Clareon™ CNA0T0 (REF CNA0T0.230)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
Quick summary
This Alcon Clareon intraocular lens reports describe delivery and setup problems, such as lenses failing to advance, eject, or deliver, plus device damage. There are 102 reports, no deaths, 10 injuries, and 92 malfunctions. Reports rose from 24 to 34 over the last 12 months. 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
- 104
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00380652393775), received between Sep 17, 2021 and Sep 24, 2026 — classified as 10 injuries, 94 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 Advance18
- Failure to Deliver15
- Failure to Eject15
- Device Damaged by Another Device14
- Defective Device9
- Material Twisted/Bent8
- Break6
Patient problems
- Insufficient Information60
- No Clinical Signs, Symptoms or Conditions39
- Blurred Vision3
- Eye Injury3
- Inflammation2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Corneal Edema1
Recent adverse event reports
The 25 most recent of 104 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Failure to Deliver
A non-healthcare professional reported that during the intraocular lens (IOL) implantation procedure, the lens got stuck during implantation.Additional information has been received stating the lens was inserted and removed partially. There was no further impact to the patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884539 ↗MalfunctionSep 23, 2026Failure to Advance
A non-healthcare professional reported that during intraocular lens (IOL) implantation procedure, stated blue plunger went past the lens.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50867614 ↗MalfunctionAug 27, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that during an intraocular lens (IOL) implant procedure, trailing haptic folded wrong.Additional information has been requested and received stating that procedure was completed on same day and there was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50474928 ↗MalfunctionAug 6, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50159146 ↗MalfunctionJul 31, 2026Crack; Material Deformation
Patient problems: Insufficient Information
MAUDE report 50098675 ↗MalfunctionJul 31, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 50094574 ↗MalfunctionJul 14, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 25815768 ↗MalfunctionJun 15, 2026Failure to Advance
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING UNKNOWN STEP OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT ENGAGE WHEN ATTEMPTING TO LOAD IT AND WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25499781 ↗MalfunctionMay 25, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT LENS FOUND TO BE STUCK IN INJECTOR.
Patient problems: Insufficient Information
MAUDE report 25271551 ↗MalfunctionMay 18, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN INJECTOR, THE SURGERY WAS COMPLETED, AND BACKUP LENS WAS SUCCESSFULLY IMPLANTED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25200884 ↗MalfunctionApr 24, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE LENS WAS WASTED, IT DID NOT DEPLOY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24981739 ↗MalfunctionApr 4, 2026Device Difficult to Setup or Prepare; Failure to Advance
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC AND IOL WAS STUCK, IOL WAS NOT MOVED. THERE WAS NO PATIENT CONTACT WITH THE DEVICE. THE SURGERY WAS COMPLETED WITH BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24785123 ↗MalfunctionApr 1, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LENS GOT STUCK IN THE PLUNGER. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24755187 ↗MalfunctionMar 13, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DEVICE HAD BEEN DEFECTIVE AND THEREFORE WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24596644 ↗MalfunctionFeb 27, 2026Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, ONE HAPTIC REMAINED STUCK TO THE OPTIC, WHICH REQUIRED ADDITIONAL MANIPULATION. IT WAS ALSO STATED THAT THE LENS WAS IMPLANTED AND EXPLANTED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24469984 ↗MalfunctionFeb 13, 2026Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS INJECTED WITH MORE FORCE THAN USUAL. THE LENS WAS INJECTED WITH GREAT FORCE FROM THE INJECTOR THAT COULD CAUSE HARM TO PATIENT'S EYE. THE LENS WAS IMPLANTED WITH NO COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331323 ↗MalfunctionFeb 12, 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24329573 ↗MalfunctionJan 22, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEFECTIVE, WHEN THE INJECTOR WAS INSERTED INTO THE EYE, AND THAT'S WHERE THE SOLUTION DID NOT COME OUT. THE SURGERY WAS COMPLETED THE SAME DAY. THE PATIENT WAS RECOVERING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24147890 ↗MalfunctionJan 12, 2026Failure to Advance; Device Damaged by Another Device
A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT WAS PIERCED BY ITS PLUNGER, THERE WAS NO CONTACT WITH THE PATIENT, AND AN IMPLANT FROM ANOTHER SUPPLIER WAS USED INSTEAD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24049991 ↗MalfunctionJan 1, 2026Failure to Advance
A PHARMACIST REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED PLUNGER PASSES IN FRONT OF THE IMPLANT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23938939 ↗MalfunctionDec 31, 2025Failure to Advance; Failure to Advance
AN ADMINISTRATOR/SUPERVISOR REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, AT THE TIME OF ACTIVATING THE INJECTOR OF THE PRELOADED DEVICE, THE PLUNGER WENT TO ONE SIDE AND BELOW THE LENS. CONSEQUENTLY, THE PRELOADED DEVICE WAS DISASSEMBLED, AND THE IOL WAS MANUALLY IMPLANTED WITHOUT COMPLICATIONS USING A COMPANY CARTRIDGE AND INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23933613 ↗InjuryDec 29, 2025Device Difficult to Setup or Prepare; Failure to Advance; Device Difficult to Setup or Prepare; Failure to Advance
ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT WHEN LENS WAS INJECTED THE TRAILING HAPTIC WAS STUCK TO THE INJECTING DEVICE AND WAS UNABLE TO BE SEPARATED. UPON ATTEMPT TO REMOVAL OF HAPTIC THERE WAS TEMPORAL IRIS DAMAGE AND PROLAPSE. SURGEON REMOVED THE LENS BY CUTTING THE CORNEA AND PLACED SAME MODEL LENS IN THE BAG AND SUTURE TO CORNEA. THE PATIENT HAD CORNEAL EDEMA AND IRIS TIDS. THE LIGHT SENSITIVITY WAS IMPROVED BUT NOT COMPLETELY RESOLVED. CORNEAL EDEMA HAS RESOLVED. PERMANENT TIDS, VISION LIKELY TO IMPROVE WITH ARTIFICIAL TEARS DUE TO DRY EYE AND WITH GLASSES.
Patient problems: Blurred Vision; Corneal Edema; Eye Injury; Eye Pain
MAUDE report 23907933 ↗MalfunctionDec 29, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FOUND TO HAVE DEFECTIVE LOOP. HENCE COULD NOT IMPLANT THE LENS AND THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23906026 ↗MalfunctionDec 15, 2025Failure to Deliver; Inaccurate Delivery; Failure to Advance; Failure to Deliver; Inaccurate Delivery; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS DEPLOYED INCORRECTLY. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23800726 ↗MalfunctionDec 12, 2025Failure to Fold; Failure to Fold
A PHARMACIST REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE LENS WAS LOADED BADLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23789091 ↗
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 intraocular93 reports
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular88 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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