TECNIS IOL DXW225 (REF DXW225U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474764163), received between Dec 15, 2023 and Feb 24, 2025 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE (OS) IN A SECONDARY SURGICAL PROCEDURE DUE TO MULTIFOCAL INTOLERANCE. THE PATIENT COMPLAINED OF SYMPTOMS OF CLOUDY VISION AND REPORTEDLY WAS UNABLE TO PERFORM ONE OR MORE DAILY ACTIVITIES POST CATARACT SURGERY. A MONOFOCAL LENS OF HIGHER DIOPTER (MODEL DCB00, 21.0D) WAS USED AS A REPLACEMENT. DURING IOL EXCHANGE, OLD INCISION OPENED NEXT TO CURRENT AND MADE ONE (1) BIG INCISION REQUIRING TWO (2) TEMP SUTURES AT INCISION. IT WAS CLARIFIED THAT THE SUTURES WERE NOT DUE TO AN INJURY, THE OLD INCISION OPENED UP TO A FOUR (4) MM INCISION, WHICH REQUIRED TWO (2) SUTURES. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT'S POST-OP STATUS WAS REPORTED AS VISUAL ACUITY (VA) IN OS BLURRY, FOREIGN BODY (FB) SENSATION. IT WAS NOTED THAT THE EXPLANTED DEVICE WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE FIRST LENS MENTIONED (ORIGINAL LENS THAT WAS EXPLANTED). NO REPORT WILL BE FILED AGAINST THE REPLACEMENT LENS AS THE EVENT DOES NOT MEET REPORTABILITY CRITERIA.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 21451108 ↗
• InjuryDec 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC II INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO BLURRY VISION. THIS WAS REPLACED WITH A TECNIS EYHANCE TORIC II IOL, MODEL DIU225, BUT SAME DIOPTER SIZE AS THE ORIGINAL IOL. NO ADDITIONAL SURGICAL INTERVENTIONS WERE INDICATED AND NO PATIENT INJURY REPORTED. IT WAS NOTED THAT AT. 1 DAY POST OP VISUAL ACUITY (VA) 20/30-2. 1 WEEK POST OP VA 20/40-1. 1 MONTH POST OP VA 20/30-2, RIGHT EYE (OD). MANIFEST REFRACTION (MRX) PLANO -1.00 115 20/20- 1 MONTH POST OP LEFT EYE (OS) - OD VA 20/30-2 OS MRX +0.25 -1.00 115 20/20-1. PATIENT STATES THAT SHE IS UNHAPPY WITH STARBURSTS AROUND LIGHTS OD MRX PLAMO -0.75 110 20/25+2 POSTERIOR CAPSULE OPACIFICATION (PCO) CHECK FOUND TO BE MINIMAL. PATIENT STATES THAT HER STARBURSTS AND HALOS HAVE BEEN PRESENT DAILY. VA 20/40 OD MRX +0.25 -0.25 116 20/30 PATIENT STILL STATES THAT STARBURST AND HALOS ARE PRESENT. UNABLE TO NEUROADAPT AFTER > 6 MONTHS. PLAN FOR IOL EXCHANGE. VA 20/25-3 OD MRX PLANO PLANO 20/25-3. IT WAS NOTED THAT THE PATIENT WAS SEEN FOR 1 DAY POST EXPLANT ON 11/21/23 VA 20/30-2. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Flashers; Halo

  MAUDE report 18341522 ↗