TECNIS IOL DFW150 (REF DFW150U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474751262), received between Aug 11, 2021 and Jan 26, 2026 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Adverse Event Without Identified Device or Use Problem

  THE DFW150 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DURING THE INITIAL IMPLANTATION, THE IOL DIRECTIONS FOR USE WERE ADHERED TO. POST-OPERATIVELY, THE PATIENT THE REPORTED BEING UNHAPPY WITH HIS VISION AT COMPUTER DISTANCE. BEST CORRECTED VISUAL ACUITY (BCVA) PRE-OPERATIVE WAS 20/20 AND POST-OPERATIVE WAS 20/16. THE PATIENT WAS TEMPORARILY IMPAIRED, THUS THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DXW150 20.0 IOL. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. PATIENT PROGNOSIS POST IOL EXPLANT WAS REPORTED AS GOOD AND VISUAL ACUITY WAS 20/13. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 24178258 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED FROM THE PATIENT'S LEFT EYE DUE TO DYSPHOTOPSIA. THIS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 17722572 ↗
• InjurySep 16, 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 IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS DUE TO COMPLAINTS OF SUBOPTIMAL BEST CORRECTED VISUAL ACUITY (BCVA), BLURRED VISION, AND DIFFICULTLY SEEING DISTANT AND CLOSE OBJECTS. IT WAS REPORTED DAILY ACTIVITIES ARE SIGNIFICANTLY AFFECTED AND THE PATIENT IS A PILOT. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), AND NO VITRECTOMY. PATIENT WAS PRESCRIBED KETORALAC, PREFORTE AND GATIFLOXACIN WHICH WAS CONFIRMED TO BE PATIENTS STANDARD OF CARE AFTER SURGERY. IT WAS CONFIRMED PATIENT DAILY ACTIVITIES ARE NO LONGER SIGNIFICANTLY AFFECTED AFTER IOL EXPLANT. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED AND PATIENT IS HAPPY WITH THE SURGERY. IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Discomfort

  MAUDE report 15442853 ↗
• InjuryMay 12, 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 AS THE VISION WAS NOT CLEAR. ANOTHER COMPETITOR LENS OF SAME DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO OTHER PATIENT INJURY AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST OPERATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14384218 ↗
• InjuryMar 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IOL WAS EXPLANTED FROM THE LEFT EYE DUE TO HALOS. THE ISSUE WAS OBSERVED DURING POST-OPERATIVE EXAMINATION. ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL ZCB00, DIFFERENT DIOPTER 21.5) WAS IMPLANTED AS REPLACEMENT. THE INCISION WAS ENLARGED TO REMOVE THE IOL FROM THE EYE. NO SUTURES OR VITRECTOMY REQUIRED. THERE WAS NO DELAY IN PROCEDURE. THERE WAS NO ADDITIONAL SURGICAL OR MEDICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. THE PATIENT'S PRE-OPERATIVE VISUAL ACUITY WAS 20/40, AND POST-OPERATIVE VISUAL ACUITY IS 20/20. THE PATIENT IS DOING WELL AFTER THE EXCHANGE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo

  MAUDE report 13716872 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE, THE PATIENT VISION WAS STILL VERY BLURRY WITH LOTS OF HALOS. THE PATIENT HAD THE IOL EXPLANTED. ANOTHER JOHNSON AND JOHNSON IOL (SAME MODEL, DIFFERENT DIOPTER, 20.5) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTIONS AND NO PATIENT INJURY. PLANNED INTERVENTIONS INCLUDE FOLLOW-UP WITH MEIBOMIAN GLAND DYSFUNCTION OD, EPIRETINAL MEMBRANE (ERM) OD, BAND KERATOPATHY OD, AND PSEUDOPHAKIA OD. THE PATIENT'S VISION IS CLEARING UP AND THERE IS NO PAIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Halo

  MAUDE report 13690773 ↗
• InjuryJan 12, 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 PATIENT COMPLAINT OF DISTORTED NOT CLEAR VISION TO RIGHT EYE. THE LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON (PANOPTIX) IOL. THE PATIENT IS HAPPY WITH THE NEW LENS. NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES WERE REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo

  MAUDE report 13238956 ↗
• InjurySep 3, 2021Adverse 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 DUE TO BLURRY VISION AT ALL DISTANCES. THE CUSTOMER INDICATED THAT LENS HAD BEEN DISCARDED. ANOTHER JOHNSON & JOHNSON LENS ZXT150 DIOPTER 20.5 (DIFFERENT MODEL AND HIGHER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 12423746 ↗
• InjuryAug 11, 2021Adverse 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 PATIENT'S RIGHT EYE AS THE PATIENT WAS NOT A GOOD CANDIDATE DUE TO IRREGULAR ASTIGMATISM AND WAS HAVING CONSTANT GLARE. THE PRE-OPERATIVE VISUAL ACUITY WAS 20/40 AND POST-OPERATIVE VISUAL ACUITY WAS 20/25. THE DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. HOWEVER, SUTURES WERE REQUIRED AND THERE WAS A DELAY OF 1 HOUR. ANOTHER JOHNSON & JOHNSON LENS ZCB00 MODEL, BUT SAME DIOPTER WAS PLACED AS THE REPLACEMENT (SN (B)(4)). NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 12310913 ↗