Clareon CNWTT0 (UDI 00380652408189)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon Clareon CNWTT0 is a foldable intraocular lens implanted in cataract surgery. Across 31 reports, the problems described are mostly lens parts breaking or cracking during implantation, and optics that arrive scratched or cannot be folded, so a backup lens is often used instead. Patients in some reports experienced blurred vision, halos around lights, or other visual disturbance, and 14 injuries were reported with no deaths. 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
- 32
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00380652408189), received between Nov 14, 2022 and Sep 28, 2026 — classified as 14 injuries, 18 malfunctions.
The most frequently reported specific device problem is “Break” (7 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
- Adverse Event Without Identified Device or Use Problem13
- Break7
- Scratched Material5
- Device Damaged by Another Device2
- Failure to Deliver2
- Material Twisted/Bent2
- Product Quality Problem2
- Data Problem1
Patient problems
- Insufficient Information9
- No Clinical Signs, Symptoms or Conditions9
- Visual Disturbances7
- Blurred Vision5
- Halo5
- Visual Impairment4
- Discomfort1
- Dry Eye(s)1
Recent adverse event reports
The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
A non health care professional reported that the haptic was broken when it was being loaded into the cartridge.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 50915644 ↗MalfunctionAug 14, 2026Break
A non health care professional reported that during intraocular lens (IOL) implantation surgery, observed that haptic was broken. The lens was not able to implant and the surgery was completed on the same day with replacement lens. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50260005 ↗MalfunctionJun 3, 2026Failure to Fold; Device Damaged by Another Device
A PHARMACIST REPORTED WITH A DESCRIPTION THAT, THE IMPLANT WAS IMPOSSIBLE TO BEND. HENCE IT WAS SCRATCHED. A BACK UP LENS WAS USED TO COMPLETE THE SURGERY.
Patient problems: Insufficient Information
MAUDE report 25376022 ↗InjuryMay 21, 2026Product Quality Problem
A NURSE REPORTED THAT THE PATIENT EXPERIENCED POOR VISION FOLLOWING INTRAOCULAR LENS (IOL) IMPLANTATION. IT WAS REPORTED THAT THE IMPLANTED LENS WAS DEFECTIVE. AN EXPLANT PROCEDURE HAS BEEN PLANNED, WITH IMPLANTATION OF AN ANTERIOR CHAMBER INTRAOCULAR LENS (ATIOL). ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE LENS WAS REMOVED AND REPLACED WITH AN ADVANCED TECHNOLOGY INTRAOCULAR LENS (ATIOL) IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS REPORTED AS REFRACTIVE MISS, SUSPECTED DEFECT OF IOL AND POOR BEST CORRECTED VISUAL ACUITY.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 25242678 ↗MalfunctionMay 20, 2026Break; Material Twisted/Bent
A HEALTH CARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS RUPTURED. IT WAS ALSO STATED THAT IT WAS BROKEN OUT OF INJECTOR INTO BAG. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Insufficient Information
MAUDE report 25229008 ↗MalfunctionMar 6, 2026Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE HAPTIC HAD BROKEN, AND THE SURGEON HAD REPLACED THE LENS DURING THE SAME PROCEDURE. NO PATIENT HARM HAD BEEN REPORTED.
Patient problems: Insufficient Information
MAUDE report 24530571 ↗MalfunctionFeb 3, 2026Device Damaged Prior to Use; Scratched Material
A NURSE REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE OPTICS WERE SCRATCHED AND A BACK UP LENS WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED AND STATED THAT THERE WAS NO PATIENT CONTACT AND NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24245741 ↗MalfunctionJan 27, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, A SCRATCH WAS OBSERVED ON THE LENS. IT COULD NOT BE USED BY THE PATIENT. ADDITIONAL INFORMATION WAS REQUESTED AND NO NEW ADDITIONAL INFORMATION WAS RECEIVED.
Patient problems: Insufficient Information
MAUDE report 24188334 ↗MalfunctionJan 5, 2026Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A CRACK IN THE IOL AFTER IMPLANTATION. THE LENS WAS REMOVED AND EXCHANGED WITH UNSPECIFIED REPLACEMENT LENS DURING INITIAL PROCEDURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23957913 ↗MalfunctionDec 29, 2025Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT BEFORE AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THERE WAS A SCRATCH ON LENS. THE SURGERY WAS COMPLETED BY USING BACKUP LENS ON THE SAME DAY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23905712 ↗MalfunctionDec 26, 2025Material Twisted/Bent; Material Twisted/Bent
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, HAPTIC WAS BAD ON LENS. ADDITIONAL INFORMATION WAS RECEIVED IN SURGEON'S OPINION PRODUCT WAS CONTRIBUTED TO THE EVENT AND THERE WAS NO PATIENT CONTACT. THE PROCEDURE WAS COMPLETED ON SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23897293 ↗MalfunctionDec 17, 2025Break; Failure to Deliver; Material Split, Cut or Torn; Break; Failure to Deliver; Material Split, Cut or Torn
A HEALTHCARE PROFESSIONAL; REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) THE LENS HAPTIC STUCK IN CARTRIDGE AND BROKEN. THE SURGERY WAS COMPLETED ON THE SAME DAY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 23828897 ↗MalfunctionAug 21, 2025Failure to Deliver; Failure to Deliver
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS STUCK IN INJECTOR AND WOULD NOT ADVANCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information
MAUDE report 22860467 ↗MalfunctionJul 22, 2025Break; Break
THE HEALTH CARE PROFESSIONAL STATED THAT DURING LENS IMPLANTATION NOTED TRAILING HAPTIC WAS BROKEN AND STUCK ON CARTRIDGE WALL. THE LENS WAS REMOVED AND BACKUP LENS WAS USED TO COMPLETE THE SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22563468 ↗MalfunctionJun 18, 2025Scratched Material; Scratched Material
A PHYSICIAN REPORTED THAT, DURING INTRAOCULAR LENS IMPLANTATION SURGERY SCRATCHES WAS OBSERVED IN THE CENTRAL PART OF THE INTRAOCULAR LENS (IOL). SO, THE LENS WAS CUT, EXPLANTED AND REPLACED WITH A ANOTHER IOL WITH SAME DIOPTER DURING THE SAME PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT STATES THAT THE LENS WAS REMOVED FROM THE EYE WITHOUT CAUSING ANY HARM TO THE PATIENT. ANOTHER UNSPECIFIED LENS WITH THE SAME DIOPTER BUT A DIFFERENT MODEL WAS IMPLANTED IN ITS PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22279773 ↗MalfunctionJun 6, 2025Break; Break
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING CATARACT SURGERY, THE LENS WAS FRAGILE, AND ONE HAPTIC DETACHED. THE LENS HAD TO BE REMOVED AND REPLACED WITH ANOTHER ONE. THE SURGERY TOOK LONGER THAN EXPECTED, CAUSING DISCOMFORT FOR THE PATIENT. THERE WAS NO PERSONAL INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22156010 ↗InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT HAD SMART LENSES INSERTED IN BOTH EYES. ALTHOUGH PATIENT HAD GONE TO THE DOCTOR MANY TIMES AND CHANGED THE MEDICATIONS, HAD DIFFICULTY OPENING AND CLOSING EYES DUE TO THE BURNING, STINGING IN EYES AND EXCESSIVE BURNS AT THE BOTTOM OF EYELASHES. PATIENT WANTED TO IMPROVE QUALITY OF LIFE AS UNEASINESS INCREASED WITH THIS SURGERY. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. (1 OF 2) ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Eye Irritation; Unspecified Eye / Vision Problem
MAUDE report 22105781 ↗InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT CANNOT SEE TO DRIVE AT NIGHT BECAUSE THE HEADLIGHTS ALL LOOK LIKE FIREWORKS, HER CHRISTMAS TREE LOOKED LIKE FIREWORKS. ALL LIGHTS HAVE A TERRIBLE GLARE OR HALO. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THE PATIENT EXPERIENCED DECREASED VISION FROM GLARE AND HALOS, MORE SIGNIFICANTLY AT NIGHT WHILE DRIVING DUE TO WHICH SHE WAS UNABLE TO DRIVE. ADDITIONALLY, AN ALPHA-ADRENERGIC AGONIST DRUG HAS BEEN PRESCRIBED TO THE PATIENT TO CAUSE MIOSIS OF THE PUPIL. THERE WAS NO PATIENT HARM. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 21444989 ↗MalfunctionJan 9, 2025Device Damaged by Another Device; Device Damaged by Another Device
A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, IOL WAS DAMAGED IN THE CARTRIDGE DURING IMPLANTATION. ADDITIONAL INFORMATION WAS RECEIVED, THERE WAS PATIENT CONTACT. THE SURGERY WAS COMPLETED ON THE SAME DAY. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21112648 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Data Problem; Adverse Event Without Identified Device or Use Problem; Data Problem
A PHYSICIAN REPORTED THAT, THE PATIENT EXPERIENCED LESS VISION AND REFRACTIVE OUTCOME OF PATIENT WAS REPORTED AS 1.25 DIOPTERS HYPERMETROPIC. SO, INTRAOCULAR LENS (IOL) WAS EXPLANTED IN THE SECONDARY IMPLANT PROCEDURE. ADDITIONAL INFORMATION RECEIVED AND IT STATES THAT THE CORNEAL TOPOGRAPHY, BOTH PRE- AND POST-OPERATION, DO NOT SHOW ANY STRANGE IMAGES THAT COULD EXPLAINED THAT THE VISION OR OUTCOME CAN CHANGE. THE DOCTOR HAS PERFORMED AN IOL EXCHANGE OD (RIGHT EYE) AND NOW HAS A GOOD OUTCOME. BASED ON THE OD OUTCOME. DOCTOR HAS ADJUSTED THE IOL STRENGTH OS (LEFT EYE), THIS HAS NOW ALSO COME OUT WELL.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 21065973 ↗InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTHCARE PROFESSIONAL REPORTED THAT, AFTER INTRAOCULAR LENS IMPLANTATION SURGERY, THE PATIENT EXPERIENCED GLARE AT NIGHT. HENCE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LIGHT ADJUSTABLE LENS IN A SECONDARY PROCEDURE. THE CLINICAL REASON FOR EXPLANT WAS UNABLE TO ADAPT TO LENS. ADDITIONAL INFORMATION HAS BEEN RECEIVED STATING THAT THERE WAS NO PATIENT HARM.
Patient problems: Halo; Visual Disturbances
MAUDE report 21065489 ↗InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED WITH INTOLERANCE TO MULTIFOCALITY WITH HALOS AND THE SURGEON HAD TO EXPLANT THE IOL FROM THE LEFT EYE AND REPLACED IT WITH A MONO-FOCAL LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE LEFT EYE.
Patient problems: Halo
MAUDE report 20843023 ↗InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT INTOLERANCE TO MULTIFOCALITY (LUMINOUS HALOS). THE LENS WAS EXPLANTED AND REPLACED WITH MONOFOCAL LENS IN A SECONDARY PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Halo
MAUDE report 20735298 ↗MalfunctionSep 27, 2024Product Quality Problem; Product Quality Problem
A FACILITY REPRESENTATIVE REPORTED WITH A DESCRIPTION OF DEFECTIVE LENS. ADDITIONAL INFORMATION WAS REQUESTED. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS COMPLAINT. THIS REPORT IS 1 OF 4.
Patient problems: Insufficient Information
MAUDE report 20323034 ↗InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED POSTOPERATIVE DEGREE ERROR OCCURRED RELATIVE TO TARGET DEGREE AND AT 2 MONTHS AFTER SURGERY, SPHERICAL OF EQUIVALENT (SE) WAS -1.0D AND FAR VISUAL ACUITY WAS 0.2 (1.2). THE IOL WAS EXCHANGED FOR ANOTHER LENS MODEL FOLLOWING THE INITIAL IMPLANT PROCEDURE. APPROXIMATELY AFTER 3 MONTHS FROM INITIAL PROCEDURE, THE PATIENT'S FAR VISUAL ACUITY HAD IMPROVED TO 1.0 (1.2). THE SURGEON SUSPECTED THAT THE POWER OF THE IOL THAT WAS REMOVED MAY NOT HAVE BEEN THE INDICATED 22.5D. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Visual Impairment
MAUDE report 20134140 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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