Clareon™ CNA0T0 (REF CNA0T0.235)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 multifocal intraocular lens, sold with a preloaded delivery system, has 85 adverse event reports: 81 malfunctions and 4 injuries, with no deaths. The reports mostly describe the lens failing to eject or advance from the preloaded injector, difficult setup, and haptics folding in the wrong place. 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
- 88
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 88 adverse event reports that list this exact device (DI 00380652393782), received between Oct 26, 2021 and Sep 24, 2026 — classified as 4 injuries, 84 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (20 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 Prepare20
- Failure to Eject16
- Device Damaged by Another Device11
- Failure to Advance11
- Failure to Deliver10
- Break6
- Defective Device5
- Material Twisted/Bent5
Patient problems
- Insufficient Information49
- No Clinical Signs, Symptoms or Conditions38
- Corneal Edema2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Capsular Bag Tear1
- Eye Pain1
- Intraocular Pressure Increased1
Recent adverse event reports
The 25 most recent of 88 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Deformation
A physician reported that subsurface nano glistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been requested and received there has been no visual impact to patient.There are multiple medical reports associated with same event. this file is 20 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884737 ↗MalfunctionSep 24, 2026Material Deformation
A physician reported that subsurface nano glistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been requested but no information is available at the time of this report.There are multiple medical reports associated with same event. This file is 8 of 29.
Patient problems: Insufficient Information
MAUDE report 50883846 ↗MalfunctionSep 21, 2026Failure to Deliver; Device Damaged by Another Device
A healthcare professional reported that during an intraocular lens (IOL) implantation procedure, they were unable to push the lens through, resulting in damage to the optic.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50840851 ↗MalfunctionSep 21, 2026Device Difficult to Setup or Prepare; Inaccurate Delivery
A healthcare professional reported with a description of the haptic was loaded and injected; while pushing it from side to side, the IOL tipped.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50840313 ↗MalfunctionSep 21, 2026Failure to Unfold or Unwrap
A non-healthcare professional reported that during an intraocular lens (IOL) implantation procedure, the leading haptic folded behind the intraocular lens. The procedure was completed on the same day.Additional information has been requested.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840312 ↗MalfunctionSep 21, 2026Failure to Deliver
A non-health care professional reported that during an intraocular lens (IOL) implant procedure, the lens failure to deploy.Additional information has been requested and received stating that the issue occurred during insertion and a replacement lens was used to complete the surgery. There was patient contact and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840076 ↗MalfunctionAug 13, 2026Device Difficult to Setup or Prepare
Patient problems: Insufficient Information
MAUDE report 50232317 ↗MalfunctionJul 11, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTIC DID NOT LOAD PROPERLY. THE PROCEDURE COMPLETED THE SAME DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25790193 ↗MalfunctionMay 13, 2026Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS OPTICS CRACKED AND TORN, IT IS REPLACED WITH NEW PRODUCT AND COMPLETED SURGERY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25163942 ↗MalfunctionApr 30, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION IN PATIENT'S RIGHT EYE, THE DEVICE MALFUNCTIONED DURING INSERTION. THE LENS WAS NOT INSERTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25043539 ↗MalfunctionApr 24, 2026Device Difficult to Setup or Prepare; Failure to Prime; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING PRIMING OF THE DEVICE, IT WAS NOTED THAT THE HAPTIC WAS AT THE WRONG ANGLE FOR THE LENS TO RELEASE. AS A RESULT, WHEN TRYING TO RELEASE THE LENS THE HAPTIC DID NOT RELEASE THE LENS APPROPRIATELY AND WAS OFF KILTER. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THERE WAS NO PATIENT CONTACT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, WHEN THE TECHNICIAN WAS PRIMING THE LENS TO HAND TO THE SURGEON, IT WAS NOTED THAT THE LENS PUSHER WENT TO THE SIDE AND STARTED TO BEND. THE LENS WAS DISPOSED OF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24977125 ↗MalfunctionApr 14, 2026Break; Device Damaged by Another Device
A PHARMACIST REPORTED THAT BEFORE THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IMPLANT WAS FOUND TO BE DEFECTIVE AND WAS BROKEN IN SEVERAL AREAS, THE AREA WHERE THE VISCOELASTIC WAS INJECTED WAS BROKEN. THE TIP OF THE CARTRIDGE WAS BROKEN AND CRACKED, MAKING IT IMPOSSIBLE TO INJECT THE IMPLANT. HENCE IT WAS NOT IMPLANTED AND A REPLACEMENT LENS WAS IMPLANTED SUCCESSFULLY.
Patient problems: Insufficient Information
MAUDE report 24875526 ↗MalfunctionApr 13, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE FRONT HAPTIC CAME OUT COMPLETELY DISPLACED FORWARD (IT DID NOT COME OUT OVER THE LENS). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24857020 ↗MalfunctionApr 11, 2026Failure to Advance
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER DID NOT ENGAGE, OVERRODE THE LENS. UNKNOWN IF ANY PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24852062 ↗MalfunctionApr 6, 2026Device Difficult to Setup or Prepare; Failure to Advance
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE IOL¿S TRAILING HAPTIC FOLDED WRONG. THE REPORTER ALSO STATED SURGEON NOTED TRAILING HAPTIC CAUGHT ON PLUNGER. ENOUGH OPHTHALMIC VISCOSURGICAL DEVICES (OVD) WAS USED TO FILL THE AUTO INJECTOR. IT WAS ROOM IN TEMPERATURE. THE LENS WAS HANDED TO THE SURGEON WITHIN A MINUTE OF LOADING THE INJECTOR. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED AND STATED THAT. THE ISSUE WAS NOTED AS THE SURGEON WAS PRELOADING PRIOR TO PATIENT CONTACT. THE PLUNGER ADVANCE ON TOP OF TRAILING HAPTIC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789780 ↗MalfunctionMar 25, 2026Inaccurate Delivery
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, WHILE PLACING THE IOL, THE MECHANISM PASSED STRAIGHT THROUGH. EVEN AFTER THEY REMOVED THEIR HAND, THE DEVICE DID NOT STOP. SINCE THE CLINIC HAD ANOTHER IOL AVAILABLE, THE SURGERY WAS COMPLETED NORMALLY AND DID NOT CAUSE ANY HARM TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY. 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 24687300 ↗MalfunctionMar 16, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC WAS STUCK. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24605372 ↗MalfunctionMar 10, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THE LENS DID NOT EJECT PROPERLY. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION WAS REQUESTED, YET NO NEW INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24559625 ↗MalfunctionFeb 27, 2026Failure to Deliver
A PHARMACIST REPORTED WITH A DESCRIPTION OF IMPLANT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24470365 ↗MalfunctionFeb 20, 2026Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION, LENS THAT BECAME STUCK IN THE INJECTOR AND SECOND HALF/TRAILING HAPTIC STUCK IN THE CARTRIDGE. IT WAS ALSO STATED THAT THE SURGERY WAS COMPLETED USING THE SAME IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24399874 ↗MalfunctionFeb 18, 2026Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED THAT DURING INTRAOCULAR LENS IMPLANT PROCEDURE WITH THE DESCRIPTION OF FAULTY INJECTOR. ADDITIONAL INFORMATION HAS BEEN RECIEVED AND STATED THAT THE LEADING HAPTIC LOOKED WEIRD WHEN ADVANCING. IT WAS ALSO STATED THAT THE TIP OF INJECTOR DID NOT COME IN CONTACT WITH THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24376505 ↗MalfunctionFeb 9, 2026Failure to Deliver; Material Twisted/Bent
BASED ON ADDITIONAL INFORMATION RECEIVED, THE REPORTED EVENT "PRELOADED DEVICE DID NOT DELIVER THE LENS" WAS FURTHER DETAILED: THE DEVICE DID NOT DEPLOY THE LENS AS THE HAPTIC WAS TWISTED. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24291075 ↗MalfunctionJan 7, 2026Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS STUCK AND DID NOT DELIVER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23988118 ↗MalfunctionJan 2, 2026Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LEADING HAPTIC OF THE LENS WAS SHEARED OFF. SUBSEQUENTLY THE LENS WAS REMOVED DURING INITIAL PROCEDURE.
Patient problems: Insufficient Information
MAUDE report 23943367 ↗MalfunctionDec 11, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NURSE REPORTED THAT A DEFECT WAS FOUND IN THE LENS HAPTIC PART BEFORE SURGERY. THEREFORE, THE LENS WAS REPLACED WITH ANOTHER ONE AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONTACT AND NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23777038 ↗
Other Lens, multifocal intraocular devices
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.