TECNIS IOL DFW225 (REF DFW225U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474751804), received between Nov 25, 2023 and May 17, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED THAT HE INTENDED TO IMPLANT A SYMFONY INTRAOCULAR LENS (IOL) BUT IMPLANTED A SYNERGY LENS. IT WAS CONFIRMED THAT THERE WAS NO MISTAKE OR ERROR ON THE LABEL OF THE DEVICE, THAT IT WAS ON DOCTOR'S PAPERWORK. THE DOCTOR WAS NOT AND IS NOT CONCERNED ABOUT THE SYNERGY LENS BEING PUT IN BECAUSE HE FREQUENTLY DOES MIX AND MATCH LENSES. IT WAS INDICATED THAT IN THE EYE THAT HAS THE SYNERGY LENS, THE PATIENT IS .5 DIOPTER HYPEROPTIC. THE PATIENT DID NOT HAVE DEBILITATING CONDITION. THE PATIENT HAS VERY MILD DRUSEN AND STATES THAT NEAR VISION THAT EYE IS BLURRY. THE PATIENT IS FINE, JUST NOT HAPPY WITH THE NEAR/OVERALL VISION, HAS DRY EYE & TEARS ARE POOLING IN THAT EYE. THE PATIENT PUT ON ARTIFICIAL TEARS BUT DID NOT MAKE MUCH OF A DIFFERENCE. NO OUTSIDE OF STANDARD CARE MEDICATION WAS PRESCRIBED TO THE PATIENT. IT WAS NOTED THAT THE CAPSULE APPEARS TO BE CLOUDY. THE PATIENT IS 20/20 BUT AGAIN NOT HAPPY WITH NEAR VISION IN THE EYE WHICH HAS THE SYNERGY LENS. THE DOCTOR WAS CONSIDERING AN EXPLANT OR YTTRIUM-ALUMINUM-GARNET (YAG) ON THAT EYE. IN THE SECOND EYE THE DOCTOR IMPLANTED A SYMFONY OPTIBLUE LENS AND THE PATIENT IS VERY HAPPY WITH THE VISION IN THAT EYE. ADDITIONAL I

  Patient problems: Blurred Vision; Dry Eye(s); Excessive Tear Production; Posterior Capsule Opacification; Visual Impairment

  MAUDE report 19346851 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NON PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANT FROM PATIENT'S EYE AS THE PATIENT WAS UNHAPPY. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 19055328 ↗
• MalfunctionNov 25, 2023Break; Break

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (IOL) WAS DEFECTIVE. THERE WAS PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18207665 ↗