TECNIS IOL DFW225 (REF DFW225U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751941), received between May 19, 2022 and Mar 13, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE SURGEON PLANS TO EXPLANT THE FULLY IMPLANTED INTRAOCULAR LENS (IOL) DUE TO GLARE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS EXPLANTED IN A SECONDARY PROCEDURE. ANOTHER JOHNSON AND JOHNSON LENS WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL, DIU225, DIFFERENT DIOPTER, +25.0). THE DEVICE WAS DISCARDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 16530814 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE DFW225 INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO THE PATIENT'S OCULAR DEXTER (RIGHT EYE) IT WAS REPORTED THE CAPSULE TORE/COLLAPSED. THE IOL WAS REMOVED AND THE SAME PROCEDURE WAS COMPLETED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, DIOPTER SIZE UNKNOWN. OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE AND PATIENT STATUS IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Capsular Bag Tear

  MAUDE report 16415115 ↗
• InjuryMay 19, 2022Unstable; Unstable

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED THE PATIENT EXPERIENCED SIGNIFICANT POSITIVE DYSPHOTOPSIA. LOTS OF DISTORTED VISION OR BRIGHT LIGHTS EVEN IN DAYTIME CAUSING WEIRD REFLECTIONS IN THEIR VISION. THE PATIENT'S RANGE OF VISION IS 20/30 UNCORRECTED DISTANCE VISUAL ACUITY (UCVDA), 20/10 UNCORRECTED INTERMEDIATE VISUAL ACUITY (UCIVA), 2020 UNCORRECTED BINOCULAR VISUAL ACUITY (UCNVA) WITH MRX +0.50 - 0.75 X 037 AND 20/20 CORRECTED DISTANCE VISUAL ACUITY (CDVA). THE PATIENT ALSO FEELS PERIPHERAL VISION IS SOMEWHAT RESTRICTED. THE DOCTOR IS AWAITING A TIME TO DILATE PATIENT AND VERIFY PROPER TORIC ALIGNMENT AND IS GIVING THE PATIENT TIME TO NEUROADAPT. THE DOCTOR HAS ALSO GIVEN PATIENT A SAMPLE OF A MIOTIC DROP TO SEE IF IT HELPS WITH THE DYSPHOTOPSIA. ADDITIONALLY, IT WAS LEARNED THAT THE PATIENT IS HAVING DIFFICULTY DRIVING. THE DOCTOR REPORTED THAT THE LENS ROTATED SIX DEGREES. THE IOL REMAINS IMPLANTED IN THE LEFT EYE, BUT INDICATED THAT THE DOCTOR WILL PROBABLY PLAN AN IOL EXCHANGE. THROUGH ADDITIONAL FOLLOW-UP, IT WAS LEARNED THAT THE IOL WAS EXCHANGED IN THE LEFT EYE. ANOTHER JOHNSON & JOHNSON IOL WAS IMPLANTED AS A REPLACEMENT (DFW150 25.0 DIOPTER).

  Patient problems: Flashers

  MAUDE report 14440567 ↗