TECNIS IOL ZKU150 (REF ZKU150U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474686991), received between Mar 21, 2023 and Sep 4, 2024 — 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. 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.

• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TWO PRELOADED INTRAOCULAR LENSES(IOL) WERE IMPLANTED AND EXPLANTED FROM THE LEFT EYE OF THE PATIENT. THE FIRST LENS (ZKU150U185, S/N (B)(6) WAS IMPLANTED IN THE PATIENT'S EYE AND EXPLANTED DUE TO BLURRY VISION AND REPLACED WITH SAME MODEL AND DIOPTER LENS (S/N: (B)(6) IN A SECONDARY PROCEDURE. THE PATIENT COMPLAINED OF BLURRY VISION WITH THE REPLACED SECOND LENS TOO. THE REPLACED SECOND LENS WAS EXPLANTED AND REPLACED WITH LENS FROM ANOTHER MANUFACTURER IN A SECONDARY PROCEDURE. THERE WERE NO PATIENT ISSUES. PLATINUM CARTRIDGE WAS USED. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 20139269 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE WRONG POWER INTRAOCULAR LENS (IOL) WAS USED, SO THE LENS WAS EXPLANTED FROM THE LEFT EYE IN A SECONDARY PROCEDURE. A NON-JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (3-PIECE MONOFOCAL, DIFFERENT DIOPTER OF 18.0). THERE WAS NO PATIENT INJURY AND NO MEDICAL OR SURGICAL INTERVENTION WAS INDICATED. IT IS UNKNOWN HOW THE PATIENT IS DOING POST-OPERATIVE. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE REASON FOR EXPLANT WAS THAT THE PATIENT COULD NOT TOLERATE THE MULTIFOCAL. AFTER ABOUT A MONTH OF TRYING TO ADAPT TO THE MULTIFOCAL, THE PATIENT COULD NOT. PRE-OPERATIVE BEST CORRECTED VISUAL ACUITY (VA) WAS 20/20. POST-OPERATIVE (INITIAL IMPLANT) BEST CORRECTED VA WAS 20/20. THE INTENDED TARGET REFRACTION WAS PLANO. POST-OPERATIVE BEST CORRECTED VISUAL ACUITY (POST-REPLACEMENT IMPLANT) WAS 20/20. THERE WAS NO CALCULATION ISSUE. THE PATIENT OUTCOME AT DISCHARGE WAS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 16748035 ↗
• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZKU150 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS, DIOPTER SIZE UNKNOWN, DUE TO PATIENT NOT HAPPY WITH MULTIFOCAL LENS. THERE WAS NO PATIENT INJURY, NO MEDICAL INTERVENTION, AND NO SURGICAL INTERVENTIONS. PATIENT STATUS POST-OPERATIVELY IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 16587679 ↗