Clareon CNW0T6 (UDI 00380652411264)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380652411264), received between Jan 12, 2026 and Jan 12, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 18, 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.

• MalfunctionJan 12, 2026Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WITH THESE TWO IOL¿S, THEY WERE LOADED BY TWO DIFFERENT TECHS, WITH A DIFFERENT CARTRIDGE, AND A DIFFERENT INJECTOR EACH TIME (IN THE SAME PATIENT). THEY WERE PERFORMED ON THE SAME PATIENT, USING THE SAME ( TORIC & SPHERE) IOL POWER & MODEL WITH, I BELIEVE, THE SAME REFERENCE NUMBERS. AS THEY DIDN¿T HAVE A THIRD IOL OF THAT POWER, THEY OBTAINED A PRELOADED TORIC IOL OF THE SAME POWER BUT THE COLORLESS VERSION. ON THE INITIAL ATTEMPT TO PLACE IN THE PATIENT, IT WAS INADVERTENTLY INJECTED OUTSIDE OF THE PATIENT¿S EYE. THEREFORE, IT HAD TO BE MANUALLY LOADED AND THEN INJECTED WHICH PROCEEDED UNEVENTFULLY. THE FIRST IOL HAD THE TIP OF THE OF THE LEADING HAPTIC TRUNCATED OFF, THE TRAILING HAPTIC BROKE SUCH THAT TWO SEPARATE PIECES OF THE HAPTIC BROKE OFF, AND THE EDGE OF THE IOL OPTIC AND SURFACE OF THE IOL HAD SOME DAMAGE. THE SECOND IOL INJECTED, AND THE OPTIC WAS CUT NEARLY COMPLETELY IN HALVES DOWN THE MIDDLE OF THE OPTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24043638 ↗
• MalfunctionJan 12, 2026Material Split, Cut or Torn

  A NURSE REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, WITH THESE TWO IOL¿S, THEY WERE LOADED BY TWO DIFFERENT TECHS, WITH A DIFFERENT CARTRIDGE, AND A DIFFERENT INJECTOR EACH TIME (IN THE SAME PATIENT). THEY WERE PERFORMED ON THE SAME PATIENT, USING THE SAME ( TORIC & SPHERE) IOL POWER & MODEL WITH, I BELIEVE, THE SAME REFERENCE NUMBERS. AS THEY DIDN'T HAVE A THIRD IOL OF THAT POWER, THEY OBTAINED A PRELOADED TORIC IOL OF THE SAME POWER BUT THE COLORLESS VERSION. ON THE INITIAL ATTEMPT TO PLACE IN THE PATIENT, IT WAS INADVERTENTLY INJECTED OUTSIDE OF THE PATIENT¿S EYE. THEREFORE, IT HAD TO BE MANUALLY LOADED AND THEN INJECTED WHICH PROCEEDED UNEVENTFULLY. THE FIRST IOL HAD THE TIP OF THE OF THE LEADING HAPTIC TRUNCATED OFF, THE TRAILING HAPTIC BROKE SUCH THAT TWO SEPARATE PIECES OF THE HAPTIC BROKE OFF, AND THE EDGE OF THE IOL OPTIC AND SURFACE OF THE IOL HAD SOME DAMAGE. THE SECOND IOL INJECTED, AND THE OPTIC WAS CUT NEARLY COMPLETELY IN HALVES DOWN THE MIDDLE OF THE OPTIC. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 24043614 ↗