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TECNIS IOL ZXT300 (REF ZXT300U230)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 23.0D CYL3.00 · Class 3 · Implant

All models of TECNIS IOL (1344)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606449), received between Dec 13, 2017 and Oct 31, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

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

Device problems

  • Break2
  • Unintended Movement2
  • Adverse Event Without Identified Device or Use Problem1
  • Scratched Material1

Patient problems

  • No Code Available3
  • Blurred Vision1
  • Halo1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 31, 2020Break; Break

    THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGE. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10767123 ↗
  • InjuryOct 16, 2019Break; Scratched Material; Unintended Movement; Break; Scratched Material; Unintended Movement

    IT WAS REPORTED THAT A MODEL ZXT300 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO THE PATIENT EXPERIENCING BLURRY VISION ONE DAY POST-IMPLANT. ADDITIONAL INFORMATION RECEIVED STATED SLIGHTLY WRONG POWER AND ORIENTATION ISSUE (IOL ROTATED), AND THE LENS HAD A SCRATCH ON IT. WHEN THE PATIENT PRESENTED ON (B)(6) 2019 THE AXIS OF THE IOL WAS AT 75 DEGREES. THE REPLACEMENT LENS IS A DIFFERENT MODEL (ZXT150), BUT SAME DIOPTER AND WAS PLACED IN THE PATIENT¿S EYE AT 14 DEGREES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED. PATIENT OUTCOME IS REPORTED TO BE EXCELLENT. NO OTHER INFORMATION WAS PROVIDED.

    Patient problems: Blurred Vision; No Code Available

    MAUDE report 9200316 ↗
  • InjuryNov 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT PATIENT HAD TECNIS SYMFONY TORIC (MODEL ZXT300, +23.0 DIOPTER) IMPLANTED IN HER LEFT EYE (B)(6) 2017. REPORTEDLY, THE PATIENT COMPLAINED OF HALOS AND GLARE WHICH NEVER WENT AWAY. A SECONDARY SURGERY IS SCHEDULED FOR (B)(6) 2018, TO EXPLANT THE LENS AND REPLACE IT WITH A MODEL ZCT LENS. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Halo; No Code Available

    MAUDE report 8062504 ↗
  • InjuryDec 13, 2017Unintended Movement; Unintended Movement

    IT WAS REPORTED THAT ZXT300 23.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT RIGHT EYE ON (B)(6) 2017, DUE TO 37 DEGREE ROTATION THAT WAS NOTICED AT THE ONE DAY POST OP VISIT. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR CAPSULE TEAR. THE LENS WAS REPLACED WITH ZXROO 22.0 DIOPTER IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING EXCELLENT POST-OPERATIVELY. IT WAS ALSO REPORTED THAT THE PATIENT HAD POOR K READINGS PRE-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 7115191 ↗

Other Extended depth of focus intraocular lens devices

All Extended depth of focus intraocular lens devices →

Sources and updates

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