TECNIS IOL DFW150 (REF DFW150U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751187), received between Jan 11, 2022 and Dec 8, 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.

• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT AFTER IMPLANTING AN INTRAOCULAR LENS (IOL) INTO THE PATIENT¿S LEFT EYE THEY EXPERIENCED HALOS AND CAPSULAR PHIMOSIS. THE DOCTOR NOTICED THE CAPSULAR PHIMOSIS WHEN THEY WERE EXPLANTING THE IOL. THE IOL WAS REPLACED WITH A DIFFERENT MODEL AND DIOPTER DIU150 15.0. THE EXPLANTED IOL WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Contracture; Halo

  MAUDE report 15944555 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA SYMPTOMS IN THE LEFT EYE RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE NEEDED. A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING WELL AT POST-OPERATIVE DAY ONE. IT WAS REPORTED THAT THE IOL IS NOT AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 14839111 ↗
• InjuryJan 11, 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 PATIENTS LEFT EYE DUE TO PATIENT EXPERIENCING GLARE AND A THUMBPRINT CONSTANTLY OVER HER VISION. THE IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON LENS. THERE WERE NO SURGICAL OR MEDICAL INTERVENTIONS SUCH AS INCISION ENLARGEMENT, CAPSULE TEAR, VITRECTOMY OR SUTURES. THERE WAS NO PATIENT INJURY. REPORTEDLY, THE PATIENT IS DOING OK POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 13233657 ↗