TECNIS IOL ZXT300 (REF ZXT300U105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606197), received between Jul 26, 2018 and Sep 20, 2021 — classified as 3 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 16, 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.

• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE PATIENT VISITED THEIR DOCTOR AT 6-MONTH POST-OP. THEIR VISUAL ACUITY WAS REPORTED AS FOLLOWS, UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) FOR THE RIGHT EYE (OD) WAS 20/30 AND FOR THE LEFT EYE (OS) 20/25. THEIR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/20 FOR BOTH EYES (OU). THE PATIENT REPORTED BEING VERY BOTHERED BY HALOS, VERY BOTHERED BY STARBURSTS, MODERATELY BOTHERED WITH SENSITIVITY TO LIGHT, VERY BOTHERED BY GLARE WHILE WORKING ON A COMPUTER AND READING BOOKS. THERE ARE NO PLANS FOR SURGICAL INTERVENTION AND THE PATIENT IS NOT ON ANY MEDICATION OUTSIDE OF THE REGULAR CURRICULUM. HOWEVER, THE SYMPTOMS ARE REPORTED TO BE DEBILITATING TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE RIGHT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR THE LEFT EYE.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 12502856 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING REFRACTIVE ERROR POST OP AND WAS NOT HAPPY. SYMPTOMS WERE FIRST NOTED AT TWO MONTHS POST IMPLANT. ANOTHER LENS, MODEL ZXT150 AND SMALLER DIOPTER OF +10.0 WAS USED AS REPLACEMENT LENS FOR THE PATIENT. INCISION ENLARGEMENT WAS REQUIRED DURING THE EXPLANT PROCEDURE. PATIENT HAD IMPROVED OUTCOME. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10136521 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300 +10.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF A REFRACTIVE ERROR AND PATIENT EXPERIENCING MYOPIA. LENS MODEL ZXT225 +29.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7721798 ↗