TECNIS IOL ZXT300 (REF ZXT300U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606371), received between May 24, 2017 and Mar 2, 2024 — classified as 4 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. How this data works · Data updated Oct 13, 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.

• InjuryMar 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE PATIENT REPORTED BEING UNHAPPY WITH THE PREMIUM IOL. SYMPTOMS LASTED APPROXIMATELY 3 MONTHS. FOLLOW-UP WAS PERFORMED BUT NO DETAILS REGARDING THE UNHAPPINESS WERE PROVIDED. CUSTOMER INDICATED THE DIRECTIONS FOR USE WERE FOLLOWED. THERE WAS NO INCISION ENLARGEMENT, SUTURES OR VITRECTOMY REQUIRED. MEDICATION OUTSIDE THE STANDARD OF CARE IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 18823354 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 INTRAOCULAR LENS WAS EXPLANTED DUE TO THE DOCTOR NOT CORRECTING THE ASTIGMATISM ENOUGH. HE IMPLANTED A ZXT375. THERE WAS NO INJURY, NO SUTURES, INCISION ENLARGEMENT OR VITRECTOMY. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11595734 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT300 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCE. THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT WAS SEEING HALOS. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A ZCT225 23.5 (HIGHER DIOPTER). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9879481 ↗
• InjuryMay 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT COULD NOT TOLERATE THE CORRECTION FOR THE ASTIGMATISM FROM THE TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS ZXT300 IN THE RIGHT EYE. THERE WERE NO POSTOP COMPLICATIONS BUT SHE DID NOT LIKE HER VISION POST OP. LENS WAS EXPLANTED. SURGEON EXTENDED THE ORIGINAL INCISION BY 2MM, REPLACED THE SYMFONY WITH A NON-AMO MONOFOCAL LENS AND USED A 10-0 SUTURE. NO VITRECTOMY WAS REQUIRED. THE INTRAOCULAR LENS WAS DISCARDED AT END OF SURGERY.

  Patient problems: No Code Available

  MAUDE report 6586827 ↗