TECNIS IOL ZKU150 (REF ZKU150U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474687028), received between Aug 6, 2021 and Feb 15, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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.

• InjuryFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO DYSPHOTOPSIA. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, DIFFERENT MODEL (DIU150 19.5 DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY. THE PATIENT IS DOING GREAT POST-OPERATIVELY.

  Patient problems: Visual Disturbances

  MAUDE report 16380452 ↗
• MalfunctionJun 9, 2022Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF THE INTRAOCULAR LENS (IOL) KINKED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14651257 ↗
• InjuryDec 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED BLURRY VISION AND THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE. ANOTHER JOHNSON & JOHNSON IOL (DIFFERENT MODEL ZCU150 AND DIFFERENT DIOPTER OF 20.5) WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO PATIENT INJURY, AND NO ADDITIONAL MEDICAL OR SURGICAL PROCEDURES WERE PERFORMED. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision

  MAUDE report 12977828 ↗
• InjuryAug 6, 2021Adverse 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 FROM PATIENT'S LEFT EYE DUE TO BLURRY VISION. ANOTHER JOHNSON AND JOHNSON LENS OF DIFFERENT MODEL BUT SAME DIOPTER WAS IMPLANTED. NO OTHER MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE PATIENT WAS REPORTEDLY DOING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 12291895 ↗