TECNIS IOL DFW150 (REF DFW150U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474751163), received between Apr 7, 2022 and Jun 19, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN THE PRELOADED INTRAOCULAR LES (IOL) WAS IMPLANTED, THE PATIENT HAD EXPERIENCED EXTREME DIFFICULTY WITH GLARES AND HALOS. IT WAS NOTED THAT PATIENT WAS AFFECTED WITH THE GLARES MAKING THE PATIENT "SCARED" TO DRIVE (DOESN'T DRIVE AS THE PATIENT IS SCARED). THE DOCTOR WILL EXPLANT THE LENS AND REPLACE WITH A MONOFOCAL LENS. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 19571423 ↗
• InjuryNov 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED SIX MONTHS AFTER THE INITIAL SURGERY BECAUSE OF THE INTOLERABLE DYSPHOTOPSIA THAT THE PATIENT WAS HAVING. THE ISSUE WAS FIRST IDENTIFIED DURING POST-OPERATIONAL EXAMINATION. ANOTHER JOHNSON & JOHNSON LENS OF DIFFERENT MODEL (DCB00), A MONOFOCAL IOL WAS IMPLANTED AS A REPLACEMENT. UNKNOWN IF OTHER INTERVENTIONS PERFORMED OR NOT. THE PATIENT OUTCOME WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 18243476 ↗
• InjuryOct 30, 2023Adverse 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 THE LEFT EYE DUE TO THE PATIENT EXPERIENCING BLURRY VISION AND STARBURSTS THAT AFFECTED NIGHT TIME DRIVING. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIB00 15.5 DIOPTER). AN INCISION ENLARGEMENT WAS REQUIRED. NO SUTURES OR VITRECTOMY WAS REQUIRED AND THERE WAS NO PATIENT INJURY. AT ONE DAY POST-OPERATIVE, THE PATIENT REPORTED SEEING MUCH CLEARER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers

  MAUDE report 18036149 ↗
• InjuryJul 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE THE PATIENT EXPERIENCED BLURRY VISION FOR DISTANCE ALL ALONG, WITH OR WITHOUT THE USE OF SYSTANE LUBRICATING EYE DROPS TO ALLEVIATE ANY DRY EYE CONDITION. THERE MAY HAVE BEEN SOME IMPROVEMENT AFTER ALL THE ONE-MONTH EYE MEDICATIONS FROM THE CATARACT SURGERY WERE COMPLETE. THE DOCTOR INFORMED THE PATIENT THAT WITH MORE HEALING AND ADJUSTMENT, THE CLARITY OF THE VISION MAY IMPROVE. THE PATIENT HAS A THREE MONTH CHECK UP ON (B)(6) 2022 TO SEE IF DISTANT VISION IMPROVED. THE PATIENT REPORTED VISUAL ACUITY IS CLOSER TO 20/20 BASED ON EYE CHART WITH SOME BLINKING AND FOCUSING HARD. PRESENTLY, THE PATIENT IS UNABLE TO READ ROAD SIGNS, WHICH ARE BLURRY AS WELL AS WHEN LOOKING AT TREES, THE LEAVES ARE NOT CLEAR. THE PATIENT IS EXPERIENCING GLARE OF HEADLIGHTS (MORE DIFFUSE) IN THE NIGHT AND HALOS. THE PATIENT CAN DRIVE; HOWEVER, THE PATIENT AVOIDS NIGHT DRIVING. THERE WERE NO COMPLICATIONS FROM EYE SURGERY AND THE EYE IS HEALING WELL. THROUGH FOLLOW-UP WITH THE PATIENT, IT WAS LEARNED THAT THE PATIENT IS ONLY ABLE TO DRIVE DURING THE DAY OR NIGHT RELYING ON THE RIGHT EYE FOR DISTANCE VISION. THE DI

  Patient problems: Blurred Vision; Dry Eye(s); Halo; Inflammation; Visual Disturbances

  MAUDE report 15099164 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A JOHNSON & JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO EXPERIENCING DIFFICULTY WITH THEIR VISION. THEIR LEFT EYE WAS BLURRY ESPECIALLY WHEN READING OR DRIVING. THE PATIENT HAD DIFFICULTY DRIVING FOR AN EXTENDED PERIOD OF TIME (MORE THAN AN HOUR). ALSO, THE LEFT EYE VISION WAS SLIGHTLY DARKER THAN THE RIGHT EYE AND THE DOCTOR¿S DIAGNOSIS IS MECHANICAL OBSTRUCTION OF INTRAOCULAR LENS. THE CUSTOMER DOES NOT KNOW IF THERE WAS A ROTATION OR CALCULATION ISSUE. REPORTEDLY, THERE WAS NO CAPSULE TEAR, VITRECTOMY OR SUTURES REQUIRED. NO MEDICATIONS OUTSIDE THE REGULAR STANDARD OF CARE WERE REQUIRED. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER JNJ IOL, MODEL ZLU150, 15.5 DIOPTER. IT WAS REPORTED THAT AFTER THE EXPLANT THE PATIENT IS DOING WELL. HOWEVER, THEY COMPLAINED ABOUT BLURRINESS IN THEIR LEFT EYE BUT STATES IT HAS BEEN IMPROVING. PATIENT DENIES DISCOMFORT OR PAIN. IT WAS INDICATED THAT DURING THE PRE OP VISIT, THE PATIENT'S VISUAL ACUITY IN THE LEFT EYE WAS 20/40 AND THEIR VISUAL ACUITY AT ONE-DAY POST OP WAS 20/30 FOR THAT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 14049019 ↗