TECNIS IOL ZXT300 (REF ZXT300U285)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474606555), received between Nov 16, 2016 and Dec 28, 2018 — 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 16, 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.

• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300 +28.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING HALOS. PATIENT ENDED UP HAVING MONOFOCAL TORIC. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT PATIENT WAS EXPERIENCING HIGH HYPEROPIA, ASTIGMATISM, NARROW ANGLE, SIGNIFICANT HALOES AND GLARE WITH LIGHTS. PRE OP REFRACTION OD:+6.0-2.75X35. PRIMARY SURGERY WAS UNCOMPLICATED. THERE WAS NO PATIENT INJURY. PATIENT WAS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8203980 ↗
• InjuryNov 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 28.5 DIOPTER INTAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN INCORRECT CORRECTION OF ASTIGMATISM. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES AND NO PATIENT INJURY POST-OP. THE LENS WAS REPLACED WITH A ZXT225 28.0 DIOPTER LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6105076 ↗