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TECNIS IOL ZXT300 (REF ZXT300U240)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 24.0D CYL3.00 · Class 3 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606463), received between Apr 27, 2017 and Sep 6, 2019 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • No Code Available3
  • Visual Disturbances3
  • Dry Eye(s)1
  • Halo1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE PATIENT HAD THE IOL IMPLANTED IN PATIENT¿S BOTH OPERATIVE EYES. REPORTEDLY RIGHT EYE HAD IMPLANT ON (B)(6) 2018 AND THE LEFT EYE HAD IMPLANT ON (B)(6) 2018. 1 MONTH LATER PATIENT WAS COMPLAINING HALOS, STARBURST AND NIGHT DRIVING. DOCTOR HAS DISCUSSED POSSIBLE EYE DROPS IN THE FUTURE PRIOR TO NIGHT DRIVING TO HELP CONSTRICT PUPILS AND HAS BEEN MONITORING THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT AT 6 MONTHS VISIT PATIENT WAS EXTREMELY BOTHERED STARBURSTS AND GLARE WHICH IS AFFECTING NIGHT DRIVING AND DAILY ACTIVITIES. THE LENS IN BOTH THE EYES REMAINS IMPLANTED WITH NO INTERVENTION PLANNED. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S RIGHT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Dry Eye(s); Halo; No Code Available; Visual Disturbances

    MAUDE report 8968316 ↗
  • InjuryMay 26, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZXT300 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT DUE TO VISUAL DISTURBANCE. THE LENS WAS REPLACED WITH A ZCT300 24.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available; Visual Disturbances

    MAUDE report 6596214 ↗
  • InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A PHYSICIAN REPORTED HAVING A PATIENT WHO IS SIGNIFICANTLY BOTHERED BY GLARE POST IMPLANT OF A ZXT300 24.0 DIOPTER INTRAOCULAR LENS. THE PATIENT WILL ALMOST DEFINITELY BE GETTING AN INTRAOCULAR LENS (IOL) EXCHANGE. THE PHYSICIAN NOTED SHE WOULD LIKE TO EXCHANGE THE LENS FOR A MONOFOCAL TORIC LENS.

    Patient problems: No Code Available; Visual Disturbances

    MAUDE report 6525042 ↗

Other Extended depth of focus intraocular lens devices

All Extended depth of focus intraocular lens devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.