Clareon™ CNA0T0 (REF CNA0T0.225)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 intraocular lens, a preloaded lens placed in the eye during cataract surgery, has 115 adverse event reports on file. Many describe the preloaded injector failing to eject or advance the lens, or the lens being bent or damaged, and some describe lenses breaking inside the plunger. The reports include no deaths and 9 injuries, and 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
- 113
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 00380652393768), received between Oct 5, 2021 and Sep 28, 2026 — classified as 9 injuries, 104 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (26 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 Prepare26
- Failure to Eject19
- Failure to Advance13
- Material Twisted/Bent12
- Device Damaged by Another Device11
- Failure to Deliver10
- Adverse Event Without Identified Device or Use Problem7
- Failure to Fold6
Patient problems
- Insufficient Information58
- No Clinical Signs, Symptoms or Conditions49
- Blurred Vision3
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Capsular Bag Tear1
- Halo1
- Intraocular Pressure Increased1
Recent adverse event reports
The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Advance; Device Damaged by Another Device
A health care professional reported that before the intraocular lens (IOL) implantation surgery, during priming, the lens did not advance, and the plunger bypassed the lens and the lens broke.Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50913035 ↗MalfunctionSep 25, 2026Failure to Deliver
A Non health care professional reported that, during intraocular lens implantation surgery, Lens was not injected out of injector properly and the procedure completed on same day and there was no patient harm.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 50893366 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
A non-health care professional reported that following an intraocular lens (IOL) implantation procedure, the lens was explanted. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50787845 ↗MalfunctionSep 15, 2026Failure to Deliver
A Pharmacy technician reported that during surgery, it was observed that the intraocular lens (IOL) was stuck in the injector.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50772847 ↗MalfunctionSep 11, 2026Failure to Fold
A facility representative reported with a description of lens would not load correctly.Additional information has been requested.
Patient problems: Insufficient Information
MAUDE report 50730573 ↗MalfunctionAug 31, 2026Dent in Material
Patient problems: Insufficient Information
MAUDE report 50522196 ↗MalfunctionAug 25, 2026Device Difficult to Setup or Prepare
A physician reported that during an intraocular lens (IOL) implantation procedure, trailing haptic got stucked between plunger and wall of injector.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50435331 ↗MalfunctionJul 17, 2026Device Difficult to Setup or Prepare
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PRE-LOAD DEVICE WAS MALFUNCTIONED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25853289 ↗MalfunctionJul 14, 2026Failure to Advance
Patient problems: Insufficient Information
MAUDE report 25812584 ↗MalfunctionJun 5, 2026Failure to Fold; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS LOADING ERROR, HAPTIC JAMMED OR DAMAGED IN DELIVERY SYSTEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25410001 ↗MalfunctionMay 11, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING PRIMING OF THE DEVICE FOR AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE TRAILING HAPTIC WAS FOLDED WRONG. THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS 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 25137420 ↗MalfunctionMay 6, 2026Device Difficult to Setup or Prepare
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS HAPTICS OF THE LENS DID NOT DEPLOY CORRECTLY 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 25107853 ↗InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE LENS WAS INSERTED, SURGEON BEGAN TO NOTICE SOME FOLDS THAT SURPRISED. AS THE SURGEON FOLLOWED THE FOLDS, IT WAS NOTICED THAT THE LENS HAD RUPTURED THE CAPSULE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Capsular Bag Tear
MAUDE report 25070345 ↗MalfunctionApr 30, 2026Device Difficult to Setup or Prepare; Failure to Prime; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 25048745 ↗MalfunctionApr 13, 2026Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION OF IMPLANT GOT STUCK IN THE INJECTOR.
Patient problems: Insufficient Information
MAUDE report 24853490 ↗MalfunctionApr 9, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC FOLDED WRONG. THE PROCEDURE COMPLETED THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24831878 ↗MalfunctionApr 7, 2026Device Difficult to Setup or Prepare
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT TRAILING HAPTIC FOLDED WRONG DURING LOADING. THERE WAS NO PATIENT CONTACT AND PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24801962 ↗MalfunctionMar 18, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL STATED THAT THE IOL DID NOT ADVANCE INTO THE CARTRIDGE. THEY STATED IT OCCURS FREQUENTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24629753 ↗MalfunctionMar 5, 2026Device Difficult to Setup or Prepare
A PHARMACIST REPORTED THAT REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC BLOCKED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24518761 ↗MalfunctionMar 2, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24491633 ↗MalfunctionFeb 13, 2026Material Twisted/Bent
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC WAS TWISTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT
Patient problems: Insufficient Information
MAUDE report 24331374 ↗MalfunctionJan 27, 2026Product Quality Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A DEFECTIVE PRELOADED DEVICE WAS OBSERVED. IT WAS NOT IMPLANTED AND WAS DESTROYED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24188889 ↗MalfunctionJan 17, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED A TRAILING HAPTIC WHICH WAS FOLDED WRONG. THEY ALSO STATED TRAILING HAPTIC WAS STRAIGHT, FAILED TO ENGAGE. ADDITIONAL INFORMATION RECEIVED STATING THAT EVENT NOTICED DURING LOADING AND THERE WAS NO PATIENT CONTACT. THE SCHEDULED PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24105480 ↗MalfunctionJan 16, 2026Device Difficult to Setup or Prepare; Dent in Material
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, OBSERVED CENTRAL PITTING AND NOTCH IN TRAILING HAPTIC. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24095319 ↗MalfunctionJan 12, 2026Material Twisted/Bent
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS TRAILING HAPTIC DIDN'T LOAD, HAPTIC WAS STRAIGHT, NOT CURVED. THERE WAS NO PATIENT CONTACT, AND THE PROCEDURE WAS COMPLETED SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24036602 ↗
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 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
- 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.