TECNIS IOL DFR00V (REF DFR00VU250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474750777), received between Jan 14, 2022 and Jun 25, 2024 — classified as 2 injuries.

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.

• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO UNSPECIFIED REASONS. THE REPLACEMENT LENS IS THE SAME JNJ MODEL DFR00V DIFFERENT DIOPTER 24.0 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19611268 ↗
• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AT A LATER DATE DUE TO THE PATIENT NOT BEING ABLE TO ADAPT POST IOL IMPLANTATION IN THEIR LEFT EYE. THE REPLACEMENT IOL WAS A NON-JOHNSON & JOHNSON LENS. THROUGH FOLLOW-UP, IT WAS LEARNED THAT PATIENT VISUAL ISSUES WERE BLURRY VISION, HALOS, GLARE DRIVING AT NIGHT, AND READING. NO FURTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. PATIENT VISUAL OUTCOME POST-LENS EXCHANGE WAS REPORTED AS 20/40 SC (WITHOUT CORRECTION) / 20/25 WITH MANIFEST REFRACTION (MR). NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 13261527 ↗