TECNIS IOL DFR00V (REF DFR00VU150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474750579), received between Jul 21, 2021 and Mar 7, 2024 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT¿S RIGHT EYE AS THE PATIENT HAD VERY SYMPTOMATIC GLARE, HALO, AND STARBURST. THE ISSUE WAS FIRST NOTED DURING THE POST-OPERATIVE EXAMINATION. NO OTHER SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED AND NO DELAY IN PROCEDURE REPORTED. ANOTHER JOHNSON & JOHNSON LENS FROM DIFFERENT MODEL (ZCB00) BUT OF THE SAME DIOPTER WAS USED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATION AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 18862511 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THEM EXPERIENCING GLARE. THE EXPLANTED IOL WAS DISCARDED. THE REPLACEMENT LENS IS A DIFFERENT MODEL DIU225 +14.5 DIOPTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16492661 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO GLARE AND HALOS. A COMPETITOR'S LENS WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13797494 ↗
• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT ENDED UP OU 20/20 J1, BUT COULD NOT TOLERATE GLARE AND HALO AFTER THE IMPLANTATION OF THE SYNERGY INTRAOCULAR LENSES (IOLS) IN BOTH EYES. THE LENSES WERE REMOVED AND REPLACED WITH NON-JOHNSON AND JOHNSON LENSES AFTER THE 1-MONTH POST-OP APPOINTMENT. THE EXPLANTED IOLS WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT REPRESENTS THE RIGHT (OD) EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT (OS) EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13511675 ↗
• MalfunctionJul 21, 2021Scratched Material; Scratched Material

  IT WAS REPORTED THAT A DFR00V MODEL INTRAOCULAR LENS(IOL) HAD A DENT . THERE WAS NO PATIENT CONTACT. THE EVENT WAS OBSERVED DURING HANDLING BUT PRIOR TO INSERTION INTO EYE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12207735 ↗