Clareon™ CNA0T0 (REF CNA0T0.195)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 Clareon multifocal intraocular lens comes pre-loaded in the AutonoMe delivery system. Its 77 reports mostly describe the delivery system failing—hard to prepare, and the lens not advancing, ejecting, or delivering during surgery. There are no deaths and 7 injuries. 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
- 73
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00380652393706), received between Sep 21, 2021 and Sep 25, 2026 — classified as 7 injuries, 66 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (12 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Device Difficult to Setup or Prepare12
- Failure to Advance11
- Device Damaged by Another Device8
- Failure to Eject8
- Failure to Deliver7
- Adverse Event Without Identified Device or Use Problem5
- Defective Device5
- Break4
Patient problems
- Insufficient Information36
- No Clinical Signs, Symptoms or Conditions30
- Capsular Bag Tear2
- Visual Impairment2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Blurred Vision1
- Corneal Abrasion1
- Eye Pain1
Recent adverse event reports
The 25 most recent of 73 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information has been received and stated that there has been no visual impact to patient.There are multiple medical reports associated with same event. This file is 26 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894674 ↗MalfunctionJul 14, 2026Failure to Advance; Device Damaged by Another Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25813522 ↗MalfunctionMay 21, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE DEVICE WAS OBSERVED TO BE DEFECTIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25242673 ↗MalfunctionMay 4, 2026Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, TRAILING HAPTIC FOLDED WRONG WHEN THE IOL WAS BEING LOADED, NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25066984 ↗MalfunctionApr 16, 2026Inaccurate Delivery; Material Deformation
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY WHILE IMPLANTING THE LENS IT WAS TRAPPED IN THE INCISION AND FRACTURED. THE SURGERY WAS COMPLETED ON THE SAME DAY WITHOUT ANY PATIENT HARM. THERE WAS PATIENT CONTACT WITH THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24901947 ↗MalfunctionApr 14, 2026Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE LEADING HAPTIC HAD TWISTED. THEY ATTEMPTED TO UNTWIST IT, AFTER WHICH THE ENTIRE LENS FELL OFF THE SYSTEM. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED THERE WAS NO PATIENT CONTACT, AND THE INITIAL PROCEDURE WAS COMPLETED ON THE SAME DAY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24877629 ↗MalfunctionApr 10, 2026Failure to Prime; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE IOL (INTRAOCULAR LENS) PLUNGER INCORRECTLY POSITIONED THE LENS IN THE NARROW PART OF THE CARTRIDGE, WHICH RESULTED IN CONTACT BETWEEN THE IOL PLUNGER AND THE OPTICAL PART OF THE LENS AND DAMAGE TO THE OPTIC. THE PATIENT WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24844029 ↗MalfunctionApr 8, 2026Failure to Deliver
A PHARMACIST REPORTED THAT IMPLANT STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24824413 ↗MalfunctionMar 30, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THERE WAS AN ISSUE WITH THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24730857 ↗MalfunctionMar 5, 2026Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS STUCK IN PLUNGER WHILE IMPLANTING THE LENS. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, THE ISSUE OCCURRED DURING IMPLANTATION AND THE SURGERY WAS COMPLETED WITH ALTERNATE LENS.
Patient problems: Insufficient Information
MAUDE report 24516257 ↗MalfunctionFeb 5, 2026Device Difficult to Setup or Prepare; Failure to Advance
ADDITIONAL INFORMATION RECEIVED AND STATED THAT PLUNGER BYPASSED THE IOL AND IT WAS NOT ABLE TO BE DISCHARGED FROM THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 24268515 ↗MalfunctionFeb 2, 2026Device Difficult to Setup or Prepare; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS FOUND TO BE DEFECTIVE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24235597 ↗MalfunctionDec 29, 2025Device Damaged by Another Device; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING CATARACT SURGERY WITH INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE IOL PLUNGER INCORRECTLY POSITIONED THE LENS WITHIN THE NARROW SECTION OF THE CARTRIDGE. THIS CAUSED PINCHING AND RESULTED IN DETACHMENT OF THE IOL HAPTIC ELEMENT AS IT EXITED THE DEVICE. THE PHYSICIAN REPLACED THE DAMAGED LENS WITH AN IDENTICAL IOL OF THE SAME DIOPTER POWER. THE PATIENT WAS NOT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908488 ↗MalfunctionDec 29, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A FACILITY REPRESENTATIVE REPORTED DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THAT HAPTIC OVER PLUNGER INCORRECTLY. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905718 ↗MalfunctionDec 26, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DID NOT INJECT THE LENS, INJECTOR MISSED IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23901041 ↗MalfunctionDec 12, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL) DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23789095 ↗MalfunctionDec 8, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS (IOL). ADDITIONAL INFORMATION HAS BEEN REQUESTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE POSTERIOR LOOP STUCK IN THE SHOOTER WITH NO PATIENT CONTACT. AS PER SURGEON IOL OR SHOOTER QUALITY DEFECT CAUSED OR CONTRIBUTED TO EVENT. THE PROCEDURE WAS NOT COMPLETED WITH A REPLACEMENT LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23735952 ↗MalfunctionNov 11, 2025Failure to Advance; Failure to Advance
A NON-HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PUSHER WENT UNDER LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23522654 ↗MalfunctionSep 16, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE LENS WAS DAMAGED BY HANDPIECE INJECTOR. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT, INJECTOR WAS DEFECTIVE AND THE LENS FOLDED ON ITSELF. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23061987 ↗MalfunctionSep 15, 2025Failure to Deliver; Failure to Deliver
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS DID NOT INSERT CORRECTLY WITH PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED BACKUP LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23051072 ↗MalfunctionSep 9, 2025Device Difficult to Setup or Prepare; Activation Problem; Device Difficult to Setup or Prepare; Activation Problem
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, THE INJECTOR ADVANCED UNUSUALLY SLOWLY, AND THE LENS HAPTIC APPEARED TO GET CAUGHT ON THE BLUE PLUNGER. AS A RESULT, THE LENS HAD TO BE CUT OUT, AND A NEW LENS WAS OPENED AND SUCCESSFULLY IMPLANTED INTO THE PATIENT ADDITIONAL INFORMATION INDICATED THAT THE LENS WAS IMPLANTED AND SUBSEQUENTLY REMOVED DURING THE INITIAL PROCEDURE. THERE WAS NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23005537 ↗InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION THE SURGEON NOTICED THE POSTERIOR CAPSULE TEAR. THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON SAME DAY WITHOUT ANY FURTHER ISSUES.
Patient problems: Capsular Bag Tear
MAUDE report 22567058 ↗MalfunctionJul 3, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL HAPTIC WAS DAMAGED OR JAMMED IN THE DELIVERY SYSTEM OR MISFIRED. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, LENS WAS STUCK AND WOULD NOT ADVANCE. THE SURGERY WAS COMPLETED ON THE SAME DAY AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22393853 ↗MalfunctionJun 20, 2025Failure to Deliver; Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS STUCK IN DEVICE. PATIENT CONTACT OCCURRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22299148 ↗MalfunctionJun 13, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS OBSERVED THAT THE LENS WOULD NOT ADVANCE.
Patient problems: Insufficient Information
MAUDE report 22203788 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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