Clareon™ CNA0T0 (REF CNA0T0.175)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 is preloaded for insertion into the eye. Reports mostly describe problems preparing, ejecting, or delivering the lens, sometimes with lens damage or blurred vision that led to replacement. There are 25 reports, no deaths, and 2 injuries. A recall began in May 2022 and is closed; it involved mislabeling from product mixing during overlapping manufacturing runs and improper production-line clearance.
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
- 27
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00380652393669), received between Apr 29, 2022 and Sep 23, 2026 — classified as 2 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (7 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
- Device Difficult to Setup or Prepare7
- Failure to Eject6
- Device Damaged by Another Device4
- Failure to Deliver3
- Adverse Event Without Identified Device or Use Problem2
- Material Deformation2
- Defective Device1
- Failure to Advance1
Patient problems
- Insufficient Information13
- No Clinical Signs, Symptoms or Conditions12
- Blurred Vision2
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Material Deformation
A physician reported that subsurface nanoglistenings (SSNGs) were observed after intraocular lens implantation surgery.Additional information was received stating that there had been no visual impact to patient at all and the lens remained in the eye.There are multiple medical reports associated with same event. This file is 3 of 29.
Patient problems: Insufficient Information
MAUDE report 50867618 ↗MalfunctionSep 22, 2026Device Difficult to Setup or Prepare
A facility Representative reported that during an intraocular lens (IOL) implantation procedure, leading haptic was stuck in the cartridge. There was no patient contact. The procedure 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 50855332 ↗InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION, THE PATIENT WAS NOT HAPPY WITH THE RESULTS. THE LENS WAS REMOVED AND REPLACED WITH AN ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANTATION WAS THAT THE PATIENT WAS NOT ABLE TO SEE CLEARLY. BASED ON ADDITIONAL INFORMATION RECEIVED, THE LENS EXCHANGE WAS DONE WITH A DIFFERENT COMPANY LENS. THE SURGERY INVOLVED RIGHT EYE.
Patient problems: Blurred Vision
MAUDE report 24999682 ↗MalfunctionApr 27, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE TAIL ON THE LENS MALFUNCTIONED WHEN THE SURGEON STARTED DEPLOYING THE LENS. THE SURGEON IMMEDIATELY STOPPED ADVANCING THE LENS. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER UNSPECIFIED LENS. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999131 ↗InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem
A NON¿HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT STRUGGLED TO READ SMALL PRINT. THE CLINICAL REASON WAS NOTED AS BLURRY VISUAL ACUITY. THE IOL WAS EXPLANTED DURING THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL REPORTS ASSOCIATED WITH THIS PATIENT. THIS IS FOR BILATERAL 1 OF 2.
Patient problems: Blurred Vision
MAUDE report 24983181 ↗MalfunctionApr 8, 2026Product Quality Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE THE SURGEON NOTICED DEFECT ON THE PERIPHERY OF THE LENS. THE IOL LEFT IMPLANTED IN THE EYE AS THE DEFECT WAS ON THE PERIPHERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24816632 ↗MalfunctionJan 9, 2026Inaccurate Delivery
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, STATED EXTERIORIZATION AT THE EDGE, LENS DID NOT FULLY ENTER THE EYE; IT REMAINED AT THE INCISION EDGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LENS. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Insufficient Information
MAUDE report 24021700 ↗MalfunctionDec 19, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE INJECTOR DID NOT WORK DURING PLACEMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23854483 ↗MalfunctionNov 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS MALFUNCTIONED BY NOT TRANSFERRING CORRECTLY BEFORE BEING IMPLANTED. THE MALFUNCTION WAS DETECTED BEFORE IMPLANTING INTO THE PATIENT AND ANOTHER LENS WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED, LENS HAD A LEADING HAPTIC. THE ISSUE WAS NOTICED DURING PRIMING AND THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23580018 ↗MalfunctionNov 14, 2025Failure to Prime; Device Damaged by Another Device; Failure to Prime; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, UPON ACTIVATION, THE PLUNGER BENT AND DAMAGED THE LENS WITH NO PATIENT CONTACT. THE PATIENT WAS NOT SUFFERED, AND THE PROCEDURE WAS COMPLETED ON SAME DAY WITH ANOTHER REPLACEMENT LENS. CURRENT PATIENT'S CONDITION WAS SATISFACTORY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23552081 ↗MalfunctionNov 6, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION, THE IMPLANT WAS IMPROPERLY BENT INSIDE THE INJECTOR. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23484312 ↗MalfunctionOct 23, 2025Device Difficult to Setup or Prepare; Material Twisted/Bent; Device Difficult to Setup or Prepare; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, BEFORE INTRAOCULAR LENS IMPLANTATION SURGERY, THE HOUSING WAS BENT AND HENCE THE LENS COULD NOT BE INSERTED.
Patient problems: Insufficient Information
MAUDE report 23369513 ↗MalfunctionSep 2, 2025Device Difficult to Setup or Prepare; Failure to Deliver; Device Difficult to Setup or Prepare; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IOL IMPLANT PROCEDURE, WHEN TRYING TO ADVANCE AND DEPLOY THE LENS, THE HAPTIC CAME OUT FOLDED AND DID NOT ALLOW THE REST OF THE LENS TO DEPLOY FREELY. IT DID NOT FULLY DEPLOY, SO IT WAS NOT COMPLETELY IMPLANTED AND WAS FULLY REMOVED. THE LENS STAYED IN THE DELIVERY SYSTEM AND WAS PULLED OUT WITH INSTRUMENT ASSISTANCE ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED THE SAME DAY WITHOUT ANY HARM TO THE PATIENT. IN THE SURGEON'S OPINION, THE LENS MAY HAVE NOT BEEN LOADED CORRECTLY DURING MANUFACTURING BUT WAS UNSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22944411 ↗MalfunctionJul 16, 2025Failure to Fold; Failure to Deliver; Failure to Fold; Failure to Deliver
A NON HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, NOTICED THAT THE LENS DID NOT ADVANCE IN THE INJECTOR AND IT WAS FOLDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22517855 ↗MalfunctionJul 10, 2025Material Deformation; Material Deformation
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SURGEON HAS USED THE PRELOAD DEVICE AND NOTICED A CLEAR BAND LIKE TIP OF THE CARTRIDGE AND IT WAS SOMEHOW SHAVED OFF AND LEFT ON THE TIP OF THE CARTRIDGE. AS SURGEON WAS USING PRELOAD DEVICE TO IMPLANT IOL, BAND GOT CAUGHT ON THE LEADING HAPTIC AND IT WAS IMPLANTED IN THE EYE. THE SURGEON DESCRIBED THE BAND WAS BEING MUCH MORE MALLEABLE THAN HE WOULD EXPECT AND IT WAS PART OF THE CARTRIDGE. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH THE 2 OF 3 FILES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22469885 ↗MalfunctionMar 15, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE THE HAPTIC PRESENTED IN FRONT. HE SPECIFIED THAT THE EYE WAS SMALL AND COMPLEX, SO IMPLANTATION WAS DELICATE. FACED WITH THE RISK OF CAPSULAR RUPTURE, SURGEON DECIDED NOT TO USE THE IMPLANT IN THE END. THE SURGERY WAS COMPLETED WITH THE SAME MODEL AND SAME DIOPTER LENS. NO PATIENT IMPACT WAS REPORTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 2. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21613051 ↗MalfunctionMar 6, 2025Failure to Deliver; Failure to Deliver
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS IMPLANTATION PROCEDURE THE LENS STUCK AND UNABLE TO ADVANCE. THERE WAS A PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21533933 ↗MalfunctionFeb 19, 2025Failure to Advance; Failure to Advance
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY, THE PLUNGER WENT OVER OR UNDER THE DEVICE, NOT ADVANCING THE LENS FAR ENOUGH TO EJECT. ADDITIONAL INFORMATION HAS BEEN RECEIVED, STATING THAT, THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, ALL THE FOUR LENSES WERE USED ON THE SAME PATIENT.
Patient problems: Insufficient Information
MAUDE report 21411161 ↗MalfunctionJan 15, 2025Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, ALL THE FOUR LENSES WERE USED ON THE SAME PATIENT. THIS IS THE FIRST OF FOUR-PRODUCT REPORT FOR THIS PATIENT FROM REPORTING FACILITY RELATED TO THE SAME EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21160191 ↗MalfunctionJan 15, 2025Failure to Eject; Failure to Eject
ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT, ALL THE LENSES WERE USED ON THE SAME PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21160190 ↗MalfunctionDec 11, 2024Failure to Eject; Failure to Eject
A NON HEALTHCARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS WOULD NOT ADVANCE. ALSO STATED THAT THE LENS WAS STUCK BEHIND THE PLUNGER. WOULD NOT ADVANCE. BLUE PART CAME FORWARD BUT LEFT THE LENS BEHIND. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20901263 ↗MalfunctionNov 28, 2024Failure to Eject; Failure to Eject
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS FAILED TO DEPLOY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20805830 ↗MalfunctionNov 27, 2024Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED WITH THE DESCRIPTION, SCRATCHED IMPLANT WITH INJECTOR IN THE MIDDLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20794906 ↗MalfunctionJul 23, 2024Failure to Eject; Failure to Eject
A PHARMACIST REPORTED THAT DURING SURGERY, THEY NOTICED A PLACEMENT FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 19805769 ↗MalfunctionJul 11, 2024Optical Decentration; Failure to Eject; Optical Decentration; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IT WAS NOTED THAT A HAPTIC OF A LENS WAS STUCK INSIDE THE SHOOTER (INSERTION CARTRIDGE). IN THE END, THE HAPTIC CAME ALONG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED TRAILING HAPTIC OF A LENS WAS STUCK INSIDE THE SHOOTER. THE PATIENT DID NOT HAVE ANY NEGATIVE CONSEQUENCES, BUT THE LENS DID NOT HAVE AN OPTIMAL CENTRALIST. THIS REPORT IS ASSOCIATED WITH MULTIPLE COMPLAINTS. THIS FILE IS 2 OF 2.
Patient problems: Insufficient Information
MAUDE report 19725347 ↗
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 · 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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