Clareon CNWET3 (UDI 00380652466363)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652466363), received between May 6, 2025 and Mar 9, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Product Quality Problem” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Product Quality Problem

  A NONHEALTH CARE PROFESSIONAL REPORTED THAT DURING THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS FOUND TO BE DEFECTIVE.

  Patient problems: Insufficient Information

  MAUDE report 24547186 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, PATIENT EXPERIENCED PRESBYOPIA WHICH WAS NOT CORRECTED AT ALL AND THE PATIENT CANNOT READ WITHOUT ADDITIONAL GLASSES. ASTIGMATISM WAS NOT CORRECTED AND THE VISION HAS WORSENED, PREVIOUSLY PATIENT COULD WORK ON THE COMPUTER WITHOUT GLASSES BUT NOW GLASSES ARE NEEDED. A STRIPE HAS APPEARED IN THE VISUAL FIELD ON THE LEFT EYE FROM THE BRIDGE OF THE NOSE TO THE OUTER CORNER OF THE EYE, PATIENT WANTED TO BRUSH THE STRIPE AWAY AS IF IT WERE A HAIR. ADDITIONAL INFORMATION WAS RECEIVED AND STATED, ON (B)(6) 2024 IOL WAS IMPLANTED IN THE LEFT EYE. TWO HOURS AFTER THE SURGERY, AFTER REMOVING THE BANDAGE FROM THE EYE, THE FIRST THING PATIENT SAW WAS A YELLOW ARCUATE STRIPE, WHICH WAS LOCATED IN THE FIELD OF VISION OF THE LEFT EYE AND EXTENDED FROM THE BRIDGE OF THE NOSE TO THE OUTER CORNER OF THE LEFT EYE. FROM THAT MOMENT UNTIL NOW, THIS STRIPE HAS BEEN CONSTANTLY PRESENT IN THE FIELD OF VISION OF THE LEFT EYE. IT DOES NOT SHIFT ANYWHERE, NEVER DISAPPEARS AND DOES NOT DEPEND ON THE TIME OF DAY AND LIGHTING AND DOES NOT DEPEND ON HOW PATIENT ADJUST THE EYE, TO A CLOSE DISTANCE OR TO A DISTANCE. ON

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 21970259 ↗