Clareon CNW0T4 (UDI 00380652410007)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380652410007), received between Jul 25, 2024 and Apr 10, 2026 — classified as 1 injury, 2 malfunctions.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) IMPLANTATION SURGERY, THE LENS WAS ROTATED TO 30 OR 40 DEGREE ON POST OPERATIVE DAY 1. THE LENSES WAS IMPLANTED ON HIGH MYOPE PATIENTS WITH VERTICAL LENS PLACEMENT. IN 2 OF 3 CASES A CAPSULAR TENSION RING WAS USED DURING THE SURGERY TO REDUCE THE ROTATION OF THE LENS IN THESE PATIENTS HOWEVER, THE LENS WAS NOT ROTATED IN ONE EYE AND IT WAS ROTATED IN OTHER EYES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, YET NO NEW INFORMATION RECEIVED. THERE ARE THREE FILES ASSOCIATED WITH THIS REPORT. THIS IS 2 OF 3.

  Patient problems: Insufficient Information

  MAUDE report 24839816 ↗
• MalfunctionMar 30, 2026Device Dislodged or Dislocated

  A PHYSICIAN REPORTED THAT AFTER AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE, THE LENS WAS ROTATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THE TIME OF THIS REPORT. THERE ARE THREE MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS REPORT. THIS IS 1 OF 3.

  Patient problems: Insufficient Information; Visual Impairment

  MAUDE report 24728616 ↗
• InjuryJul 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A FACILITY REPORTED THAT DURING AN INTRAOCULAR LENS (IOL) IMPLANT PROCEDURE , THE PATIENT HAD A 12.0 LENS IMPLANTED INSTEAD OF THE PLANNED 16.0D LENS. ON DAY OF SURGERY, LENS WAS VERIFIED BUT THE OUTSIDE LENS BOX WAS LABELED CORRECTLY. THE PATIENT HAD DECREASED VISION AND THE LENS WAS EXPLANTED AND EXCHANGED WITH 16.5D LENS. ADDITIONAL INFORMATION RECEIVED THAT CLINICAL REASON FOR EXPLANT WAS MENTIONED AS THERE WAS NO IMPROVEMENT IN VISION AFTER ONE MONTH RECORDS WAS CHECKED AND WRONG SIZE LENS HAD BEEN PLACED.

  Patient problems: Blurred Vision

  MAUDE report 19828772 ↗