TECNIS IOL ZXT225 (REF ZXT225U325)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606043), received between Jun 28, 2017 and Feb 4, 2020 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2020Break; Break

  IT WAS INITIALLY REPORTED THAT INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S OPERATIVE IN SAME SURGICAL PROCEDURE DUE TO SPLIT IN LENS. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT DURING THE EXPLANT PROCEDURE THE FIRST REPLACEMENT LENS USED WAS REMOVED AND REPLACED IN SAME SURGICAL PROCEDURE AS IT SPLIT IN THE EYE. ANOTHER LENS WITH SAME MODEL AND DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. INCISION WAS ENLARGED DURING THIS PROCEDURE. PATIENT HAD NO COMPLICATIONS. THIS REPORT WILL CAPTURE INFORMATION FOR FIRST REPLACEMENT LENS THAT HAD SPLIT IN THE EYE DURING EXPLANT PROCEDURE. ANOTHER REPORT IS SUBMITTED FOR THE LENS THAT WAS EXPLANTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9669100 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WITH MODEL ZXT225 +33.5 DIOPTER WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE BECAUSE OF PATIENT UNHAPPY WITH 20/40 UNCORRECTED VISUAL ACUITY. DURING THE EXPLANT PROCEDURE ONE LENS WAS REMOVED AND REPLACED AS THE LENS GOT TORN DURING THE PROCEDURE. REPORTEDLY LENS WITH SAME MODEL AND LOWER DIOPTER OF +32.5 WAS USED AS REPLACEMENT FOR THE PATIENT. THIS REPORT WILL CAPTURE INFORMATION FOR THE EXPLANTED LENS. ANOTHER REPORT IS BEING SUBMITTED UNDER VMSR REPORTING WILL CAPTURE THE EVENT FOR THE TORN LENS DURING THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9542099 ↗
• InjuryFeb 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 32.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED IN THE RIGHT EYE (OD) OF A FEMALE PATIENT DUE TO VISUAL DISTURBANCE. THE OUTCOME SIGNIFICANTLY INTERFERED WITH PATIENT''S DAILY LIFE ACTIVITIES PRIOR TO THE LENS EXCHANGE. A REPLACEMENT LENS OF THE SAME MODEL WITH DIFFERENT DIOPTER (31.0) WAS USED. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. THE DEVICE WAS ALREADY DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7265467 ↗
• MalfunctionJun 28, 2017Crack; Crack

  IT WAS REPORTED THAT THERE WAS A CRACK ON THE INTRAOCULAR LENS (IOL) THAT WAS NOTICED DURING INSERTION OF THE IOL INTO THE PATIENT'S EYE. THERE WAS PATIENT CONTACT WITH THE IOL AND THE CARTRIDGE TIP. THE IOL WAS NOT FULLY INSERTED. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SERIOUS PATIENT INJURY. NO SUTURES WERE REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A BACKUP IOL WITH SAME MODEL AND DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6675301 ↗