TECNIS IOL DFW150 (REF DFW150U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474751248), received between Feb 28, 2022 and May 22, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Scratched Material” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 22, 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 EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO HALOS. INCISION WAS ENLARGED TO REMOVE THE IOL. REPLACEMENT IOL ZCB00, 19.0 DIOPTER SIZE. VISUAL ACUITY PRE-OP WAS 20/40, VISUAL ACUITY POST-OP WAS 20/20. THERE WAS NO DELAY REPORTED AND NO VITRECTOMY OR SUTURES REQUIRED. PATIENT DOING WELL AFTER IOL EXCHANGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 16981571 ↗
• InjuryNov 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING BLURRY VISION AND GLARE AROUND POINT SOURCES OF LIGHT IN THEIR LEFT EYE (OS) RESULTING IN THE NEED TO EXPLANT THE INTRAOCULAR LENS (IOL). THE PATIENT'S PRE-OPERATION BEST CORRECTED VISUAL ACUITY (BCVA) IS 20/50. THE PATIENT'S POST-OPERATION UNCORRECTED VISUAL ACUITY (UCVA) IS 20/50 AND BCVA 20/40. THE TARGETED POST-OPERATION REFRACTION WAS 20/20 BOTH EYE. NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES WERE REQUIRED. THE REPLACEMENT IOL WAS A DIFFERENT JOHNSON AND JOHNSON LENS (MODEL DIU150,18.5 DIOPTER). THERE WAS NO REPORTED PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 15741063 ↗
• InjuryOct 29, 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 PATIENT'S RIGHT EYE DUE TO HALOS WHICH THEY CLAIM SIGNIFICANTLY INTERFERE WITH PATIENT'S DAILY ACTIVITIES. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. THE REPLACEMENT LENS IS A NON JOHNSON AND JOHNSON IOL. PATIENT FINE POST-EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 15696239 ↗
• InjuryJul 20, 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 PATIENT'S RIGHT EYE DUE TO THE PATIENT IS NOT HAPPY WITH THE OUTCOME AND IS UNHAPPY WITH QUALITY OF VISION. ANOTHER LENS WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 15070981 ↗
• MalfunctionApr 1, 2022Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) WAS FULLY INSERTED AND REMOVED FROM PATIENT'S RIGHT EYE AS THE LENS WAS SCRATCHED. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THE ORIGINAL LENS WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13983146 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE, THE PATIENT COMPLAINED OF NIGHTTIME HALOS, GLARE, SEEING INDIVIDUAL RINGS, AND COLORS ARE OFF AND NOT SHARP. THE PATIENT CANNOT READ FOR ANY EXTENDED PERIOD OF TIME, HOWEVER NEAR VISION IS FINE FOR SHORT PERIODS. INTERMEDIATE AND DISTANCE VISION ARE WORSE THAN PRIOR TO SURGERY. THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH THE PATIENT'S DAILY ACTIVITIES AND WERE DEBILITATING. THE IOL WAS EXPLANTED. ANOTHER JOHNSON AND JOHNSON IOL (DIFFERENT MODEL, DIU150, SAME DIOPTER) WAS IMPLANTED AS REPLACEMENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED AND NO PATIENT INJURY. THE PATIENT WAS HAPPY AT ONE DAY POST-OPERATIVE OF THE IOL EXCHANGE. THE PATIENT'S PRE-OPERATIVE BEST CORRECTED AND UNCORRECTED VISUAL ACUITY ON (B)(6) 2021 WAS 20/25. THE PATIENT'S POST-OPERATIVE UNCORRECTED VISUAL ACUITY WAS 20/30 AND POST-OPERATIVE BEST CORRECTED VISUAL ACUITY WAS 20/20 ON (B)(6) 2022. THERE ARE NO ADDITIONAL INTERVENTIONS PLANNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort; Halo; Visual Disturbances

  MAUDE report 13625329 ↗