TECNIS IOL DFR00V (REF DFR00VU145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474750562), received between Jul 7, 2022 and Apr 25, 2025 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 25, 2025Adverse 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 FROM THE PATIENT¿S RIGHT EYE. THE REASON FOR THE EXPLANT IS THAT THE PATIENT¿S DISTANCE AND INTERMEDIATE VISION HAS NEVER BEEN CLEAR AFTER THE IMPLANT. THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH THE PATIENT¿S DAILY ACTIVITIES. PRE-OPERATIVE UNCORRECTED AND BEST CORRECTED VISUAL ACUITY IS REPORTED AS 20/80. THEIR POST-OPERATIVE UNCORRECTED AND BEST CORRECTED VISUAL ACUITY IS NOT AVAILABLE SINCE THE PATIENT HAS ONLY BEEN SEEN FOR A SAME DAY POST OP AND THEIR NEXT VISIT IS IN MAY. REPORTEDLY, THERE WERE NO PATIENT INJURIES SUCH AS A CAPSULE TEAR. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 21914947 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT EXPRESSED DISSATISFACTION WITH AN INTRAOCULAR LENS THAT HAD BEEN IMPLANTED IN THEIR LEFT EYE. THE PATIENT REPORTED EXPERIENCING POOR NEAR VISION AND DIFFICULTY SEEING COMPARED TO THEIR PRE-SURGERY VISION. THE PATIENT INITIALLY COMPLAINED OF EXPERIENCING HALOS AND NIGHT GLARE, WHICH SIGNIFICANTLY INTERFERED WITH THEIR DAILY ACTIVITIES. THE LENS WAS EXPLANTED AND REPLACED WITH A DIB00 LENS. THE PATIENT'S POST-OPERATIVE UNCORRECTED AND BEST CORRECTED VISUAL ACUITY WAS 20/25, AND NO OTHER INJURIES OR MEDICAL INTERVENTIONS WERE NECESSARY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Halo; Visual Disturbances

  MAUDE report 16854723 ↗
• InjuryJan 20, 2023Adverse 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 FROM THE LEFT EYE DUE TO BLURRED VISION AND GLARES. THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH DAILY ACTIVITIES. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 16216163 ↗
• InjuryNov 28, 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 THE PATIENT'S LEFT EYE DUE TO SUBJECTIVE VISUAL DISTURBANCES. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE PATIENT HAS FULLY RECOVERED. THROUGH FOLLOW UP, IT WAS LEARNED THAT ANOTHER JOHNSON & JOHNSON LENS, MODEL DIB00 17.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 15874754 ↗
• InjuryNov 17, 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 FROM THE PATIENT'S LEFT EYE (OS). THE IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON 15.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 15815436 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED A REPORT INDICATING THE PATIENT IS EXPERIENCING BLURRY VISION AT DISTANCE. THE HEALTH CARE PROVIDER INDICATED THE SYMPTOM IS DEBILITATING. THE IOL WAS EXPLANTED AND REPLACED WITH THE SAME MODEL BUT 15.0 DIOPTER. REPORTEDLY, THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY OR SUTURES REQUIRED. THE PATIENT IS NOT ON ANY MEDICATION OUTSIDE OF THE STANDARD OF CARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14952486 ↗