TECNIS IOL DFW225 (REF DFW225U235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751927), received between Dec 10, 2022 and Mar 9, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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.

• MalfunctionMar 9, 2023Break; Break

  IT WAS REPORTED THAT THE PRELOADED INTRAOCULAR LENS (IOL) HAD A DEFECT NOTED UPON INSERTION. THE LENS WAS CUT OUT AND REMOVED. IT IS UNKNOWN IF ANOTHER LENS WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16519386 ↗
• InjuryMar 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BLURRY VISION, HENCE INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES DONE. IOL WAS REPLACED WITH A DIFFERENT MODEL LENS (DIU225) BUT SAME DIOPTER POWER SIZE. NO PATIENT POST-OP INJURY REPORTED. THE PATIENT CONTINUES TO NOTICE BLURRY VISION CAUSING DIFFICULTY DRIVING AND WOULD LIKE TO PROCEED WITH IOL EXCHANGE IN THE FELLOW EYE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 16483317 ↗
• InjuryDec 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DFW225 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). DOCTOR REPORTS PATIENT HAS INTRACTABLE POSITIVE PHOTOPSIA. OVER THE LAST 5-6 MONTHS THE DOCTOR HAS TRIED EVERYTHING TO TRY TO RESOLVE HER SYMPTOMS (INCLUDING SPECTACLE CORRECTION, PHOTOREFRACTIVE KERATECTOMY (PRK), AND PILOCARPINE EYEDROPS); BUT ULTIMATELY CONCLUDED THAT AN IOL EXCHANGE IS REQUIRED. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING PRK WAS NOT PERFORMED AND PILOCARPINE EYEDROPS WERE GIVEN (B)(6) 2022. DFW225 IOL EXPLANT IS PLANNED. NO OTHER INTERVENTIONS OR PATIENT INJURY REPORTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR THE PATIENT'S LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR THE PATIENT'S RIGHT EYE.

  Patient problems: Flashers

  MAUDE report 15955960 ↗