Clareon™ CNWTT3 (UDI 00380652468497)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable Diffractive Aspheric Toric Posterior Chamber Intraocular Lens · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652468497), received between Nov 28, 2022 and Aug 11, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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 Problem2
- Defective Device1
- Failure to Deliver1
- Patient Device Interaction Problem1
Patient problems
- Blurred Vision2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION HAS BEEN RECEIVED AND STATED THE PATIENT VISION HAS NOT IMPROVED. HE CAN READ OK, BUT COMPUTER AND DRIVING WERE NOT CLEAR. THE EYEGLASSES HELP BUT SURGEON ENCOURAGED HIM NOT TO WEAR THEM SO HIS VISION COULD IMPROVE. HE SAW HIS SURGEON AND REALLY DIDN'T GET ANY ADDITIONAL INFORMATION EXCEPT THAT THE SURGEON SAID HE NO LONGER HAS THE LASER THAT WOULD HELP TO IMPROVE HIS VISION. HE WILL ALSO HAVE A 2ND OPINION AT A FACILITY WHO IS ABLE TO USE A VISION CORRECTING LASER.
Patient problems: Blurred Vision
MAUDE report 22770869 ↗MalfunctionMay 26, 2025Failure to Deliver; Failure to Deliver
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT INTRAOCULAR LENS (IOL) FOUND TO BE STUCK IN CARTRIDGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 22084936 ↗InjuryMay 22, 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 FRUSTRATED WITH NEAR AND DISTANT VISION. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 02 MONTHS 07 DAYS FOLLOWING THE INITIAL PROCEDURE. CLINICAL REASON FOR EXPLANT WAS MENTIONED AS NO IMPROVEMENT NEAR JS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 19372863 ↗InjuryNov 28, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem
A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED MACULAR DEGENERATION. ALSO STATED THAT, THE IOL NOT FUNCTIONING PROPERLY. THEY HAVE PLANNED FOR THE EXPLANT OF THE IOL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 15867996 ↗
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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