Clareon CNWET3 (UDI 00380652466400)Recalls & reported problems
Alcon Laboratories, Inc. · Clareon Vivity Toric · Class 3 · Implant
All models of Clareon (1142)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652466400), received between Oct 18, 2024 and Aug 11, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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
- Device Dislodged or Dislocated2
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Split, Cut or Torn1
Patient problems
- Blurred Vision1
- Inflammation1
- Insufficient Information1
- Iritis1
- Visual Disturbances1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
A PHYSICIAN REPORTED THAT FOLLOWING THE INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SHE EXPERIENCED DECREASED VISION WHILE DRIVING AT NIGHT DUE TO GLARE AND ALSO DIM VISION, HAD TROUBLE SEEING STAIRS AT HOME IN LOW LIGHT. PATIENT FELT VISION WAS GOOD. THE LEFT EYE WAS SCHEDULED PRIOR CHOOSING IOL AND THOUGHT UNOPERATED EYE COULD SEE BETTER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Patient problems: Blurred Vision; Iritis; Visual Disturbances
MAUDE report 22773110 ↗MalfunctionFeb 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
HEALTH CARE PROFESSIONAL REPORTED WITH A DESCRIPTION OF BROKEN WHILE LOADING.
Patient problems: Insufficient Information
MAUDE report 21410411 ↗InjuryOct 18, 2024Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated
A HEALTHCARE PROFESSIONAL REPORTED DURING INTRAOCULAR LENS (IOL) IMPLANTATION PROCEDURE, WHEN PERFORMING THE LENS INJECTION, THE SECOND HAPTIC IS BROKEN IN HALF. THE LENS WAS RETAINED IN EYE. ADDITIONAL INFORMATION WAS RECEIVED STATING THE PHYSICIAN PRESCRIBED NON-STEROIDAL ANTI-INFLAMMATORY DRUG DROPS TO RELIEVE THE INFLAMMATION. THERE WAS A SLIGHT DISLOCATION OF THE IOL. THEY ARE WAITING TO SEE THE EVOLUTION OF CLOSE VISION TO VERIFY THE NEED FOR AN EXPLANT.
Patient problems: Inflammation
MAUDE report 20479067 ↗
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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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