Clareon CNW0T3 (UDI 00380652409612)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380652409612), received between Sep 25, 2024 and Aug 10, 2026 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50192988 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FACILITY REPRESENTATIVE REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, LENS WAS EXPLANTED AT SECONDARY PROCEDURE DUE TO PATIENT REASON NOT SATISFIED WITH THE VISION OUTCOME. THE CLINICAL REASON FOR EXPLANT WAS REPORTED TO BE PATIENT DISSATISFIED WITH VISUAL OUTCOME. THE IOL WAS REPLACED WITH UNSPECIFIED LENS FOUR MONTHS AFTER INITIAL PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Blurred Vision

  MAUDE report 23790313 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A NON-HEALTH CARE PROFESSIONAL REPORTED THAT FOLLOWING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLURRED VISION IN THE RIGHT EYE, POOR VISUAL ACUITY AT DISTANCE WHICH RESULTED IN THE PATIENT BEING UNABLE TO DRIVE AT NIGHT. THE IOL FELT GRITTY. ADDITIONAL INFORMATION WAS RECEIVED BY STATING, CLINICAL REASON BEING MENTIONED AS POOR VISUAL ACUITY AT DISTANCE. THE IOL WAS EXPLANTED AND EXCHANGED WITH AN UNSPECIFIED ATIOL (ADVANCED TECHNOLOGY INTRAOCULAR LENS) IN THE SECONDARY IMPLANT PROCEDURE.

  Patient problems: Blurred Vision; Foreign Body Sensation in Eye

  MAUDE report 23366277 ↗
• MalfunctionSep 25, 2024Scratched Material; Scratched Material

  A HEALTH CARE PROFESSIONAL REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, SOMETHING LIKE A SCRATCH WAS FOUND ON THE OPTICAL SURFACE AFTER IMPLANTATION. THE SURGERY WAS COMPLETED WITHOUT PRODUCT REPLACEMENT AND THE LENS REMAINS IN THE PATIENT'S EYE. THERE WAS NO VISUAL LOSS AND NO PATIENT HARM. THE INCISION SIZE WAS 2.4 MM. THERE ARE SIX MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 4 OF 6.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20305059 ↗