TECNIS IOL DFW225 (REF DFW225U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474751828), received between Jan 6, 2022 and Aug 8, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 8, 2024Adverse 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 BECAUSE DURING IMPLANTATION THE CRYSTALLINE LENS CAPSULE BROKE. THE ISSUE WAS OBSERVED DURING INSERTION. THERE WAS PATIENT INJURY. THERE WAS NO ERROR THAT LED TO THE EVENT. THE INCISION WAS ENLARGED, A VITRECTOMY WAS REQUIRED, AND SUTURES WERE USED. DIAMOX WAS PRESCRIBED. ANOTHER JOHNSON AND JOHNSON IOL (AR40E 18.5 DIOPTER) WAS IMPLANTED AS REPLACEMENT. THE PATIENT DID NOT HAVE ANY PRE-EXISTING CONDITION RELATED TO THE EYE. THERE WAS NO SIGNIFICANT INTERFERENCE WITH DAILY ACTIVITIES. POST-OPERATIVE DAY ONE ON JUL 17, 2024, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS 30. THE PATIENT WAS GIVEN TIMOLOL AND DIAMOX. VISION WAS 20/400. THE PATIENT WILL RETURN FOR FOLLOW-UP RE-CHECK ON JUL 19, 2024. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear; Intraocular Pressure Increased

  MAUDE report 19945163 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS FULLY INSERTED THEN REMOVED FROM THE PATIENT'S RIGHT EYE DURING THE SAME PROCEDURE DUE TO BAG INTEGRITY "BAG NO LONGER ABLE TO SUPPORT LENS". THE REPLACEMENT IOL USED WAS A SULCUS LENS, 1.0 DIOPTER LOWER POWER SIZE THAN THE ORIGINAL IOL (AR40E +17.5). HOWEVER, IT WAS NOTED BY THE CUSTOMER THAT THERE WAS NO PRODUCT QUALITY ISSUE, NO USE ERROR. IT WAS ALSO NOTED THAT PATIENT WAS DOING WELL THE FOLLOWING DAY, NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. OPHTHALMIC VISCOSURGICAL DEVICES (OVD) WAS USED, AND IT WAS ALLOWED TO ACCLIMATIZE IN OPERATING ROOM TEMPERATURE AS WELL AS THE BALANCED SALT SOLUTION (BSS) USED. THERE WAS NO DELAY IN SURGERY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 18577100 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE AS PATIENT HAD DIFFICULTY DRIVING AT NIGHT DUE TO HALOS. ANOTHER JOHNSON & JOHNSON LENS OF SAME DIOPTER, BUT DIFFERENT MODEL (DIU225) WAS USED AS REPLACEMENT. THE LENS WILL NOT BE RETURNED AS IT WAS DISCARDED AFTER EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 18165277 ↗
• InjuryMar 24, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE AS THE LENS WAS DISLODGED IN THE EYE. A COMPETITOR LENS OF 17.5 DIOPTER WAS USED AS THE REPLACEMENT. IN ADDITION, A VITRECTOMY WAS PERFORMED AND SUTURES WERE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13896398 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO HALOS AND GLARE. THE INCISION WAS ENLARGED AND ANOTHER JOHNSON & JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER (SN_(B)(4)) WAS USED AS THE REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 13185689 ↗