Clareon™ CNA0T0 (REF CNA0T0.270)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
- 18
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00380652396479), received between Oct 22, 2021 and Mar 30, 2026 — classified as 1 injury, 17 malfunctions.
The most frequently reported specific device problem is “Failure to Eject” (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
- Failure to Eject7
- Inaccurate Delivery3
- Device Damaged by Another Device2
- Failure to Advance2
- Crack1
- Defective Component1
- Device Difficult to Setup or Prepare1
- Failure to Deliver1
Patient problems
- Insufficient Information10
- No Clinical Signs, Symptoms or Conditions7
- Eye Injury1
Recent adverse event reports
The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE DOCTOR PROCEEDED TO IMPLANT THE LENS, WHEN THE LEVER WAS PRESSED THE PLUNGER ADVANCED, BUT THE LENS DID NOT, IT BECAME STUCK AT START POINT EVEN ENOUGH VISCOELASTIC WAS USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24730023 ↗MalfunctionFeb 4, 2026Device Difficult to Setup or Prepare
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AFTER INJECTING VISCOELASTIC LOADING MODULE WAS NONFUNCTIONAL. THE IOL CAN'T BE INSERTED INTO THE CARTRIDGE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24258598 ↗MalfunctionOct 23, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE OPTIC EDGES ARE TRAPPED AT THE LIMBUS. THE LENS WAS ONLY PARTIALLY INSERTED AND AS IT WAS TRAPPED, IT WAS REMOVED AND REPLACED WITH ANOTHER LENS DURING THE SAME PROCEDURE. IT WAS REPORTED THAT THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365142 ↗MalfunctionAug 8, 2025Failure to Fold; Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN DOCTOR DEPLOYED THE LENS IT CAME FOLDED WEIRD AND WAS NOT USABLE. THERE WAS PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22750533 ↗MalfunctionAug 7, 2025Failure to Unfold or Unwrap; Failure to Unfold or Unwrap
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, NOTICED THAT THE LEADING HAPTIC WAS ADHERED TO THE OPTIC AFTER IMPLANTATION. THE SURGEON MADE SEVERAL ATTEMPTS TO SEPARATE THE HAPTIC FROM THE OPTIC BUT WAS UNSUCCESSFUL. THE SURGERY WAS COMPLETED, BUT THE IOL COULD NOT BE REPOSITIONED OR REPLACED DUE TO THE ADHESION ISSUE. AS A RESULT, THE IOL (INTRAOCULAR LENS) WAS LEFT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22737584 ↗MalfunctionJan 6, 2025Unintended Ejection; Inaccurate Delivery; Unintended Ejection; Inaccurate Delivery
A PHARMACIST REPORTED THAT DURING SURGERY THE IMPLANT EJECTED WITHOUT PRESSING THE LEVER. SO THEY HAVE USED ANOTHER LENS AND COMPLETED THE PROCEDURE. THERE WAS NO PATIENT IMPACT. ADDITIONAL INFORMATION HAS RECEIVED AND IT STATES THAT WHILE PULLING THE TRIGGER, THE IMPLANT ADVANCED AS FAR AS THE INJECTION CHAMBER, THEN RELEASED ALL PRESSURE ON THE TRIGGER, BUT THE PISTON CONTINUED ITS STROKE, EXPELLED THE IMPLANT BEFORE IT WAS POSITIONED AND READY TO BE INJECTED. IT FELL OUT AND TO AVOID COMMITTING AN ASEPTIC ERROR, WAS REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21077931 ↗MalfunctionDec 27, 2024Material Twisted/Bent; Failure to Eject; Material Twisted/Bent; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BOTH THE LENS WOULD NOT ADVANCE THROUGH THE CARTRIDGE INTO THE EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE TRAILING HAPTIC WAS STRAIGHT AND THE LENS WAS STUCK IN THE INJECTOR.
Patient problems: Insufficient Information
MAUDE report 21025816 ↗MalfunctionNov 8, 2024Failure to Advance; Failure to Eject; Failure to Advance; Failure to Eject
ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE IMPLANT WAS INJECTED, BUT IT WOULD NOT COME OUT DESPITE PERFECT PREPARATION OF THE INJECTOR. THE PLUNGER PASSED BESIDE THE IMPLANT. THE PROCEDURE WAS COMPLETE WITH ANOTHER COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 20642080 ↗MalfunctionOct 24, 2024Defective Component; Defective Component
A HEALTH CARE PROFESSIONAL REPORTED THAT BEFORE SURGERY THEY HAVE NOTICED THAT THE LENS WAS FAULTY SO IT WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20521497 ↗MalfunctionSep 2, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE SYRINGE DOES NOT PUSH THE INTRAOCULAR LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20117765 ↗MalfunctionMar 28, 2024Failure to Eject; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF THE LENS WAS STUCK IN AN INJECTOR. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 18992857 ↗MalfunctionMar 15, 2024Crack; Crack
A FACILITY REPRESENTATIVE REPORTED WITH THE DESCRIPTION OF A CRACKED INTRAOCULAR LENS (IOL). IOL WAS REMOVED DURING INITIAL PROCEDURE AND REPLACED WITH OTHER LENS. THERE WAS NO IMMEDIATE HARM. THE SURGEON¿S PROGNOSIS WAS NORMAL RECOVERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18911431 ↗MalfunctionDec 6, 2023Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE IOL INSERTION PHASE, THE PISTON WAS STUCK IN THE PISTON AND PREVENTED IT FROM EXITING. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGERY WAS COMPLETED WITH ANOTHER LENS. SAMPLE WAS NOT AVAILABLE TO RETURN.
Patient problems: Insufficient Information
MAUDE report 18273231 ↗MalfunctionOct 20, 2023Failure to Eject; Failure to Eject
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WOULD NOT ADVANCE. THERE WAS PATIENT CONTACT AND THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 17973429 ↗InjuryApr 18, 2023Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DOES NOT ENTER THE INCISION PRECISELY, SO THE LENS CAME OUT BADLY. THEN WITH THE OTHER DEVICE THEY ENLARGED THE INCISION AND IT WAS FINE.
Patient problems: Eye Injury
MAUDE report 16761268 ↗MalfunctionJan 27, 2022Inaccurate Delivery; Inaccurate Delivery
A PHARMACIST REPORTED THAT DURING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INTRAOCULAR LENS (IOL) CAME OUT OF THE PATIENT¿S EYE AT THE TIME OF THE INJECTION. THE INCIDENT OCCURRED DURING THE IMPLANT INTRODUCTION INTO THE PATIENT'S EYE. THE DEVICE TOUCHED THE PATIENT'S EYE. ANOTHER IMPLANT WAS USED. THERE WERE NO CLINICAL CONSEQUENCES OBSERVED FOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13363778 ↗MalfunctionNov 3, 2021Failure to Advance; Device Damaged by Another Device; Failure to Advance; Device Damaged by Another Device
A PHYSICIAN REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE INJECTOR WENT PASS THE LENS AND THE LENS HAD TO BE INSERTED MANUALLY, THE SURGEON HAD TO BREAK THE INJECTOR TO GET THE LENS BUT THE SURGEON REALIZED THAT THE LENS WAS DAMAGED AND REPLACED IT WITH ANOTHER LENS. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12746493 ↗MalfunctionOct 22, 2021Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT SURGERY, THE IOL FOUND TO BE BROKEN IN THE CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, FURTHER INFORMATION HAS NOT BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12683916 ↗
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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