TECNIS IOL ZKB00 (REF ZKB00U0120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474559929), received between Nov 29, 2016 and Jun 9, 2021 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO INADEQUATE CLARITY OF VISION. THERE WAS NO VITRECTOMY OR SUTURES REQUIRED. NO MEDICATION WAS PRESCRIBED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE EXPLANTED LENS WAS DISCARDED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL ZCB00 AND HIGHER DIOPTER 16.5) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT.

  Patient problems: Blurred Vision

  MAUDE report 11963942 ↗
• InjuryJan 5, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM RIGHT EYE DUE TO WRONG POWER. THERE WAS NO VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121529 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO THE PATIENT COMPLAINING OF HALOS, GLARE, AND PROBLEMS DRIVING AT NIGHT. THE LENS WAS REPLACED WITH A Z9002 12.5 DIOPTER IOL. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6953435 ↗
• InjuryNov 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT WAS EXPERIENCING HALOS AND GLARE AFTER IMPLANTATION OF A ZLB00 INTRAOCULAR LENS (IOL) IN THE LEFT EYE AND A ZKB00 IOL IN THE RIGHT EYE. THE PATIENT STATED THAT SHE HAS BEEN HAVING FUZZY RINGS/HALOS AROUND LIGHT. OVER TIME, THE FUZZY RINGS GOT BIGGER. HER NIGHT VISION IS COMPROMISED, HAS DIFFICULTY READING BECAUSE OF THE HALOS. THIS REPORT WILL CAPTURE THE ZKB00 12.0 DIOPTER IMPLANTED ON (B)(6) 2016 IN THE RIGHT EYE AND A SEPARATE MDR WILL BE FILED FOR THE ZLB00 IOL.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 6134100 ↗