TECNIS IOL ZKB00 (REF ZKB00U0250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474560185), received between Feb 14, 2020 and Jul 6, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.

• InjuryJul 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 RIGHT EYE DUE TO GLARE AND HALO. ANOTHER LENS OF DIFFERENT MODEL, DIB00 24.5 DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND PATIENT WAS DOING FINE. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 12125739 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED HAVING ISSUES WITH HER IMPLANTED LENSES. THE PATIENT INDICATED THAT HER SYMPTOMS STARTED IMMEDIATELY AFTER SHE HAD THE CATARACT SURGERIES TWO YEARS AGO. THE PATIENT HAS BEEN HAVING DRY EYE AND HAS BEEN TREATED WITH SEVERAL DIFFERENT BRANDS OF EYE DROPS WHICH HAVE NOT HELPED. THE PATIENT IS EXTREMELY INTOLERANT TO LIGHTS, ESPECIALLY DAY LIGHT. THE PATIENT WATCHES TV WITH YELLOW GLASSES AND STATED BLUE ONES DO NOT HELP WITH THE LIGHT ISSUES. HER EYES FEEL VERY TIRED AND ACHY. THE PATIENT STATED THAT SHE INITIALLY HAD ISSUES WITH HALOS WHICH WENT AWAY, BUT HER LIGHT SENSITIVITY REMAINS TO DATE. THE PATIENT WAS GIVEN STEROID DROPS FOR FEW WEEKS A YEAR AGO AS HER EYES WERE ACHY AND INFLAMED. THE PATIENT REPORTED THAT HER VISION IS NOT AS GOOD AS IT USED TO BE AND SHE HAS BURNING/FOREIGN BODY SENSATION AS THOUGH THERE IS SAND IN HER EYES. EVERY MONTH SHE HAS BEEN SEEING HER DOCTOR AND ON ONE OCCASION, HER DOCTOR PRESCRIBED A COMBO ANTIBIOTICS/STEROID WHICH SEEMED TO HELP, BUT SHE FINISHED THAT ABOUT A MONTH AGO. REPORTEDLY, HER DOCTOR DILATED HER EYES AND FOUND SCAR TISSUE. THE DOCTOR TOLD THE PATIENT THAT HE CAN EITHER REMOVE/REPLACE THE LENSES WHICH MAY BE RIS

  Patient problems: Discomfort; Dry Eye(s); Foreign Body Sensation in Eye

  MAUDE report 10435267 ↗
• InjuryFeb 14, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO THE WRONG POWER. THERE WAS NO PATIENT INJURY AND NO SURGICAL INTERVENTION. THE PATIENT WAS DOING OKAY POST-OP. A REQUEST WAS MADE FOR ADDITIONAL INFORMATION BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9710147 ↗