TECNIS IOL DFW375 (REF DFW375U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05050474752986), received between May 6, 2022 and May 6, 2022 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A MODEL DFW300 INTRAOCULAR LENS (IOL) IN THE LEFT EYE (OS), AND A MODEL DFW375 IOL IN THE RIGHT EYE (OD) IN (B)(6) 2021. IN (B)(6) 2022 THE PATIENT COMPLAINED OF EXCESSIVE DYSPHOTOPSIA IN BOTH EYES, AFFECTING THEIR ABILITY TO PERFORM ACTIVITIES THEY PREVIOUSLY CONDUCTED. A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS PERFORMED ON BOTH EYES IN (B)(6) 2022. THE PATIENT CONTINUED TO BE UNHAPPY AFTER THE YAG PROCEDURE. PATIENT¿S CURRENT VISION IS REPORTED AS 20/25 DISTANCE, 20/100 INTERMEDIATE, AND 20/25 NEAR. THERE HAS BEEN NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION REQUIRED AT THIS TIME, AND THERE ARE NO REPORTED PRE-EXISTING MEDICAL CONDITIONS. PRODUCT IS NOT AVAILABLE FOR EVALUATION AS THE IOLS REMAIN IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT IS TO CAPTURE THE EVENT FOR THE RIGHT EYE (OD). A SEPARATE REPORT IS BEING SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Discomfort; Visual Disturbances

  MAUDE report 14312559 ↗