TECNIS IOL DFW150 (REF DFW150U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751194), received between Feb 18, 2022 and May 10, 2022 — 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. 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.

• InjuryMay 10, 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 IN A SECONDARY SURGICAL PROCEDURE DUE TO REFRACTIVE SURPRISE ISSUE. IT WAS INDICATED THAT ANOTHER JOHNSON & JOHNSON LENS WITH THE SAME MODEL AND DIOPTER WAS USED. THERE WERE NO MEDICAL OR SURGICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES REPORTED. THE PATIENT IS DOING FINE POST-OPERATION AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 14344120 ↗
• InjuryMar 8, 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 DUE TO BOTHERSOME GLARE AND HALOS WHEN DRIVING AT NIGHT. IT WAS STATED THAT THE PATIENT REQUESTED THE SUSPECT IOL TO BE REMOVED. ACCOUNT INDICATED THAT THE LENS WAS REPLACED WITH A DIB00 IOL; HOWEVER, NO DIOPTER SIZE OR SERIAL NUMBER PROVIDED. THE LENS WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13699658 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYNERGY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE. THE PATIENT WAS UNHAPPY WITH THE IOL AND COMPLAINED OF GLARE/HALOS AND "BEAMS/RODS OF LIGHT AT NIGHT" MAKING DRIVING AT NIGHT DIFFICULT. THE PATIENT STATED IT STARTED FROM THE BEGINNING OF THE IMPLANT AND HAS TRIED TO OVERCOME VISUAL ISSUES. ANOTHER JOHNSON & JOHNSON DIU150 LENS (DIFFERENT MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. NO OCULAR COMPLAINTS AT FIRST POST-OPERATIVE VISIT AFTER LENS EXCHANGED, THE PATIENT ENDED UP WITH 20/25 WITHOUT CORRECTION VISION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 13563847 ↗