Clareon™ CNA0T0 (REF CNA0T0.215)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 multifocal lens, which comes preloaded in its own injector, has 107 reports, no deaths and 5 injuries. Many reports describe the lens sticking in the injector or failing to leave the cartridge, and some describe a torn or twisted edge found during cataract surgery. A report describes tiny light-scattering spots inside the lens, though the patient was reported to have no symptoms. 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
- 107
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 107 adverse event reports that list this exact device (DI 00380652393744), received between Nov 8, 2021 and Sep 29, 2026 — classified as 5 injuries, 102 malfunctions.
The most frequently reported specific device problem is “Failure to Advance” (22 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
- Failure to Advance22
- Device Difficult to Setup or Prepare17
- Failure to Eject17
- Device Damaged by Another Device15
- Failure to Deliver13
- Material Twisted/Bent9
- Scratched Material6
- Failure to Unfold or Unwrap5
Patient problems
- Insufficient Information54
- No Clinical Signs, Symptoms or Conditions51
- Blurred Vision1
- Capsular Bag Tear1
- Intraocular Pressure Increased1
- Uveitis1
Recent adverse event reports
The 25 most recent of 107 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Advance; Device Damaged by Another Device
A nurse reported that during an intraocular lens (IOL) implant procedure, plunger went through the IOL and the IOL was damaged. The surgery was completed on the same day by using a replacement lens. There was no patient harm.Additional information was received and stated, there was no patient contact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931166 ↗MalfunctionSep 17, 2026Device Difficult to Setup or Prepare
A non-health care professional reported that during an intraocular lens (IOL) implantation procedure, leading haptic folded behind optic. The procedure was completed on the same day, and the tip of the pre-loaded device was not in contact with 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 50800245 ↗MalfunctionSep 16, 2026Device Difficult to Setup or Prepare
A non-healthcare professional reported that during intraocular lens (IOL) implantation, an issue with the trailing haptic was noticed. As a result, the lens was not implanted. Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50787844 ↗MalfunctionSep 15, 2026Material Twisted/Bent
A health care professional reported that during the intraocular lens (IOL) implant procedure, the trailing haptic slightly distorted not straight and not fully tucked onto optics. There was no patient contact and no patient harm.Additional information has been requested, yet no new information received.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50772570 ↗MalfunctionSep 2, 2026Device Difficult to Setup or Prepare
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564931 ↗MalfunctionAug 27, 2026Failure to Deliver
A non-healthcare professional reported that the lens was stuck in the injector.Additional information has been requested but no information is available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50475913 ↗MalfunctionJul 27, 2026Failure to Fold; Scratched Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50017318 ↗MalfunctionJun 1, 2026Material Twisted/Bent; Scratched Material
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE LENS FOUND TO BE TWISTED AND MARKS ON LENS. THE LENS WAS REMOVED AND REPLACED WITH A BACKUP LENS. THERE WAS NO IMPACT TO THE PATIENT. THE SURGERY WAS COMPLETED ON THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351012 ↗MalfunctionMay 11, 2026Material Deformation
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON HAD NOTICED SUB SURFACE NANO GLISTENING'S (SSNGS) AND THE SCHEDULED PROCEDURE COMPLETED THE SAME DAY. IN THE SURGEON¿S OPINION, IOL MATERIAL CAUSED OR CONTRIBUTED TO THE EVENT. PATIENT ISSUES WAS NOT YET RESOLVED BECAUSE VISIBLE SSNGS WILL LIKELY BE PERMANENT, THOUGH PATIENT ASYMPTOMATIC. IN SURGEON¿S PROGNOSIS CONDITION WAS EXCELLENT FROM A SYMPTOM STANDPOINT.
Patient problems: Insufficient Information
MAUDE report 25137411 ↗MalfunctionApr 24, 2026Failure to Prime; Material Twisted/Bent
A NURSE REPORTED THAT DURING CALIBRATION PROCEDURE, STATED THAT PLUNGER ADVANCED TO THE RIGHT, CAUSING BACK HAPTIC TO STRAIGHTEN. ACCORDING TO ADDITIONAL INFORMATION RECEIVED STATED THAT THE INITIAL PROCEDURE COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24979958 ↗MalfunctionApr 17, 2026Failure to Prime; Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING SURGERY, THEY NOTICED THAT THE LENS OVERRODE THE PLUNGER WITH NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT IT DID NOT GET DISPENSED PROPERLY. LOADER CRUSHED LENS AND THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24908696 ↗MalfunctionApr 9, 2026Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN THE IOL WAS BEING OPENED, THE LENS WAS TORN. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED STATING THAT THE ISSUE OCCURRED WHILE LOADING THE LENS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24832272 ↗MalfunctionApr 6, 2026Failure to Deliver
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IMPLANT DIDN'T DEPLOY DURING INJECTION. THE SURGERY WAS COMPLETED WITH ANOTHER IMPLANT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24791670 ↗MalfunctionMar 30, 2026Failure to Advance; Device Damaged by Another Device
A PHYSICIAN REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE PLUNGER INCORRECTLY POSITIONED THE LENS, WHICH LED TO ENTRAPMENT AND DEFORMATION OF THE IOL IN THE NARROW PART OF THE CARTRIDGE. THE LENS DID NOT EXIT THE CARTRIDGE. THE PROCEDURE COMPLETED IN THE SAME DAY WITH ANOTHER LENS. THERE WAS NO PATIENT INVOLVEMENT AND IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24712864 ↗MalfunctionMar 5, 2026Failure to Deliver
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS DID NOT ADVANCE. ADDITIONAL INFORMATION WAS RECEIVED THAT SURGEON MANAGED TO INSERT THE SAME LENS.
Patient problems: Insufficient Information
MAUDE report 24516243 ↗MalfunctionFeb 27, 2026Device Difficult to Setup or Prepare; Failure to Deliver; Failure to Advance
A NURSE REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR WAS FAULTY. PLUNGER OVERRODE LENS AND LENS GOT STUCK IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24472283 ↗MalfunctionFeb 20, 2026Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED THAT LENS BECAME STUCK IN THE INJECTOR AND COULD NOT BE IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24401040 ↗MalfunctionFeb 16, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE END OF THE IOL IMPLANTATION NOTICED THAT THE LENS WAS IN SUPERMAN POSITION (ANTERIOR HAPTIC WAS OVEREXTENDED AND NOT FOLDED) AND THE LOWER HAPTIC WAS POSITIONED DIAGONALLY IN THE SHOOTER, NEXT TO THE BLUE STAMP AT THE BOTTOM. SINCE IT WAS A MORE COMPLICATED AND SMALLER EYE, THE IMPLANTATION OF THE SUPERMAN LENS REQUIRES A SPECIAL ROTATION/PLACEMENT AND SINCE THE SAME DIOPTER LENS WAS NO LONGER AVAILABLE TWO OTHER LENSES WITH A +0.50 DIOPTERS DIFFERENCE WERE OPENED, AND IT WAS NOTICED THAT ALL LENSES WERE IN THIS EXTREME SUPERMAN POSITION AND ALSO THAT THE LOWER HAPTIC WAS NOT CENTERED (POSTERIOR HAPTIC) WAS LYING NEXT TO THE BLUE SHOOTER. AS THERE WERE NO MORE SUITABLE LENSES AVAILABLE, THE FIRST LENS WAS CHOSEN AND IMPLANTED. AS MENTIONED, IT HAD TO BE ROTATED, WHICH WAS POSSIBLE WITHOUT COMPLICATIONS BUT WAS TEDIOUS AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. HOWEVER, THE POTENTIAL RISK OF COMPLICATIONS DUE TO THE INTRAOCULAR ROTATION/TURNING REQUIRED (CAPSULAR RUPTURE, LENS DISLOCATION) WAS HIGHER THAN WITH A CORRECTLY PLACED LENS IN THE SHOOTER, AND THE SURGERY TIME WAS
Patient problems: Insufficient Information
MAUDE report 24344716 ↗MalfunctionFeb 16, 2026Device Damaged by Another Device
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS MANGLED IN CARTRIDGE, WITH NO PATIENT CONTACT. 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 24344714 ↗MalfunctionFeb 14, 2026Device Difficult to Setup or Prepare
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTICED THAT THE TRAILING HAPTIC/HALF OF THE LENS WAS STUCK IN THE INJECTOR. SURGEON MANAGED TO INJECT THE SAME LENS WITH A SECOND INSTRUMENT SUPPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24340727 ↗MalfunctionFeb 6, 2026Device Difficult to Setup or Prepare; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, AT THE END OF THE IOL IMPLANTATION NOTICED THAT THE LENS WAS IN SUPERMAN POSITION (ANTERIOR HAPTIC WAS OVEREXTENDED AND NOT FOLDED) AND THE LOWER HAPTIC WAS POSITIONED DIAGONALLY IN THE SHOOTER, NEXT TO THE BLUE STAMP AT THE BOTTOM. SINCE IT WAS A MORE COMPLICATED AND SMALLER EYE, THE IMPLANTATION OF THE SUPERMAN LENS REQUIRES A SPECIAL ROTATION/PLACEMENT AND SINCE THE SAME DIOPTER LENS WAS NO LONGER AVAILABLE TWO OTHER LENSES WITH A +0.50 DIOPTERS DIFFERENCE WERE OPENED, AND IT WAS NOTICED THAT ALL LENSES WERE IN THIS EXTREME SUPERMAN POSITION AND ALSO THAT THE LOWER HAPTIC WAS NOT CENTERED (POSTERIOR HAPTIC) WAS LYING NEXT TO THE BLUE SHOOTER. AS THERE WERE NO MORE SUITABLE LENSES AVAILABLE, THE FIRST LENS WAS CHOSEN AND IMPLANTED. AS MENTIONED, IT HAD TO BE ROTATED, WHICH WAS POSSIBLE WITHOUT COMPLICATIONS BUT WAS TEDIOUS AND THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. HOWEVER, THE POTENTIAL RISK OF COMPLICATIONS DUE TO THE INTRAOCULAR ROTATION/TURNING REQUIRED (CAPSULAR RUPTURE, LENS DISLOCATION) WAS HIGHER THAN WITH A CORRECTLY PLACED LENS IN THE SHOOTER, AND THE SURGERY TIME WAS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279154 ↗MalfunctionFeb 6, 2026Device Difficult to Setup or Prepare; Failure to Advance
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THE PLUNGER BYPASSED THE IOL AND IT WAS NOT ABLE TO BE DISCHARGED FROM THE CARTRIDGE.
Patient problems: Insufficient Information
MAUDE report 24278954 ↗MalfunctionJan 13, 2026Device Difficult to Setup or Prepare; Failure to Prime; Failure to Advance
A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL)IMPLANTATION SURGERY, THE HAPTIC WAS DEFORMED AND THERE WAS LENS LOADING DIFFICULTIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24052326 ↗MalfunctionJan 9, 2026Failure to Fold
A PHARMACIST REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT THE LENS WAS INCORRECTLY FOLDED INSIDE THE CARTRIDGE. THE PROCEDURE WAS COMPLETED WITH SAME MODEL AND DIOPTER COMPANY LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24019362 ↗MalfunctionJan 7, 2026Device Difficult to Setup or Prepare
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, A FAULTY INJECTOR, THE HAPTIC TO BE POSITIONED POSTERIORLY. THE ISSUE OCCURRED PRIOR TO INSERTION INTO THE EYE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988967 ↗
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 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
- 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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