TECNIS IOL DFW150 (REF DFW150U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474751200), received between Jan 7, 2022 and Sep 11, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT¿S OPERATIVE EYE. THE CAPSULE TORE AND THE IOL WAS REMOVED. A VITRECTOMY WAS REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-JNJ LENS. THE DEVICE IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. THE CUSTOMER DECLINED TO PROVIDE PATIENT DEMOGRAPHIC INFORMATION DUE TO PATIENT PRIVACY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 17726563 ↗
• 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 PATIENTS OPERATIVE EYE DUE TO LACK OF NEAR VISION AND BLURRED VISION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 15874746 ↗
• InjuryNov 7, 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 LEFT EYE DUE TO "MISSED REFRACTION." ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, DIFFERENT DIOPTER OF 17.5). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PRODUCT IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 15749698 ↗
• InjuryJan 7, 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 POOR INTERMEDIATE AND NEAR VISON AND AS PATIENT COULD NOT SEE OUT OF THE EYE. IT WAS INDICATED THAT THE PATIENT DID NOT LIKE THE MULTIFOCALITY OF THE LENS AS PATIENT COULD NOT GET NEAR VISION AND DID NOT LIKE THE LENS. THE PATIENT¿S ISSUES WERE FIRST NOTICED 1-DAY POST OPERATION. THE DISTANCE VISION WAS REPORTED TO BE GOOD. THE INCISION WAS ENLARGED, AND THE EXPLANTED LENS CAME OUT IN ONE PIECE. A MONOFOCAL LENS, MODEL ZCU150 WITH 17.0 DIOPTER, WAS USED AS A REPLACEMENT. IT WAS NOTED THAT SUTURES WERE USED. THE PATIENT HAS REPORTEDLY FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 13196473 ↗