TECNIS IOL DFR00V (REF DFR00VU085)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474750449), received between Feb 14, 2022 and Apr 26, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 26, 2023Break; Labelling, Instructions for Use or Training Problem; Break; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE SURGEON HAD ISSUE WITH AN INTRAOCULAR LENS. ADDITIONAL INFORMATION RECEIVED REVEALED THAT THE LENS WAS NOT BEING RETURNED, IT WAS BROKEN IN TRYING TO UTILIZE THE INSERTION TOOL. THE SURGEON COMPLAINED THAT THERE WAS NO CLEAR INSTRUCTIONS ON HOW TO DELIVER THE LENS AND IT BROKE. THE LENS WAS DISCARDED. UPON FURTHER FOLLOW UP, IT WAS INFORMED THAT THERE WAS NO PATIENT CONTACT AND IT WAS CONFIRMED THAT THE LENS DID BREAK WHILE TRYING TO USE INSERTER. THERE WAS A POSSIBLE USE ERROR WHILE HANDLING THE LENS AND NO DIRECTIONS FOR USE WERE MENTIONED. THE SURGEON HAD ISSUES WITH THE LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817753 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO A MECHANICAL FAILURE. A VITRECTOMY AND AN INCISION ENLARGEMENT WERE REQUIRED, HOWEVER, THERE WERE NO SUTURES NEEDED. THERE WAS NO PATIENT INJURY. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE MECHANICAL ISSUE WAS DUE TO THE PATIENT REPORTING CONSTANT BLURRED VISION AT ALL FOCAL POINTS AND CONSTANT HALOS WITH VISION, ESPECIALLY WITH NIGHT DRIVING. THE HALOS WERE SO SEVERE, THE PATIENT REPORTED SHE FELT UNSAFE DRIVING. A NON-JOHNSON & JOHNSON LENS WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT IS STABLE POST-OPERATIVELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 16308471 ↗
• MalfunctionFeb 14, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS THE IOL WAS REMOVED DURING THE SAME PROCEDURE AS THE LENS WAS SCRATCHED. ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY. THE OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT'S POST-OPERATIVE OUTCOME WAS NOT AVAILABLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13529384 ↗