TECNIS IOL ZKB00 (REF ZKB00U0115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474559912), received between Mar 1, 2017 and Jun 12, 2020 — 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.

• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10149160 ↗
• InjuryJul 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 11.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED AND REPLACED WITH A NON AMO DEVICE. THERE WAS NO INCISION ENLARGEMENT AND NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6729148 ↗
• InjuryMar 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS WAS EXPLANTED AS THE PATIENT WAS NOT SATISFIED WITH THE VISUAL OUTCOME. THERE WAS NO INCISION ENLARGEMENT, NO INJURY AND NO SUTURES REQUIRED. THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS.

  Patient problems: No Code Available

  MAUDE report 6370898 ↗