TECNIS IOL ZKB00 (REF ZKB00U0135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474559950), received between Nov 15, 2016 and Jul 3, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT A SCUFF WAS NOTICED ON A ZKB00 13.5 DIOPTER LENS WHEN INSERTED INTO THE PATIENT'S OPERATIVE EYE. ANOTHER LENS WAS USED TO COMPLETE THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7660109 ↗
• InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 13.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT COMPLAINED OF NOT BEING ABLE TO SEE WITH THE LENS IMPLANT. THE LENS WAS REPLACED WITH A NON-AMO IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6912588 ↗
• InjuryAug 29, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZKB00 13.5 DIOPTER WAS EXPLANTED FROM THE RIGHT EYE DUE TO THE PATIENT COMPLAINING OF DECREASED VISION AND THE LENS WAS SUBLUXED. A ZKB00 12.5 DIOPTER WAS THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6829406 ↗
• InjuryAug 29, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED A (B)(4) DIOPTER WAS EXPLANTED DUE TO THE PATIENT COMPLAINING OF DECREASED VISION. REPORTEDLY, THE LENS WAS SUBLUXED AND THE LENS WAS REPLACED WITH THE SAME MODEL BUT DIFFERENT DIOPTER (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6829308 ↗
• InjuryNov 15, 2016Adverse 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 THE RIGHT EYE OF THE PATIENT DUE TO DYSPHOTOPSIA. THE PATIENT COMPLAINED OF HALOS AND POOR VISION BECAUSE OF THEM. THE REPLACEMENT LENS WAS A MONOFOCAL OF A LOWER DIOPTER (12.5). NO POST OP PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6105072 ↗