Clareon™ CNA0T0 (REF CNA0T0.205)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 artificial lens is implanted in the eye during cataract surgery and loaded with a pre-loaded injector. Many of the 112 reports describe the lens or its arms folding wrong, sticking in the injector, or failing to eject or unfold during surgery. The reports include 5 injuries and no deaths, and 3 list a tear in the capsular bag, the thin membrane that holds the lens. 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
- 110
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 00380652393720), received between Sep 2, 2021 and Sep 16, 2026 — classified as 5 injuries, 105 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare19
- Failure to Advance19
- Device Damaged by Another Device13
- Failure to Eject12
- Failure to Deliver11
- Failure to Unfold or Unwrap10
- Defective Device8
- Material Twisted/Bent7
Patient problems
- Insufficient Information66
- No Clinical Signs, Symptoms or Conditions41
- Capsular Bag Tear3
- Blurred Vision2
- Visual Disturbances2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Edema1
Recent adverse event reports
The 25 most recent of 110 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Device Damaged by Another Device
A physician reported that, during an intraocular lens (IOL) implantation procedure, after implantation a scratch was noticed on the surface of the lens. Therefore, the lens was cut in half using scissors and explanted (removed).Additional information has been requested and received it states that implanted the IOL into the eye in the usual manner. At the moment the IOL unfolded (and the optic could be seen in its entirety), a small tear became visible at the edge of the optic. To allow for immediate explantation, physician divided the IOL into two halves with scissors and then removed both halves from the eye. Subsequently, the surgeon was able to implant a new IOL of the same type without any harm to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50788448 ↗MalfunctionMay 25, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC DID NOT ENGAGE. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25270736 ↗MalfunctionMay 14, 2026Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IMPLANT WAS DEFECTIVE AND WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25171059 ↗MalfunctionMay 11, 2026Material Deformation
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A GLISTENING IN THE IOL. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT 3. THIS FILE IS FOR LEFT EYE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25135464 ↗MalfunctionMay 6, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS WAS OBSERVED TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE HAPTIC WAS DEFECTIVE/KINKED DURING PRIMING, AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096029 ↗MalfunctionApr 27, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, THE SURGEON NOTED THAT THE TRAILING HAPTIC WAS STUCK IN THE INJECTOR TIP. THE SURGEON ATTRIBUTED THIS ISSUE TO MANUFACTURING DEFECT. THE SURGERY WAS COMPLETED ON THE SAME DAY BY REMOVING THE LENS IN AN INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999684 ↗MalfunctionApr 24, 2026Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A DEFECTIVE OPENING IN THE CARTRIDGE, WHICH PREVENTED THE LENS FROM DEPLOYING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24983322 ↗MalfunctionApr 24, 2026Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PLUNGER WAS DEFECTIVE. WHEN THE SURGEON ADVANCED THE PLUNGER, IT MOVED OFF-AXIS AND DEVIATED TO THE LEFT AROUND THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24979799 ↗MalfunctionApr 24, 2026Device Difficult to Setup or Prepare
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE HAPTIC OF THE LENS MALFUNCTIONED WHEN THE SURGEON STARTED TO DEPLOY THE LENS AND THE PHYSICIAN IMMEDIATELY STOPPED TO ADVANCE THE LENS AND A REPLACEMENT LENS WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24976596 ↗MalfunctionApr 15, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, THE LENS FAILED TO DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24884562 ↗MalfunctionApr 8, 2026Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IOL INJECTOR MISS POSITIONED THE LENS INTO THE NARROW PART OF THE CARTRIDGE, RESULTING IN ENTRAPMENT, DEFORMATION AND DETACHMENT OF THE POSTERIOR HAPTIC AS THE LENS EXITED THE DEVICE. THE IOL ENTERED THE CAPSULAR BAG WITH ONLY ONE HAPTIC. THE LENS WAS EXPLANTED AND REPLACED WITH AN IDENTICAL IOL OF THE SAME DIOPTER POWER. THE PROCEDURE WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM WAS REPORTED. PATIENT CURRENT CONDITION WAS SATISFACTORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24818731 ↗MalfunctionApr 6, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE TRAILING HAPTIC FOLDED THE OTHER WAY. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24789567 ↗MalfunctionMar 26, 2026Device Difficult to Setup or Prepare; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THEY FOUND OUT THE LENS WAS FAULTY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24702410 ↗MalfunctionMar 25, 2026Failure to Prime; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING PHACOEMULSIFICATION PROCEDURE INVOLVING INTRAOCULAR LENS (IOL) IMPLANTATION, THE DEVICE PLUNGER INCORRECTLY POSITIONED THE LENS IN THE NARROW PART OF THE CARTRIDGE, WHICH LED TO ENTRAPMENT, DEFORMATION, AND DETACHMENT OF THE IOL HAPTIC ELEMENT AS IT EXITED THE DEVICE. THERE WERE NO PATIENT CONTACT AND NO PATIENT HARM. THE SURGERY WAS COMPLETED USING A SIMILAR LENS OF THE SAME DIOPTER POWER ON SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24687649 ↗MalfunctionMar 25, 2026Break; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED BROKEN DISTAL LOOP. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24687305 ↗MalfunctionMar 24, 2026Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN DEVICE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24672614 ↗MalfunctionMar 17, 2026Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED THAT, THE LENS STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24614872 ↗MalfunctionMar 13, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE CARTRIDGE WAS FOUND TO BE FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24591399 ↗MalfunctionMar 5, 2026Break
A MATERIALS MANAGER REPORTED AN ISSUE THAT OCCURRED DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE. A PIECE OF BLUE PLASTIC WAS FOUND ATTACHED TO THE LEADING HAPTIC OF THE LENS. THE SURGERY WAS COMPLETED ON SAME DAY BY REMOVING THE BLUE PLASTIC FROM THE EYE. BASED ON NEW INFORMATION RECEIVED AFTER FOLLOW-UP FROM THE REPORTER, THE SURGEON STATED THAT THE BLUE PLASTIC PIECE MATCHED THE BLUE ON THE INJECTOR, SO IT MAY HAVE ORIGINATED FROM THE INJECTOR. THE LENS REMAINS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 24518745 ↗MalfunctionFeb 18, 2026Failure to Unfold or Unwrap
A FACILITY REPRESENTATIVE REPORTED STATING THAT THE LENS WAS DEFECTIVE, SURGEON STATED IT UNFOLDED WEIRD. ADDITIONAL INFORMATION HAD BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24377608 ↗MalfunctionFeb 17, 2026Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THERE WAS PROBLEM WITH LOADING THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24364372 ↗MalfunctionFeb 5, 2026Failure to Advance
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT PLUNGER BYPASSED THE IOL AND IT WAS NOT ABLE TO BE DISCHARGED FROM THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 24275082 ↗MalfunctionFeb 5, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE HAPTIC WAS BENT, WITH NO PATIENT CONTACT. 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 24267714 ↗MalfunctionFeb 2, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) WAS DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24234187 ↗MalfunctionJan 16, 2026Failure to Advance
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE PLUNGER OVERRODE THE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24091894 ↗
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 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.