TECNIS IOL ZXT300 (REF ZXT300U095)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606173), received between Jun 6, 2017 and Jun 15, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

• InjuryJun 15, 2021Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD STARBURSTS IMMEDIATELY AFTER IMPLANT SURGERY OF AN INTRAOCULAR LENS (IOL). IT WAS ALSO INDICATED THAT A REPOSITIONING WAS DONE ON (B)(6) 2019 WITH NO IMPROVEMENT. THERE WAS A DELAY IN EXCHANGE DUE TO COVID. A JOHNSON AND JOHNSON TORIC LENS DIU375 9.5D WAS THE REPLACEMENT LENS USED. THE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT IMPROVED POST OP1 DAY WITH THE EXCHANGE FROM SYMFONY TORIC TO EYHANCE TORIC. VISUAL ACUITY (VA) PRE-OP 20/30. VA POST-OP 20/30. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 12004907 ↗
• MalfunctionSep 17, 2020Unintended Movement; Unintended Movement

  STUDY PATIENT REPORTED BEING BOTHERED BY THEIR POOR VISION IN LOW LIGHT AND READING REQUIRES BRIGHT LIGHT POST IMPLANT OF AN INTRAOCULAR LENS (IOL) IN EACH EYE. THEIR PREOP BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IS 20/25 BOTH EYES. POSTOP IS 20/20 BOTH EYES AT 1 MONTH VISIT. RIGHT EYE IOL AXIS PLACEMENT WAS 100 AT TIME OF SURGERY. THE SITE NOTED AN AXIS MISALIGNMENT ON (B)(6) 2020. RIGHT EYE IOL AXIS PLACEMENT 85 (POST-OP AXIS). NO PLANS FOR INTERVENTION AT THIS TIME. THRU FOLLOW-UP IT WAS CONFIRMED THAT THE MISALIGNMENT IS ONLY FOR THE RIGHT EYE. THE VISUAL SYMPTOMS ARE NOT SIGNIFICANTLY INTERFERING WITH ACTIVITIES OF DAILY LIFE AT THE PATIENT'S 1 MONTH FOLLOW-UP, THEY REPORTED SOMETIMES EXPERIENCING STARBURSTS AT NIGHT WHILE NOT WEARING GLASSES OR CONTACTS. THE STARBURSTS ARE SLIGHTLY BOTHERSOME. DURING THE DAY THEY OFTEN HAVE LIGHT SENSITIVITY WHICH IS MODERATELY BOTHERSOME. AT 1 MONTH THE PATIENT ALSO REPORTED POOR LOW LIGHT VISION OFTEN WHICH THEY FIND SLIGHTLY BOTHERSOME AS THEY CANNOT READ WITHOUT A BRIGHT LIGHT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected; Visual Disturbances

  MAUDE report 10544817 ↗
• InjuryJun 6, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) ROTATED AFTER IMPLANTATION IN THE PATIENT''S RIGHT EYE. THE LENS WAS REPOSITIONED IN A SECONDARY SURGICAL PROCEDURE ON (B)(6) 2017. REPORTEDLY, ON REPOSITIONING THE ORIGINAL AXIS WAS MAINTAINED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6616866 ↗