TECNIS IOL ZCU150 (REF ZCU150U135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474657663), received between Aug 14, 2023 and Feb 4, 2026 — classified as 2 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SINGLE PIECE NON-PRELOADED MONOFOCAL INTRAOCULAR LENS (IOL) WAS FULLY IMPLANTED IN A PATIENT'S RIGHT EYE. POST OP THE PATIENT EXPERIENCED UNEXPECTED REFRACTIVE OUTCOME THAT INCLUDED OVER-CORRECTION, LOSS OF TWO OR MORE LINES OF BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA), AND DIFFICULTIES WITH DEPTH PERCEPTION, WHICH IMPACTED DAILY ACTIVITIES SUCH AS DRIVING AND WALKING AND REQUIRED IOL EXPLANT. THE ACCOUNT REPORTED PATIENT¿S PRE-EXISTING CONDITIONS MAY HAVE AFFECTED THE CALCULATION (REFER TO B7). THE EXPLANT PROCEDURE WAS SUCCESSFUL AND THE IOL WAS REPLACED WITH A BACK UP IOL WITH THE SIMILAR MODEL WITH 12.5 DIOPTER. PRE-OPERATIVE REFRACTION WAS RECORDED AS -4.50 +2.00 X109, WITH BEST SPECTACLE CORRECTED VISUAL ACUITY OF 20/50, WHILE POST-OPERATIVE REFRACTION WAS NOTED AS -1.50 +0.75 X110, ACHIEVING CORRECTED VISUAL ACUITY OF 20/20. THE INITIAL TARGET OF REFRACTION WAS PLANO (-0.25). THE PATIENT WAS NOTED AS "RECOVERING" AND ACHIEVING UNCORRECTED VISUAL ACUITY OF 20/20 ONE WEEK AFTER THE OPERATION. NO SUTURES, INCISION ENLARGEMENT OR VITRECTOMY REQUIRED. NO MEDICATIONS OUTSIDE OF STANDARD OF CARE WERE PRESCRIBED. THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO

  Patient problems: Visual Disturbances; Visual Impairment

  MAUDE report 24258783 ↗
• InjuryAug 14, 2023Adverse 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 IN A SECONDARY PROCEDURE DUE TO BLURRY VISION IN THE LEFT EYE. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (SAME MODEL, DIFFERENT CYLINDER OF 2.25, SAME DIOPTER). AN INCISION ENLARGEMENT WAS REQUIRED. THERE WAS NO PATIENT INJURY. THE PATIENT STATUS WAS REPORTED AS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 17547259 ↗