Clareon™ CNA0T0 (REF CNA0T0.240)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon CNA0T0 is a pre-loaded aspheric hydrophobic acrylic lens used in cataract surgery to replace the eye's natural lens. The 66 reports mostly describe the lens failing to come out of its injector cartridge during surgery — stuck, torn, sideways-moving, scratched, or not unfolding — with a few mentions of a torn capsule and vision changes. There are 5 injuries and no deaths. One recall, started in May 2022 and closed, involved mix-ups in product labeling from overlapping manufacturing runs.
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
- 66
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 00380652393799), received between Oct 22, 2021 and Sep 23, 2026 — classified as 5 injuries, 61 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (17 reports).
1 FDA recall record name this device's identifier.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- May 11, 2022Terminated
Due to device (preloaded intraocular lens) mislabeling, associated with partial mixing of product during overlapping manufacturing runs, and attributed to improper manufacturing line clearance.
Z-1269-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Advance17
- Device Difficult to Setup or Prepare10
- Device Damaged by Another Device8
- Failure to Deliver6
- Failure to Eject6
- Failure to Unfold or Unwrap4
- Adverse Event Without Identified Device or Use Problem3
- Break3
Patient problems
- Insufficient Information38
- No Clinical Signs, Symptoms or Conditions23
- Capsular Bag Tear2
- Visual Impairment2
- Blurred Vision1
- Corneal Abrasion1
- Visual Disturbances1
Recent adverse event reports
The 25 most recent of 66 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Failure to Advance; Device Damaged by Another Device
A Non-Healthcare Professional reported during intraocular lens (IOL) implant procedure, the injector faulty and lens was damaged by injector.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50865461 ↗MalfunctionSep 22, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.There are two medical reports associated with this patient. This file belongs to right eye.Additional information has been requested and received by stating there was no visual impact to the patient.There are multiple medical reports associated with same event. This file is 12 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853454 ↗MalfunctionAug 27, 2026Failure to Advance; Device Damaged by Another Device
A physician reported that, during an intraocular lens (IOL) implantation surgery, the IOL plunger was improperly positioned, resulting in entrapment and deformation of the IOL in the narrow section of the cartridge, with no patient contact. Company viscoelastic was used to prepare the system for IOL implantation. Appropriate storage conditions and temperature requirements were maintained. The procedure was completed on the same day.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50471313 ↗MalfunctionJun 22, 2026Failure to Advance; Scratched Material
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PLUNGER OVERRIDE OVER THE LENS DUE TO THIS, SCRATCHES SEEN ON LENS SURFACE. THE PROCEDURE WAS COMPLETED ON SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 25589034 ↗MalfunctionJun 18, 2026Failure to Advance; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY WHILE THE IOL BEING INSERTED INTO THE PATIENT EYE THE PLUNGER OVERRIDE AND RESULTED, THE SCRATCH ON LENS WITH PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION RECEIVED STATING THE EVENT OCCURRED WHILE INJECTING IN THE EYE. THE SURGERY WAS COMPLETED AND THE SAME LENS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 25552159 ↗MalfunctionJun 17, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT REMAINED STUCK IN THE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, THE SURGERY WAS COMPLETED ON THE SAME DAY BY USING A REPLACEMENT IMPLANT.
Patient problems: Insufficient Information
MAUDE report 25533162 ↗InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED AFTER INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS PLACED BUT REMOVED DUE TO POSTERIOR TEAR AFTER INSERTION OF THE LENS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Capsular Bag Tear
MAUDE report 25242674 ↗MalfunctionMay 7, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT THE PATIENT UNDERWENT CATARACT SURGERY. BEFORE THE SURGERY, IT WAS OBSERVED THAT THE PRODUCT BROKE, AND THERE WAS NO PATIENT CONTACT. 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 25119725 ↗MalfunctionApr 27, 2026Device Damaged by Another Device; Device Dislodged or Dislocated
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE TIME OF THE LENS IMPLANT THE LENS WAS TRAPPED IN THE INCISION. THE LENS WAS REMOVED AND CHECKED IF IT WAS POSSIBLE TO IMPLANT AGAIN BUT A MARK WAS OBSERVED ON THE OPTIC. SO, THE DOCTOR DECIDED TO CHANGE IT AND A NEW WAS IMPLANTED TO COMPLETE THE PROCEDURE ON THE SAME DAY. THERE WAS NO HARM TO THE PATIENT. 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 24998910 ↗MalfunctionApr 24, 2026Device Difficult to Setup or Prepare; Failure to Advance
A PHARMACIST REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING INVENTORY, THE SALES REPRESENTATIVE NOTED THAT TWO PRELOAD DEVICES WERE SET ASIDE BECAUSE THEY WERE DEFECTIVE. SHE INDICATED THAT THE PISTON USED TO PROPEL THE IMPLANT INTO THE CARTRIDGE WAS NOT ALIGNED THEREFORE, IT WAS NOT POSSIBLE TO LOAD THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24983069 ↗MalfunctionApr 24, 2026Device Difficult to Setup or Prepare; Failure to Advance
A PHARMACIST REPORTED THAT DURING A CATARACT SURGERY WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING INVENTORY, THE SALES REPRESENTATIVE NOTED THAT TWO PRELOAD DEVICES WERE SET ASIDE BECAUSE THEY WERE DEFECTIVE. SHE INDICATED THAT THE PISTON USED TO PROPEL THE IMPLANT INTO THE CARTRIDGE WAS NOT ALIGNED THEREFORE, IT WAS NOT POSSIBLE TO LOAD THE IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24982995 ↗MalfunctionApr 11, 2026Failure to Advance
A NURSE REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PLUNGER DID NOT ENGAGE AND OVERRODE THE LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24851660 ↗InjuryMar 6, 2026Failure to Unfold or Unwrap
THE EVENT REPORT FOR THIS FILE WAS RECEIVED FROM THE FRANCE HEALTH AUTHORITY. A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS IMPLANTATION SURGERY, THE HAPTIC OF THE LENS DID NOT DEPLOY CORRECTLY AND REMAINED FOLDED AND ADHERED TO THE LENS. THE PATIENT EXPERIENCED POSTERIOR CAPSULAR RUPTURE AND THE LENS WAS EXCHANGED WITH DIFFERENT MODEL OF THE COMPANY LENS AND IT WAS PLACED IN SULCUS. THE ANTERIOR VITRECTOMY SURGERY AND CORNEAL SUTURE WAS ALSO PERFORMED.
Patient problems: Capsular Bag Tear
MAUDE report 24531412 ↗MalfunctionFeb 16, 2026Device Difficult to Setup or Prepare
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE SURGEON WAS ABLE TO CUT IT BUT DID NOT REMOVE IT.
Patient problems: Insufficient Information
MAUDE report 24344036 ↗InjuryFeb 13, 2026Device Damaged by Another Device
A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENSES WERE DAMAGED COMING OUT OF THE INJECTOR. ONE OF THE LENSES WAS INJECTED IN THE EYE AND HAD TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED THAT ADDITIONAL INCISION REQUIRED AND SYMPTOMS WERE RESOLVED AND PATIENT WOUND WAS HEALING AND PROGRESSING.
Patient problems: Insufficient Information
MAUDE report 24333231 ↗MalfunctionFeb 6, 2026Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF LENS WAS DAMAGED UNDER THE INTRODUCER. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATING THAT THE EVENT OCCURRED DURING LOADING WITH NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24280030 ↗MalfunctionFeb 3, 2026Failure to Fold
A PHYSICIAN REPORTED THAT DURING UNKNOWN TIME OF AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS INCORRECTLY LOADED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24245302 ↗MalfunctionJan 28, 2026Break; Optical Decentration
A NON-HEALTHCARE PROFESSIONAL STATED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION ANTERIOR POSTERIOR TRAILING HAPTIC WAS FOUND BROKEN IN THE WOUND. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE IOL WAS SLIGHTLY DECENTERED. THE SURGERY WAS ABLE TO COMPLETE ON THE SAME DAY WITH THE IOL WAS CENTERED.
Patient problems: Insufficient Information
MAUDE report 24199562 ↗MalfunctionJan 5, 2026Failure to Advance
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE PLUNGER MOVED UNDERNEATH THE IMPLANT AS IT ADVANCED. THE SURGERY WAS COMPLETED USING ANOTHER LENS. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23960316 ↗MalfunctionDec 30, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS HAD BECOME STUCK IN THE DELIVERY SYSTEM OR CARTRIDGE, OR THE LENS WOULD NOT ADVANCE, DEPLOY, OR EJECT. THE LENS HAD BECOME STUCK AT THE TIP OF THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23920824 ↗MalfunctionDec 8, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH DESCRIPTION OF SHOOTER COULD NOT BE PUSHED FORWARD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23753061 ↗MalfunctionDec 2, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON NOTICED THAT LENS COMES WITH LEGS STRETCHED. UNSPECIFIED CLARIFIED LENS WAS USED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23693938 ↗MalfunctionDec 1, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, DURING ADVANCEMENT THE PLUNGER BYPASSED IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23679423 ↗MalfunctionNov 24, 2025Inaccurate Delivery; Material Twisted/Bent; Inaccurate Delivery; Material Twisted/Bent
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC DID NOT FOLD AND IT GOT WEDGED BETWEEN THE BLUE PLUNGER AND THE CARTRIDGE WHICH WAS STRAIGHT TRAILING HAPTIC. IT WAS ALSO STATED THAT THE LENS WAS IMPLANTED AND EXPLANTED.THE LENS AND AS A PART OF THAT HAPTIC, WAS RIPPED OFF DUE TO THE DELIVERY. ADDITIONAL INFORMATION RECIEVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633538 ↗MalfunctionOct 23, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, TRAILING HAPTIC WAS STUCKED IN THE DELIVERY SYSTEM DURING LENS ADVANCEMENT. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23367610 ↗
Other Lens, multifocal intraocular devices
- Clareon™ CNA0T0Alcon Laboratories, Inc. · Lens, multifocal intraocular144 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
- 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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