TECNIS IOL DFW225 (REF DFW225U230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751910), received between Aug 18, 2022 and Mar 10, 2023 — classified as 3 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. How this data works · Data updated Oct 13, 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 10, 2023Adverse 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 PATIENT'S LEFT EYE AS THE PATIENT COULD NOT TOLERATE, GET USED TO HALOS IN BOTH EYES. THE ISSUE DID NOT SIGNIFICANTLY AFFECT PATIENT¿S DAILY ACTIVITIES. ANOTHER JOHNSON & JOHNSON LENS OF DIU MODEL WAS USED AS A REPLACEMENT (THE DIOPTER WAS NOT PROVIDED). NO FURTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED AND NO DELAY IN PROCEDURE REPORTED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo

  MAUDE report 16526598 ↗
• InjuryNov 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE BECAUSE THEY WERE EXPERIENCING INTOLERABLE HALOS AND GLARE. THERE WAS NO CAPSULE TEAR, UNPLANNED VITRECTOMY, SUTURES, OR MEDICATION OUTSIDE THE STANDARD OF CARE. THE SYMPTOMS WERE REPORTED TO BE DEBILITATING TO THE PATIENT BECAUSE THEY¿RE UNABLE TO DRIVE DURING THE DAY OR EVENING. THE REPLACEMENT IOL IS DIFFERENT THAN THE EXPLANTED LENS. THE REPLACEMENT IS MODEL DIU225 AND 23.50 DIOPTER. REPORTEDLY, THE PATIENT IS MUCH HAPPIER POST-OPERATION AS THEY NO LONGER HAVE EXPLODING LIGHTS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 15757023 ↗
• InjuryAug 18, 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 RIGHT EYE DUE TO INTOLERABLE DYSPHOTOPSIA AT NIGHT. PATIENT WAS GIVEN TIME TO HEAL AND TRY TO ADJUST. ANOTHER LENS OF DIFFERENT MODEL OF SAME CYLINDER POWER AND SLIGHTLY LESSER SPHERICAL DIOPTER WAS USED AS THE REPLACEMENT. THE PATIENT IS HEALING WELL AND THE INTOLERABLE DYSPHOTOPSIA AT NIGHT HAS RESOLVED IN THE RIGHT EYE. THE PATIENT MAY HAVE THE LENS IMPLANTED IN THE OTHER (LEFT) EYE EXPLANTED AS WELL, HOWEVER, IS WAITING TO SEE HOW THE PATIENT IS DOING WITH RIGHT EYE. THE ORIGINAL LENS ALREADY EXPLANTED FROM RIGHT EYE WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED. A SEPARATE REPORT WILL BE SUBMITTED CAPTURING THE LENS IN THE LEFT EYE, IF THE EVENT IS ASSESSED AS REPORTABLE UPON RECEIPT OF FURTHER INFORMATION.

  Patient problems: Visual Disturbances

  MAUDE report 15255316 ↗