TECNIS IOL DFR00V (REF DFR00VU155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474750586), received between Apr 19, 2022 and Dec 27, 2023 — classified as 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS WAS EXPLANTED IN THE SECONDARY PROCEDURE AS THE PATIENT WAS VERY UNHAPPY, DUE TO GLARE, HALOS AND SPIDER WEBS IN VISION. THE ISSUE WAS FIRST OBSERVED DURING POST-OP EXAM. THE PRE-OP VISUAL ACUITY WAS 20/40 AND THE POST-OP VISUAL ACUITY WAS 20/20. THERE WAS NO INCISION ENLARGEMENT, SUTURES, VITRECTOMY, NO DELAY IN TREATMENT. THROUGH ADDITIONAL INFORMATION IT WAS LEARNED THAT THE DFR00 LENS WAS EXPLANTED FROM THE PATIENTS RIGHT EYE AND REPLACED WITH DIB00 +16.0D LENS. THE PATIENT OUTCOME WAS REPORTED AS MUCH BETTER WITH NO GLARES AND NO BLURRY VISION. THERE WAS NO OTHER PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTION REQUIRED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances; Vitreous Floaters

  MAUDE report 18399060 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MULTIFOCAL INTRAOCULAR LENS HAD BEEN EXCHANGED AND REMOVED. ADDITIONAL INFORMATION REVEALED THAT THE PATIENT'S VISION WAS DECREASING ALONG WITH OTHER VISUAL DISTURBANCES, INCLUDING NIGHT DRIVING. THE LENS WAS REMOVED AND REPLACED WITH ANOTHER COMPANY LENS. THERE WAS NO INJURY, AND SURGICAL AND MEDICAL INTERVENTIONS REQUIRED. THE PRODUCT IS BEING RETUNED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 18349972 ↗
• InjuryMar 3, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THE DFR00V 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO COMPLAINTS OF MECHANICAL FAILURE. THERE WAS NO PATIENT INJURY, NO SUTURE(S), AND NO VITRECTOMY HOWEVER A NEW INCISION WAS CREATED. REPLACEMENT LENS INFORMATION AND PATIENT STATUS POST-LENS EXCHANGE ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16479926 ↗
• InjuryNov 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING ONE DAY POST-OP EXAM DFR00 INTRAOCULAR LENS IOL) WAS EXPLANTED DUE TO A MECHANICAL FAILURE. THE INCISION WAS ENLARGED AND A VITRECTOMY WAS PERFORMED. NO SUTURES WERE USED. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15887709 ↗
• InjurySep 20, 2022Adverse 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 A PATIENT'S RIGHT EYE AS THE PATIENT COMPLAINED OF BLURRY VISION. THE PATIENT DID NOT HAVE A "DEBILITATING CONDITION", BUT THE AMOUNT OF BLURRINESS HE EXPERIENCED IN HIS RIGHT EYE HAD AFFECTED/IMPACTED HIS READING, READING ROAD SIGNS AND WATCHING TV TO BE NOT AS CLEAR AS IT SHOULD HAVE BEEN. A PLANNED/EXPECTED VITRECTOMY WAS PERFORMED AS THE PATIENT HAD AN YTTRIUM-ALUMINUM-GARNET (YAG) PROCEDURE ON (B)(6) 2022; THEREFORE THEIR POSTERIOR CAPSULE WAS NOT INTACT AND SINCE THE PATIENT PRESENTED WITH 1+ 2+ POSTERIOR CAPSULAR OPACIFICATION (PCO)/SECONDARY MEMBRANE; SYNERGY MULTIFOCAL CENTERED PC IOL. IT WAS CONFIRMED THAT THERE WAS NO CAPSULE TEAR ISSUE. A NON-JOHNSON AND JOHNSON LENS WAS USED WAS USED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OP AND NO INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision

  MAUDE report 15459972 ↗
• MalfunctionApr 19, 2022Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) MALFUNCTIONED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14150353 ↗