TECNIS IOL ZXT300 (REF ZXT300U130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606241), received between Apr 11, 2017 and Mar 3, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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

• InjuryMar 3, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A ZXT300 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE AS IT APPEARED THAT THE LENS WAS OUT OF SPEC. PATIENT EXPERIENCED VERY BLURRY VISION, HEADACHES, AND EYE FIGHTING ISSUES, PATIENT OUTCOME NOTED AS POOR. INITIALLY DOCTOR HAD AIM AND PLAN CHOSEN WAS PLANO USING TORIC LENS, EXTENDED DEPTH OF FOCUS IOL TO GIVE THE PATIENT SPECTACLE INDEPENDENCE. POST OPERATIVE OUTCOMES AND DIAGNOSTICS REFLECTED THAT POWER OF LENS IS NOT REFLECTIVE OF THE LENS THAT WAS IMPLANTED. THE EVENT WAS OBSERVED DURING POST OPERATIVE EXAMINATION. THERE WAS A DELAY OF TWO WEEKS TO THE EXCHANGE. DOCTOR REMOVED THIS IOL AND IMPLANTED THE PATIENT WITH THE EXACT SAME POWER AND MODEL, AND PATIENT'S VISION IMPROVED IMMENSELY. PATIENT IS HAPPY NOW. AT EXCHANGE NO MEDICAL/SURGICAL INTERVENTIONS SUCH AS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE PERFORMED. VISUAL ACUITY PRE-OPERATIVE :UNCORRECTED: COUNT FINGERS, CORRECTED: 20/25. VISUAL ACUITY POST-OPERATIVE: UNCORRECTED: 20/400, CORRECTED: 20/25. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Eye Pain; Headache

  MAUDE report 11408425 ↗
• InjuryOct 1, 2020Unintended Movement; Unintended Movement

  A DOCTOR REPORTED OF A PATIENT WITH BILATERAL ROTATION. REPORTEDLY THE PATIENT HAD HIGH MYOPIA AND REQUIRED CAPSULAR TENSION RINGS (CTRS) AT THE TIME OF SURGERY TO STABILIZE THE CAPSULAR BAG. THE PATIENT IS COMPLAINING OF POOR VISION AND GLARE. THE DOCTOR ROTATED THE LENS TO ITS IDEAL AXIS IN A SECOND PROCEDURE. SUTURES WERE USED DURING THE PROCEDURE AND THE LENS REMAINS IMPLANTED. NO HARM OR INJURY POST-OP WAS NOTED IN THE RECORD. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT IS FOR THE PATIENT'S LEFT EYE (OS). A SEPARATE REPORT WILL BE FILED FOR THE PATIENT'S RIGHT EYE (OD).

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 10618112 ↗
• InjuryApr 11, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT300 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT REQUIRING A DIFFERENT LENS POWER. THE LENS WAS REPLACED WITH A 14.5 DIOPTER LENS AND PATIENT IS DOING WELL. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6483572 ↗