TECNIS IOL ZKB00 (REF ZKB00U0140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474559967), received between Aug 25, 2016 and Mar 21, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZKB00 14.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS). IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE DIOPTER POWER WAS WRONG FOR THE PATIENT. THERE WAS AN INCISION ENLARGEMENT PERFORMED, BUT NO VITRECTOMY AND NO SUTURES WERE USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 17.0. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7356946 ↗
• InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A THAT A ZKB00 14.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A FEMALE PATIENT¿S EYE DUE TO THE PATIENT NEEDED A VICTRECTOMY. THROUGH FOLLOW UP ADDITIONAL INFORMATION WAS PROVIDED. IT WAS NOTED THERE WAS A MECHANICAL ISSUE WITH THE LENS. THE SURGEON BROUGHT THE PATIENT BACK TO THE OPERATING ROOM TWO (2) WEEKS POST IMPLANT TO EXPLANT THE LENS AND REPLACE IT WITH A NON AMO ANTERIOR CHAMBER LENS. THERE WAS NO CAPSULE TEAR OR INCISION ENLARGEMENT REQUIRED TO REMOVE THE LENS. CLARIFICATION WAS REQUESTED TO SPECIFY WHAT KIND OF MECHANICAL ISSUE OF THE LENS WAS NOTED. THE RESPONSE WAS THAT THE PATIENT JUST NEEDED A DIFFERENT POWER LENS BECAUSE OF THE VITRECTOMY PERFORMED AFTER THE LENS WAS IMPLANTED. NOTHING TECHNICALLY WRONG WITH THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6562151 ↗
• InjuryAug 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT COULD SEE 20/20 BUT JUST WAS NOT VERY HAPPY AND IS VERY DISTRESSED WITH BLURRY VISION. A NON-AMO LENS WAS USED AS THE REPLACEMENT LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. ADDITIONALLY, THERE WAS NO POST-OP INJURY NOTED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 5905275 ↗