Skip to content

TECNIS IOL ZXT300 (REF ZXT300U245)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 24.5D 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 05050474606470), received between Jul 25, 2018 and Dec 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
  • Blurred Vision1
  • Visual Disturbances1

Recent adverse event reports

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

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

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO GLARE AND POOR VISUAL ACUITY WITH CONSTANT FLASHES; SYMPTOM ONSET (B)(6) 2019. PATIENT DEVELOPED ISSUES WITH GLARE, VISION NOT FOCUSING SINCE THE CATARACT SURGERY. VISUAL DISTURBANCE ALSO REPORTED WITH NO OTHER MEDICAL OR SURGICAL INTERVENTIONS. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; No Code Available; Visual Disturbances

    MAUDE report 9430733 ↗
  • InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) ZXT300 WAS IMPLANTED ON (B)(6) 2017 INTO THE RIGHT EYE OF A MALE PATIENT. ON (B)(6) 2018 THE PATIENT REPORTED SEVERE STARBURSTS THAT PREVENTED HIM TO DRIVE AT NIGHT. THE IOL WAS EXPLANTED ON (B)(6) 2018 AND A NON-JOHNSON & JOHNSON LENS WAS IMPLANTED AS A REPLACEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY OCCURRED. REPORTEDLY, FOLLOWING THE IOL EXCHANGE, THE STARBURSTS WERE RESOLVED AND THE PATIENT WAS ABLE TO DRIVE AT NIGHT. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 8093803 ↗
  • InjuryJul 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZXT300 +24.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE AND WAS LATER EXPLANTED DUE TO A POWER MISS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7717546 ↗

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.