TECNIS IOL DFR00V (REF DFR00VU135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474750548), received between Dec 9, 2021 and Apr 24, 2024 — classified as 4 injuries, 1 malfunction.

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

• InjuryApr 24, 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 THE PATIENT'S OPERATIVE EYE. THE REASON FOR EXPLANT WAS NOT SPECIFIED. A NON-JOHNSON AND JOHNSON IOL WAS USED AS A REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 19173557 ↗
• InjuryJun 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE DUE TO DISLOCATION, HALOS, AND BALANCE ISSUES. THE PATIENT DID NOT HAVE A DEBILITATING CONDITION DUE TO THESE ISSUES. THE PATIENT DOES NOT HAVE ANY PRE-EXISTING MEDICAL HISTORY ISSUES. A NON-JOHNSON AND JOHNSON LIGHT ADJUSTABLE LENS (LAL) WAS IMPLANTED. NO ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT IS ¿OK¿ POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Insufficient Information

  MAUDE report 17135960 ↗
• MalfunctionMay 11, 2023Break; Break

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) HAD A BENT/BROKEN HAPTIC. THE ISSUE WAS NOTICED DURING HANDLING OF THE DEVICE AND PRIOR TO INSERTION. THERE WAS NO CONTACT WITH THE PRODUCT. THE PROCEDURE WAS COMPLETED USING A BACKUP DEVICE OF THE SAME MODEL AND DIOPTER. THE OUTCOME OF THIS EVENT DID NOT INTERFERE WITH THE PATIENT¿S DAILY ACTIVITIES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916675 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DFR00V INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS HE HAD CAPSULAR CATARACTS IN BOTH EYES; NO MACULAR ISSUES OR ANY OTHER HEALTH ISSUES. HE WAS TOLD HIS EYE PRESSURE IS AT 26 MM HG AND THE DOCTOR IS WANTING IT TO DROP TO 22 MM HG, BUT HE DOES NOT FEEL AS THOUGH HIS EYE IS SWOLLEN. ALPHAGAN, PROLENSA, BESIVANCE, AND INVELTYS WAS PRESCRIBED BY THE DOCTOR, TWICE PER DAY. PATIENT'S VISION IS WORSE THAN PRIOR TO THE CATARACT SURGERY AND HE FEELS HE WAS NOT PROPERLY EDUCATED ABOUT THE LENS THE DOCTOR WAS IMPLANTING. PATIENT EXPRESSED THAT HIS VISION IS MILKY, WAXY AND HAZY, WITH A BLURRY OR SMEARED LOOK TO EVERYTHING. HE SAID IT IS LIKE HAVING CATARACTS BUT WORSE. HE IS ABLE TO SEE PIXELS ON THE COMPUTER SCREEN WITH HIS NATURAL EYE (RIGHT EYE), BUT THERE IS NO CLARITY AT ALL WITH THE IMPLANTED EYE. PATIENT STATED HE WAS WARNED HE MAY EXPERIENCE HALOS AND STARBURSTS WHILE DRIVING, BUT HE SEES IT WHEN LOOKING AT THE COMPUTER SCREEN, REGARDLESS IF IT IS IN DARK OR LIGHT MODE. IN ADDITION, HE CANNOT SEE CLOSE UP AND SAID IT HURTS HIS ABILITY TO WORK, DRIVE AND USE HIS PHONE. THE PATIENT IS A GRAPHIC ARTIST AND ASSEMBLES COMPUTER PARTS; HE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Flashers; Halo; Insufficient Information; Intraocular Pressure Increased; Visual Disturbances

  MAUDE report 14651284 ↗
• InjuryDec 9, 2021Adverse 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 LEFT EYE DUE TO HALOS AND GLARES. A NON-JOHNSON & JOHNSON LENS WAS USED AS THE REPLACEMENT. THE INCISION WAS SLIGHTLY ENLARGED; HOWEVER, NO SUTURES WERE REQUIRED. THE PROCEDURE WAS COMPLETED AS PLANNED AND NO PATIENT INJURY WAS REPORTED. IT WAS INDICATED THAT THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12968861 ↗