Clareon™ CNWTT4 (UDI 00380652468923)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
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 00380652468923), received between Oct 27, 2025 and Dec 5, 2025 — classified as 2 injuries.
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 Problem2
Patient problems
- Visual Impairment2
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryDec 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, PATIENT EXPERIENCED REFRACTIVE SURPRISE WITH ASTIGMATISM AND UNDER CORRECTION DESPITE OF PERFECT POSITIONING. AFTER FURTHER DISCUSSION, IT TURNS OUT THE DOCTOR SIMPLY MADE AN INCORRECT CALCULATION OR ESTIMATION. SO, THERE WAS NOTHING WRONG WITH THE COMPANY LENS. THE LENS STILL REMAINS IN THE PATIENT EYE AND WAS PLANNED TO BE EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, AFTER 6 WEEKS OF INITIAL PROCEDURE THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER LENS ON (B)(6) 2025. THE SYMPTOMS WERE RESOLVED AND THERE WAS NO RESIDUAL ASTIGMATISM.
Patient problems: Visual Impairment
MAUDE report 23726670 ↗InjuryOct 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE IOL WAS EXCHANGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Insufficient Information; Visual Impairment
MAUDE report 23390857 ↗
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.
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