TECNIS IOL ZXT225 (REF ZXT225U265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474605923), received between Feb 21, 2018 and Jan 13, 2026 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S RIGHT EYE. DURING A POST-OPERATIVE VISIT, IT WAS NOTICED THAT THE LENS SUBLUXATED AND THE PATIENT¿S VISION SUDDENLY WENT BLURRY WHILE WATCHING TELEVISION. THE PATIENT¿S PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (BSCVA) WAS 20/70 AND BSCVA POST-OPERATIVE IS 20/LPO (LOW POWER OBJECTIVE). THE IOL WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON AND JOHNSON LENS OF +29.0 DIOPTER. THERE WAS A 45-MINUTE DELAY IN PROCEDURE. NO INCISION ENLARGEMENT, SUTURES, OR VITRECTOMY REPORTED. NO MEDICAL ATTENTION OR MEDICATION OUTSIDE OF THE STANDARD OF CARE WAS REQUIRED. THE PATIENT HAS FULLY RECOVERED POST EXPLANT. THE CUSTOMER INDICATED THE DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 24050289 ↗
• InjuryApr 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE BECAUSE THEY WERE UNHAPPY. THE REPLACEMENT IOL WAS A DIFFERENT J&J MODEL ZLU150 26.5 DIOPTER. THE EXPLANTED IOL WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 14152682 ↗
• InjuryJun 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) EXCHANGE WAS PERFORMED. ADDITIONAL INFORMATION OBTAINED REVEALED THE IOL WAS EXCHANGED FROM THE RIGHT EYE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NO RESPONSE HAS BEEN RECEIVED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8677456 ↗
• InjuryFeb 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT WAS NOT HAPPY. REPORTEDLY, THERE WAS NOTHING WRONG WITH THE LENS JUST AN EXCHANGE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZCB00 24.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING GREAT POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7287708 ↗