Clareon™ CNA0T0 (REF CNA0T0.160)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00380652393638), received between Nov 16, 2022 and Aug 24, 2026 — classified as 2 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (7 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 Prepare7
- Failure to Eject4
- Failure to Advance2
- Failure to Deliver2
- Failure to Fold2
- Material Twisted/Bent2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
Patient problems
- Insufficient Information14
- No Clinical Signs, Symptoms or Conditions6
- Visual Impairment1
Recent adverse event reports
The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50408913 ↗MalfunctionJun 4, 2026Failure to Advance
A OTHER HEALTH CARE PROFESSIONAL REPORTED WITH DESCRIPTION OF FAULTY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25394109 ↗MalfunctionApr 9, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF BAD LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24832811 ↗MalfunctionApr 2, 2026Device Difficult to Setup or Prepare; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS NOT MOVING FORWARD AND GOT STUCK. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING LENS HAPTIC AND IOL WERE STUCK. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THERE WAS NO EXPLANT SINCE THE LENS WAS STUCK IN THE PLUNGER. THE SURGERY WAS COMPLETED WITH BACK UP LENS. ADDITIONAL INFORMATION RECEIVED THAT THERE ARE 3 DIFFERENT SURGERIES AND DIFFERENT PATIENTS ARE GIVEN.
Patient problems: Insufficient Information
MAUDE report 24768750 ↗MalfunctionMar 17, 2026Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY NOTICED THAT THE LENS WAS TORN. SO, THE SURGERY WAS COMPLETED ON THE SAME DAY WITH ANOTHER PRODUCT WITHOUT HARMING THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24618654 ↗MalfunctionMar 6, 2026Device Difficult to Setup or Prepare
A NONHEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC STUCK IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED THAT EVENT OCCURRED DURING PRIMING AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528259 ↗MalfunctionFeb 27, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED AN ISSUE DESCRIBED AS A DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24469762 ↗MalfunctionFeb 16, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE BACK HAPTIC STUCK ON THE POSTERIOR SIDE OF THE IOL (INTRAOCULAR LENS) 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 24344627 ↗MalfunctionJan 7, 2026Material Twisted/Bent
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE HAPTIC WAS BENT. THE PRODUCT WAS REPLACED WITH A NEW ONE, AND THE SURGERY WAS COMPLETED WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988963 ↗MalfunctionNov 11, 2025Failure to Fold; Device Difficult to Setup or Prepare; Failure to Fold; Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION WAS RECEIVED AS THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23521608 ↗InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT HAD OPTICAL SURPRISE. THE IOL WAS EXCHANGED FOR UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Visual Impairment
MAUDE report 23016856 ↗MalfunctionAug 7, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING CATARACT WITH INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC WAS DAMAGED OR JAMMED IN DELIVERY SYSTEM. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22740189 ↗MalfunctionAug 6, 2025Failure to Fold; Failure to Fold
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED A MALFUNCTION OUT OF THE PACKAGE, THE LENS WOULD NOT LOAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22727515 ↗MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF IMPLANT PLACEMENT FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 21864140 ↗MalfunctionNov 11, 2024Defective Component; Failure to Advance; Material Twisted/Bent; Defective Component; Failure to Advance; Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE PLUNGER BYPASSED HAPTIC CAUSING TRAILING HAPTIC TO STRAIGHTEN AND STICK TO THE PLUNGER. ADDITIONAL INFORMATION HAS RECEIVED IT STATES THAT THE SCHEDULED PROCEDURE COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information
MAUDE report 20653733 ↗MalfunctionApr 4, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION, THE PLUNGER PASSED OVER THE IOL AND DIDN'T PUSH THE IOL PROPERLY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 19039590 ↗MalfunctionFeb 12, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED THAT, THE TIP THAT PUSHES THE LENS PASSED OVER THE LENS, LEAVING THE LENS STUCK IN THE CARTRIDGE WHICH PREVENTED THE USE OF THE LENS.
Patient problems: Insufficient Information
MAUDE report 18684469 ↗MalfunctionJan 2, 2024Defective Device; Failure to Eject; Defective Device; Failure to Eject
A OTHER HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18425996 ↗MalfunctionDec 29, 2023Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT A LENS GOT STUCK INSIDE THE INJECTOR. PATIENT DID NOT NEED ANY MEDICAL TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18417420 ↗InjuryNov 16, 2022Difficult to Advance; Difficult to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS IMPLANTATION THE LEADING HAPTIC WAS AIMING RIGHT IN A PATIENT WITH A SMALL PUPIL. THE PATIENT WAS ON FLOMAX. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 15803503 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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