Clareon™ CNA0T0 (REF CNA0T0.265)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
- 21
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652396462), received between Aug 1, 2022 and Aug 26, 2026 — classified as 1 injury, 20 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (5 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 Deliver5
- Failure to Eject5
- Defective Device3
- Device Difficult to Setup or Prepare3
- Failure to Advance3
- Inaccurate Delivery2
- Adverse Event Without Identified Device or Use Problem1
- Device Damaged by Another Device1
Patient problems
- Insufficient Information12
- No Clinical Signs, Symptoms or Conditions8
- Blurred Vision1
- Visual Disturbances1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 26, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported during intraocular lens (IOL) implant procedure, the haptic came out straight.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50456702 ↗MalfunctionJul 10, 2026Failure to Deliver
Patient problems: Insufficient Information
MAUDE report 25778712 ↗MalfunctionMay 7, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT DEPLOY FROM THE INJECTOR AS EXPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25108562 ↗MalfunctionFeb 11, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS FAULTY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24316115 ↗MalfunctionJan 12, 2026Device Difficult to Setup or Prepare; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, FAILURE TO EJECT, HAPTIC DAMAGED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24040457 ↗MalfunctionNov 28, 2025Material Twisted/Bent; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAPTIC BENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23671209 ↗MalfunctionAug 25, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE SURGEON WAS UNABLE TO USE THE LENS AS THE DELIVERY WAS CONTINUOUS DESPITE REMOVING FINGER FROM THE BUTTON. HENCE A BACK UP LENS WAS USED TO COMPLETE THE SURGERY. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE LENS CONTINUED TO BE DELIVERED ONCE IT REACHED THE REST POSITION EVEN THOUGH THE CONTROL BUTTON WAS RELEASED. THIS WAS POSITIONED WITH A VIEW THROUGH THE MICROSCOPE. THE SAME LENS WAS USED FOR THE PREVIOUS OPERATION WITH NO PROBLEMS. THE VISCOELASTIC HAD BEEN BROUGHT TO ROOM TEMPERATURE AND WAS OUT OF THE FRIDGE FOR AN HOUR IN THEATRE.
Patient problems: Insufficient Information
MAUDE report 22884891 ↗MalfunctionAug 18, 2025Failure to Deliver; Failure to Deliver
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS FAILED TO DEPLOY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22828581 ↗MalfunctionMay 14, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, REPORTED LENS CAME OUT BUT STUCK TO THE END OF THE LENS APPLICATOR. WHEN THE APPLICATOR WAS PULLED OUT OF THE EYE THE LENS CAME WITH IT. IN THE SURGEON OPINION DEFECTIVE APPLICATOR CAUSED OR CONTRIBUTED TO THE EVENT. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22018473 ↗InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT RIGHT EYE STARTED TO HAVE A NEEDLE IN EYE BUT AT 2:40 AM. THE PATIENT STARTED TO SEE AN "X" IN EACH LUMINOUS POINT, WHICH PERSISTS TO THIS DAY ON (B)(6) 2024). THIS WAS VERY DISTURBING, AND I NEVER DROVE AT NIGHT AGAIN. HOWEVER, DOING TESTS TODAY ON (B)(6) 2024) IN SUNLIGHT, THE PATIENT NOTICED THAT THE PROBLEM HAS DECREASED. EVEN UNDER GOOD LIGHTING, THE LIGHT COLOR NO LONGER "POPS" AND PATIENT STARTED TO SEE THE WHITE LESS BLUISH AND CLOSER TO THE WHITE REALLY. IN THE LENS OF THE RIGHT EYE THIS DID NOT OCCUR. THE OPHTHALMOLOGIST ASKED FOR THE LENSES TO BE ZEROED AWAY. ON THE RIGHT, PATIENT SEE BETTER UP CLOSE AND WORSE FAR AWAY. THE PATIENT NOTICE THAT THERE WAS A SMALL DELAY FOR ADJUSTING THE VISION, WHEN THERE WAS A RAPID VARIATION OF FOCUS (FAR/NEAR OR LEFT/RIGHT). THE PATIENT BELIEVED THIS IS NORMAL BECAUSE NOTHING FULLY REPLACES THE LENS. THE PATIENT ALSO STATED, DO NOT KNOW IF THE BRAIN WILL CORRECT THIS OVER TIME.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 20680775 ↗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 20642230 ↗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 20642127 ↗MalfunctionNov 5, 2024Failure to Fold; Failure to Eject; Failure to Fold; Failure to Eject
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF PLUNGER OVER INTRAOCULAR LENS (IOL) AND FOLDING ISSUES. THERE WAS NO PATIENT SAFETY CONCERN. THE FRONT OPENING WHERE THE LENS WAS INJECTED THROUGH WAS MISHAPPEN COMING OUT OF THE PACKAGE. THE SURGERY PROCEEDED AS PER NORMAL WITH THE BACK UP LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612908 ↗MalfunctionJun 12, 2024Difficult to Advance; Difficult to Advance
A PHYSICIAN REPORTED THAT NOTICED INJECTION DEFECT. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19520572 ↗MalfunctionMar 25, 2024Device Damaged by Another Device; Device Damaged by Another Device
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS DAMAGED AT THE PERIPHERY OF OPTICS ZONE. DAMAGE WAS NOTICED BY SURGEON UNDER MICROSCOPE DURING VISCOELASTIC REMOVAL. THE DAMAGE WAS NOTICED AFTER THE IMPLANTATION OF IOL IN THE EYE. ADDITIONAL INFORMATION HAS BEEN RECEIVED, NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18968197 ↗MalfunctionFeb 5, 2024Defective Device; Defective Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THE INJECTION DEFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18638998 ↗MalfunctionOct 16, 2023Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, LENS WOULD NOT LOAD INTO PATIENTS EYE CORRECTLY. THE PROCEDURE WAS COMPLETED SAME DAY WITH SAME MODEL AND DIOPTER. ADDITIONAL INFORMATION RECEIVED AND STATED THAT, THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17939325 ↗MalfunctionSep 21, 2023Inaccurate Delivery; Defective Device; Inaccurate Delivery; Defective Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE INJECTOR TIP WAS ROUGH AND THE LENS WAS MISPLACED IN THE CAPSULAR BAG. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS IN THE SAME PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THERE WAS NO PATIENT HARM AND THE PATIENT IS RECOVERING HIS VISION WITHOUT MAJOR INCONVENIENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17789952 ↗MalfunctionJul 18, 2023Failure to Eject; Failure to Eject
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, IT WAS REPORTED THAT LENS DEPLOYED PREMATURELY AND PATIENT CONTACT WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 17340964 ↗MalfunctionOct 21, 2022Defective Device; Defective Device
A NURSE REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) NOT COOPERATING DURING THE PROCEDURE. THERE WAS A PATIENT CONTACT NOTED. THERE WAS NO PATIENT HARM REPORTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER IOL DURING INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15650186 ↗MalfunctionAug 1, 2022Failure to Advance; Failure to Advance
A PHYSICIAN REPORTED THAT, DURING CATARACT PHACOEMULSIFICATION SURGERY WITH IOL IMPLANT, WHILE PRESSING THE LEVER, THE PUSHER ADVANCED AND IT WAS CONTINUING TO MOVE, THE LENS DID NOT COME OUT OF THE CARTRIDGE - IT REMAINED IN THE CARTRIDGE. THERE WAS PATIENT CONTACT, HOWEVER NO PATIENT HARM. THE SURGERY WAS COMPLETED USING A REPLACEMENT LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15139503 ↗
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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