE IMPLANT. THE PLUNGER DEVIATED FROM THE TRAJECTORY, JAMMING THE IMPLANT IN THE CARTRIDGE. THE EVENT OCCURRED BEFORE THE INJECTOR WAS INTRODUCED INTO THE PATIENT'S EYE, SO THE INJECTOR DID NOT TOUCH THE PATIENT'S EYE. THE SURGERY WAS COMPLETED ON SAME DAY USING A COMPANY PRELOADED DEVICE.
Patient problems: Insufficient Information
MAUDE report 19675075 ↗MalfunctionJul 5, 2023Malposition of Device; Scratched Material; Material Split, Cut or Torn; Malposition of Device; Scratched Material; Material Split, Cut or Torn
AN OTHER HEALTH CARE PROFESSIONAL REPORTED THAT LENS WAS STUCK INSIDE THE APPLICATOR, LENS WAS ALSO SCRATCHED. ACCORDING TO ADDITIONAL INFORMATION, THE LENS TORE AND BECAME CAUGHT IN THE CONJUNCTIVE DURING INSERTION, AND IT ALSO SUFFERED DAMAGE AFTER BEING REMOVED FROM THE WOUND. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17254614 ↗MalfunctionJun 13, 2023Fogging; Fogging
A NURSE REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS APPEARED TO HAVE FOGGY AND HAZY FILM APPEARANCE. ADDITIONAL INFORMATION WAS REQUESTED BUT NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 17115970 ↗MalfunctionJan 4, 2023Defective Device; Defective Device
A PHYSICIAN REPORTED DURING THE CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS IDENTIFIED THAT, THE PLUNGER WAS SLIGHTLY CROOKED. THERE WAS PATIENT CONTACT BUT NO INCIDENCE OR IMPACT. THE IMPLANT WAS WELL INJECTED AND REMAINS IN THE EYE. ADDITIONAL INFORMATION HAS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16094406 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.