Clareon™ CNA0T0 (REF CNA0T0.275)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMeAutomated Pre-loaded Delivery System · Class 3 · Implant
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00380652396486), received between Sep 15, 2021 and Sep 24, 2026 — classified as 2 injuries, 19 malfunctions.
The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 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 Prepare3
- Failure to Advance2
- Failure to Eject2
- Inaccurate Delivery2
- Material Discolored2
- Unintended Ejection2
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- Insufficient Information8
- Blurred Vision1
- Capsular Bag Tear1
- Corneal Edema1
- Visual Impairment1
Recent adverse event reports
The 21 most recent of 21 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 stating that there was no visual impact and the lens remain implanted in the eye.There are multiple medical reports associated with same event. this file is 10 of 29.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884526 ↗MalfunctionSep 15, 2026Inaccurate Delivery
A non-healthcare professional reported that, during the intraocular lens (IOL) implantation procedure, the lens would not advance into the eye and became stuck in the incision.Additional information has been requested but is not available at the time of this report.
Patient problems: Insufficient Information
MAUDE report 50771212 ↗MalfunctionJul 27, 2026Failure to Advance
Patient problems: Insufficient Information
MAUDE report 50017997 ↗MalfunctionApr 20, 2026Failure to Fold
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, STATED MALFUNCTIONING LOAD. THE LENS WAS REMOVED AND A NEW LENS WAS IMPLANTED DURING THE SAME PROCEDURE. THE PATIENT CURRENT STATUS MENTIONED AS FULLY RECOVERED (ALSO MENTIONED AS UNKNOWN). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 24927288 ↗MalfunctionMar 2, 2026Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT THE DEVICE WAS FAULTY AND COULD NOT BE USED. THERE WAS NO PATIENT HARM. 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 24484380 ↗MalfunctionDec 30, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE HAPTIC FOUND TO BE SCREWED UP (LOADING ISSUE). THE LENS WAS NOT IMPLANTED IN THE EYE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23922444 ↗MalfunctionDec 2, 2025Break; Break
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE THE LENS WAS STUCK IN DELIVERY SYSTEM AND HAPTIC WAS BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY WITH UNSPECIFIED LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THAT THERE WAS PATIENT CONTACT AND NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23693634 ↗MalfunctionOct 31, 2025Failure to Advance; Failure to Advance
A HEALTHCARE PROFESSIONAL REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION, THE PLUNGER DID NOT ENGAGE THE LENS AND PASSED OVER IT. THE SURGERY WAS COMPLETED ON THE SAME DAY USING ANOTHER LENS. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439772 ↗MalfunctionJul 21, 2025Inaccurate Delivery; Inaccurate Delivery
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF FAULTY INTRAOCULAR LENS (IOL) DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, RECEIVED AND STATED THE LENS CAME OUT OF THE INTRODUCER WHILE THE INTRODUCER WAS BEING INSERTED IN TO THE EYE. THE IOL WAS EXPLANTED DURING INITIAL PROCEDURE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22554022 ↗MalfunctionMay 2, 2025Material Twisted/Bent; Material Twisted/Bent
A NURSE DURING SURGERY REPORTED THAT TRAILING HAPTIC WAS STRAIGHT AND THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED WITH A ANOTHER UNSPECIFIED LENS ON SAME DAY WITHOUT ANY HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21948683 ↗MalfunctionApr 18, 2025Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS PLACEMENT WAS FAILED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT PLACEMENT FAILURES WAS RELATED TO A BLOCKAGE IN INCISION.
Patient problems: Insufficient Information
MAUDE report 21864047 ↗MalfunctionOct 28, 2024Material Opacification; Material Opacification
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IN POSTOPERATIVE FOLLOW-UP VISIT SURGEON OBSERVED OPACIFICATION OF THE IOL OF THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 20552451 ↗MalfunctionFeb 23, 2024Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF INTRAOCULAR LENS (IOL) HAS REMAINED STUCK IN THE INJECTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18765968 ↗MalfunctionJan 3, 2024Material Discolored; Material Discolored
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED INTO PATIENT'S EYE AND NOTICED THAT PATIENT HAD THE SAME WEIRD SHEEN. PHYSICIAN JUST LEFT IT AND PROCEEDED WITH THE GONIOTOMY. PATIENT HAD CORNEAL EDEMA ,SO COULDN¿T SEE THE IOL THAT WELL BUT STILL COULD SEE THE SHEEN. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 2 OF 2.
Patient problems: Corneal Edema
MAUDE report 18433965 ↗MalfunctionDec 29, 2023Material Discolored; Particulates; Material Discolored; Particulates
A PHYSICIAN REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS IMPLANTED INTO PATIENT'S EYE AND NOTICED POLYCHROMATIC FILM APPEARING TO BE ON THE ANTERIOR SIDE OF THE IOL.SUBSEQUENTLY, IT WAS REMOVED DURING INITIAL PROCEDURE AND COMPLETED WITH NEW IOL. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 2.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18418102 ↗MalfunctionOct 5, 2023Difficult to Advance; Difficult to Advance
A MATERIALS MANAGER REPORTED THAT DURING INTRAOCULAR LENS (IOL)IMPLANTATION, THERE WAS DIFFICULTY INJECTING THE LENS INTO THE EYE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED, BUT NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17877128 ↗InjuryMay 26, 2023Defective Device; Defective Device
A PHYSICIAN REPORTED THAT DURING A CATARACT EXTRACTION WITH AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LEADING HAPTIC CAME OUT STRAIGHT AND BROKE CAPSULAR BAG. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Capsular Bag Tear
MAUDE report 17008696 ↗MalfunctionDec 13, 2022Unintended Ejection; Unintended Ejection
A NON HEALTHCARE PROFESSIONAL REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) WHEN PLACING THE LENS IN THE PATIENT'S EYE, THE INJECTOR CAME OUT OF THE PEN AND THE LENS WAS OUT OF THE PATIENT'S EYE. THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15969622 ↗InjuryOct 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NURSE REPORTED THAT FOLLOWING IMPLANTATION OF INTRAOCULAR LENS (IOL), THE PATIENT HAS BLURRY VISION. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE APPROXIMATELY WITHIN A MONTH AFTER INITIAL PROCEDURE FOR CLINICAL REASON OF SPHERICAL CORRECTION. THE LENS WAS REPLACED WITH ANOTHER MONOFOCAL IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 15563984 ↗MalfunctionOct 13, 2021Unintended Ejection; Unintended Ejection
A PHARMACIST REPORTED THAT DURING IMPLANTATION OF AN INTRAOCULAR LENS (IOL) THE IMPLANT WAS RELEASED CAME OUT FROM INJECTOR AT THE FIRST PRESS ON THE BLUE PUSH BUTTON. THE IMPLANT WAS PLACED QUICKLY BY THE SURGEON. MORE DELICATE GESTURE FROM SURGEON AS THERE WAS LITTLE TIME TO APPRECIATE THE POSITIONING OF THE IMPLANT. ADDITIONAL INFORMATION WAS RECEIVED STATING IMPLANT HAS BEEN CORRECTLY PLACED, DESPITE THE INCIDENT NO EXPLANTATION NEEDED. THE IMPLANT STILL IN PATIENT EYE, NO CLINICAL CONSEQUENCES. NO LOSS OF VISUAL ACUITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12625004 ↗MalfunctionSep 15, 2021Failure to Eject; Failure to Eject
A HEALTH CARE PROFESSIONAL REPORTED DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION THE IMPLANT WAS DEFECTIVE AND WAS IMPOSSIBLE TO INJECT. THERE WAS NO PATIENT HARM REPORTED. ADDITIONAL INFORMATION RECEIVED STATING THAT DURING THE INSERTION OF THE IOL INTO THE PATIENT'S EYE THE IOL WAS BLOCKED IN THE INJECTOR. THE SURGERY WAS COMPLETED DURING THE SAME INTERVENTION WITH A BACK UP LENS, NO RESCHEDULING WAS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12477165 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.