Clareon CNWTT0 (UDI 00380652407854)Recalls & reported problems
Alcon Laboratories, Inc. · STERILE UV and Blue Light Filtering Hydrophobic Acrylic Foldable · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652407854), received between Jan 18, 2023 and Oct 20, 2023 — classified as 2 injuries.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Break1
Patient problems
- Blurred Vision2
- Visual Impairment1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2023Break; Break
A PHYSICIAN REPORTED THAT DURING INTRAOCULAR LENS (IOL) IMPLANTATION, A PARTIAL TEAR AT THE BASE OF THE HAPTIC WAS NOTICED. BUT THE SURGERY WAS PERFORMED AND COMPLETED WITHOUT PRODUCT REPLACEMENT. THERE WERE NO POSTOPERATIVE PROBLEMS, BUT LATER DUE TO SLIGHT CHANGE IN MYOPIA AND REDUCED VISUAL ACUITY, THE IOL WAS REPLACED WITH A COMPANY LENS IN A SECONDARY PROCEDURE. THE PHYSICIAN SAID THAT PATIENT FELT SOME DISCOMFORT AT THE TIME OF IMPLANTATION DURING FIRST OPERATION, AND ALSO FELT DISCOMFORT WHEN THE REPLACEMENT LENS WAS IMPLANTED LATER. THEREFORE, THE REPLACEMENT LENS WAS ALSO REMOVED IMMEDIATELY AND NEW LENS WAS IMPLANTED. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT'S SYMPTOMS HAVE BEEN RECOVERING.
Patient problems: Blurred Vision; Visual Impairment
MAUDE report 17974448 ↗InjuryJan 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A NON-HEALTHCARE PROFESSIONAL REPORTED THAT FOLLOWING A CATARACT EXTRACTION WITH INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION AND THE CLINICAL REASON WAS PATIENT NEEDS DIFFERENT POWER. THE IOL WAS EXPLANTED AND EXCHANGED IN A SECONDARY PROCEDURE FOR ATIOL (ADVANCED TECHNOLOGY INTRA OCULAR LENS) LENS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision
MAUDE report 16193928 ↗
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page