TECNIS IOL DFW150 (REF DFW150U145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474751156), received between Apr 4, 2022 and Jun 8, 2023 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 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 PATIENT'S RIGHT EYE SINCE THE PATIENT COULD NOT SEE NEAR OR DISTANCE ENOUGH. THE PATIENT DID NOT HAVE ANY PRE-EXISTING MEDICAL HISTORY ISSUES AND DID NOT HAVE DEBILITATING CONDITION. A NON-JOHNSON &JOHNSON LIGHT ADJUSTABLE LENS OF 14 DIOPTER WAS USED AS A REPLACEMENT LENS. IT WAS INDICATED THAT THERE WAS CAPSULE TEAR, AND AN UNPLANNED VITRECTOMY WAS PERFORMED. THE PATIENT OUTCOME WAS REPORTED TO BE OK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; Visual Impairment

  MAUDE report 17093265 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO HEADACHES, LIGHT SENSITIVITY AND BLURRY VISION. ANOTHER COMPETITOR LENS WAS USED AS THE REPLACEMENT IOL. THERE WAS NO PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD DURING POST-OPERATION DAY 1 VISIT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Headache; Visual Disturbances

  MAUDE report 14004605 ↗