TECNIS IOL DFW225 (REF DFW225U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751781), received between Jun 27, 2022 and Feb 9, 2023 — classified as 3 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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW225 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). PATIENT REPORTS COMPLAINTS OF INABILITY TO DRIVE AT NIGHT WITHIN DAYS OF FIRST SURGERY. THERE WAS NO PATIENT INJURY. IOL EXPLANT IS SCHEDULED FOR (B)(6) 2023. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 16344478 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW225 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). PATIENT REPORTS COMPLAINTS OF INABILITY TO DRIVE AT NIGHT WITHIN DAYS OF FIRST SURGERY. THERE WAS NO PATIENT INJURY. IOL EXPLANT IS SCHEDULED FOR (B)(6) 2023 AND THE PLANNED REPLACEMENT LENS IS A NON-JOHNSON & JOHNSON SURGICAL VISION 16.0 DIOPTER LENS. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 16343934 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL), MODEL: DFW225 WITH 16.5 DIOPTER POWER, WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE. THE IOL WAS REPORTED TO BE WELL CENTERED; HOWEVER, DUE TO COMPLAINTS OF OVERCORRECTED TARGET AND BLURRY VISION, PLANO -125X78, THE LENS WAS EXPLANTED AND REPLACED WITH A DFW150 MODEL IOL WITH 17.0 DIOPTER POWER. PATIENT VISUAL ACUITY PRE-OPERATIVE WAS REPORTED AS: 20/80. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 14831641 ↗