Clareon™ CNWTT4 (UDI 00380652469005)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
- 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 00380652469005), received between Dec 14, 2022 and Aug 29, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Scratched Material” (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 Problem3
- Scratched Material1
Patient problems
- Visual Disturbances2
- Blurred Vision1
- Corneal Edema1
- Halo1
- 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 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED SIGNIFICANT CORNEAL EDEMA. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Corneal Edema
MAUDE report 22920671 ↗InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT, PATIENT REASON AND CLINICAL REASON FOR THE EXPLANT WAS MENTIONED AS GLARE/HALOS. THE LENS WAS EXCHANGED FOR ANOTHER LENS MODEL 07 MONTHS 10 DAYS FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS PATIENT. THIS REPORT IS ASSOCIATED WITH THE RIGHT EYE.
Patient problems: Halo; Visual Disturbances
MAUDE report 20377529 ↗MalfunctionAug 29, 2024Scratched Material; Scratched Material
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WHEN LOADING THE LENS, THERE WAS STIFFNESS BETWEEN THE INJECTOR AND THE LENS AND THE PLUNGER WAS MOVED BACK AND FORTH A LOT. WHEN THE LENS WAS IMPLANTED, A LOT OF THIN AND THICK SCRATCHES WERE OBSERVED AT THE LENS OPTIC CENTER. THE LENS WAS REMOVED QUICKLY AND IMPLANTED WITH AN ANOTHER COMPANY LENS.
Patient problems: Insufficient Information
MAUDE report 20099766 ↗InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED DECREASED BLURRY VISUAL ACUITY, SEVERE POSITIVE DYSPHOTOPSIA. THE IOL WAS EXCHANGED IN A SECONDARY PROCEDURE FOLLOWING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.
Patient problems: Blurred Vision; Visual Disturbances
MAUDE report 15976554 ↗
Other LENS, INTRAOCULAR, TORIC OPTICS devices
- TECNIS IOL ZCT150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS1 recall7 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS43 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS36 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS32 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS30 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS29 reports
- Clareon CNWTT0Alcon Laboratories, Inc. · LENS, INTRAOCULAR, TORIC OPTICS21 reports
- TECNIS IOL DIU150Johnson & Johnson Surgical Vision, Inc. · LENS, INTRAOCULAR, TORIC OPTICS19 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.