Clareon™ CNWTT3 (UDI 00380652468626)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
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380652468626), received between Mar 14, 2023 and Feb 13, 2026 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Defective Device1
- Malposition of Device1
- Scratched Material1
Patient problems
- Blurred Vision3
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Visual Impairment1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT PATIENT CONDITION WAS UNCHANGED. PATIENT¿S SECOND EYE (LEFT EYE) WAS OPERATED, WHICH HAD OKAY RESULT, THIS WAY THE PROBLEM OF THE FIRST EYE, RIGHT EYE WAS NOT SO URGENT. NOW THEIR PLAN WAS TO WAIT FOR THE IOL TO FULLY STABILIZE IN THE BAG AND MAKE SURE THE SUBJECTIVE REFRACTION WAS STABLE AND PERFORM LASER VISION CORRECTION LATER.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 24334546 ↗InjuryOct 11, 2024Break; Malposition of Device; Break; Malposition of Device
A HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE SURGEON HAD TO ROTATE THE LENS AFTER IMPLANTATION. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT PATIENT EXPERIENCED LOSS OF VISUAL ACUITY DUE TO IOL ROTATION. THE EVENT MAY BE OCCURRED DUE TO THE IMPROPER USE OF THE INJECTOR. THE VIDEOS OF THE CASE CLEARLY SHOW THAT THE LENS WAS IMPLANTED NORMALLY AND WAS LEFT INTACT THE FRACTURE OF HAPTICS OCCURRED A FEW DAYS LATER. THE LENS WAS ROTATED AND THE PATIENT WAS FINE. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS FILE. THIS REPORT IS ASSOCIATED WITH 1 OF 3.
Patient problems: Blurred Vision
MAUDE report 20426167 ↗MalfunctionFeb 16, 2024Scratched Material; Scratched Material
A FACILITY REPRESENTATIVE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS SCRATCHED. THE LENS WAS REMOVED DURING THE INITIAL PROCEDURE. ADDITIONAL INFORMATION HAS BEEN RECEIVED THAT THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18721700 ↗InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED ABOUT A INTRAOCULAR LENS (IOL) EXPLANT IN A SECONDARY PROCEDURE DUE TO BLURRY VISION. THE IOL WAS REPLACED WITH ANOTHER IOL.
Patient problems: Blurred Vision
MAUDE report 16867117 ↗MalfunctionMar 14, 2023Defective Device; Defective Device
A NON-HEALTHCARE PROFESSIONAL REPORTED WITH THE DESCRIPTION OF DEFECTIVE INTRAOCULAR LENS. ADDITIONAL INFORMATION WAS REQUESTED
Patient problems: Insufficient Information
MAUDE report 16538753 ↗
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.