Clareon™ CNA0T0 (REF CNA0T0.185)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 lens used to replace the eye's natural lens during cataract surgery. Most of the 57 reports describe the pre-loaded delivery system not working as expected at the operating table — the lens failing to advance or eject, sticking in the injector, twisted or bent haptics, and difficulty setting it up. Four reports mention patient injury, and no deaths were reported. There are no recalls naming 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
- 59
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00380652393683), received between Feb 24, 2022 and Sep 28, 2026 — classified as 4 injuries, 55 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (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
- Failure to Advance10
- Failure to Deliver9
- Device Difficult to Setup or Prepare7
- Defective Device5
- Failure to Eject5
- Material Twisted/Bent5
- Adverse Event Without Identified Device or Use Problem4
- Device Damaged by Another Device4
Patient problems
- Insufficient Information38
- No Clinical Signs, Symptoms or Conditions18
- Toxic Anterior Segment Syndrome (TASS)2
- Blurred Vision1
- Inflammation1
- Visual Impairment1
Recent adverse event reports
The 25 most recent of 59 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Device Damaged by Another Device
A non-healthcare professional reported that during a cataract surgery with intraocular lens (IOL) implantation procedure, the injector was defective, resulting in the lens breaking.Additional information has been requested and received by stating the injector did not properly advance the lens.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50912819 ↗MalfunctionSep 21, 2026Failure to Fold
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the lens wouldn't load properly after multiple attempts.Additional information has been requested but is not available at the time of this report
Patient problems: Insufficient Information
MAUDE report 50840075 ↗MalfunctionMay 5, 2026Material Deformation
THIS REPORT INVOLVES THREE PATIENTS. THIS MEDICAL DEVICE REPORT SPECIFICALLY PERTAINS TO THE RIGHT EYE OF THE 2ND PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25083434 ↗MalfunctionApr 30, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE LENS TRAILING HAPTIC DIDN'T FOLD CORRECTLY DURING LOADING. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25045941 ↗MalfunctionApr 3, 2026Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION, THE IMPLANT REMAINED STUCK IN THE PLUNGER. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING A BACKUP LENS OF SAME MODEL AND DIOPTER.
Patient problems: Insufficient Information
MAUDE report 24777303 ↗MalfunctionMar 18, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL STATED THAT THE IOL DID NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24626842 ↗MalfunctionMar 18, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT, THE CONSIGNED IOL HAD A REQUESTED LEADING HAPTIC WHEN IT WAS PREPARED. THE NURSES HAD COMPLETED ALL THE STEPS CORRECTLY, AND THE SURGEON WAS ABLE TO IMPLANT IT SAFELY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CONSIGNED IOL HAD A TWISTED LEADING HAPTIC WHEN IT WAS PREPARED. THE LENS WAS LEFT IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24624835 ↗MalfunctionMar 7, 2026Failure to Advance; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING SURGERY THE PLUNGER PASSED OVER THE INTRAOCULAR LENS (IOL), RESULTING IN DEFORMATION OF BOTH THE OPTIC AND HAPTIC COMPONENTS. THE IOL REMAINED WITHIN THE CARTRIDGE, AND THERE WAS NO CONTACT WITH THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THE IOL WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL.
Patient problems: Insufficient Information
MAUDE report 24539878 ↗MalfunctionMar 2, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PRELOAD DEVICE WAS DAMAGED FROM MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24483467 ↗MalfunctionMar 2, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PRELOAD DEVICE WAS DAMAGED FROM MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24483304 ↗MalfunctionJan 2, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE LENS DID NOT FIRE PROPERLY FROM THE PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23942492 ↗InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TOXIC ANTERIOR CHAMBER SYNDROME (TASS). THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Toxic Anterior Segment Syndrome (TASS)
MAUDE report 23932828 ↗MalfunctionDec 23, 2025Failure to Fold; Material Twisted/Bent; Failure to Fold; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING ARM HAD NOT BEEN FOLDED AT ALL. THE ARM WAS STRAIGHT FOR BOTH OF THE LENSES.
Patient problems: Insufficient Information
MAUDE report 23877775 ↗MalfunctionDec 23, 2025Failure to Fold; Material Twisted/Bent; Failure to Fold; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING ARM HAD NOT BEEN FOLDED AT ALL. THE ARM WAS STRAIGHT FOR BOTH OF THE LENSES.
Patient problems: Insufficient Information
MAUDE report 23877770 ↗MalfunctionDec 22, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS WAS PLACED IN THE PATIENTS EYE, HOWEVER THE REAR HAPTIC REMAINED STUCK ON TOP OF THE OPTIC.
Patient problems: Insufficient Information
MAUDE report 23866503 ↗MalfunctionDec 11, 2025Inaccurate Delivery; Inaccurate Delivery
A PHARMACIST REPORTED THAT, DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE MECHANISM BECAME BLOCKED, AND THE LENS COULD NOT BE IMPLANTED. THE SURGERY WAS COMPLETED USING DIFFERENT LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE IMPLANT REMAINED STUCK IN THE CORNEAL INCISION AT THE TIME OF IMPLANTATION AND NOT IN THE INJECTOR. SINCE THE SURGEON HAD TO REMOVE IT FORCEFULLY WITH TWEEZERS, HE DECIDED TO REPLACE IT WITH A NEW IMPLANT.
Patient problems: Insufficient Information
MAUDE report 23776197 ↗MalfunctionDec 10, 2025Failure to Deliver; Failure to Deliver
A NON HEALTH CARE PROFESSIONAL REPORTED THAT THE IMPLANT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23767835 ↗MalfunctionNov 19, 2025Failure to Deliver; Failure to Deliver
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS (IOL) GOT STUCK IN THE SYSTEM AND IT WAS IMPOSSIBLE TO IMPLANT THE LENS. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED USING ANOTHER IOL. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THE INJECTOR CAME IN CONTACT WITH THE PATIENT AND LENS WAS NOT INSERTED INTO THE CHAMBER.
Patient problems: Insufficient Information
MAUDE report 23595617 ↗MalfunctionNov 14, 2025Device Difficult to Setup or Prepare; Failure to Prime; Device Difficult to Setup or Prepare; Failure to Prime
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION THE LENS/HAPTIC DID NOT FOLD PROPERLY WHEN THE LEVER WAS PRESSED AND FAILED TO ADVANCE. AS A RESULT, THE LENS WAS NOT IMPLANTED DURING THE INITIAL PROCEDURE. HOWEVER, THE PROCEDURE WAS COMPLETED THE SAME DAY USING A DIFFERENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23555052 ↗MalfunctionNov 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A PHARMACIST REPORTED THAT DURING THE IMPLANT PROCEDURE, IT WAS OBSERVED THAT THE GUARD WAS OFF-CENTER AND WAS INEFFECTIVE FOR PUSHING THE IMPLANT INTO THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23496904 ↗MalfunctionOct 23, 2025Failure to Deliver; Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS DID NOT EJECT PROPERLY.
Patient problems: Insufficient Information
MAUDE report 23369508 ↗InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD EXPERIENCED BLURRY VISION, WHICH HAD RESULTED IN DIFFICULTY DRIVING AT NIGHT. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, CLINICAL REASON BEING MENTIONED AS RESIDUAL PRESCRIPTION CAUSING BLURRY VISION. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED MONOFOCAL LENS IN THE SECONDARY IMPLANT PROCEDURE.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 23366276 ↗MalfunctionSep 15, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TRAILING HAPTIC FOLDED WRONG. WHEN IOL WAS DELIVERED THE TRAILING HAPTIC STUCK ON REAR SURFACE OF OPTIC. THE HAPTIC WAS EVENTUALLY DISLODGED WITHOUT DAMAGE TO THE OPTIC. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23052571 ↗MalfunctionSep 12, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER THE IOL IS IMPLANTED INTO THE EYE THE SURGEON NOTICED SCRATCH ON THE OPTIC AND DECIDED TO EXPLANT DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23035446 ↗MalfunctionAug 11, 2025Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING LOADED, THE PLUNGER DID NOT ENGAGE THE LENS, WITH NO PATIENT CONTACT. A NEW COMPANY CARTRIDGE WAS OPENED TO LOAD THE LENS, AND THE PROXIMAL LOOP WAS BROKEN. THE PROCEDURE WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS OF THE SAME POWER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22771566 ↗
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.