TECNIS IOL ZKB00 (REF ZKB00U0130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474559943), received between Jun 14, 2017 and Jul 15, 2020 — classified as 4 injuries, 1 malfunction.

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 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.

• InjuryJul 15, 2020Adverse 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 LEFT EYE BECAUSE THE PATIENT COULD NOT TOLERATE THE IMPLANTED IOL (DISABLING GLARE AND STARBURST). THIS SUSPECT IOL WAS REPLACED WITH A MODEL PCB00 13.5 DIOPTER LENS. IT WAS LEARNED THAT THE PATIENT HAS RECOVERED. THE SUSPECT PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10277082 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE MULTIFOCAL ZKB00 +13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2018. REPORTEDLY, THE PATIENT WAS EXPERIENCING DYSPHOTOPSIA THEREFORE THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A MONOFOCAL PCB00 +13.5 DIOPTER LENS. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO SUTURES WERE USED AND NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS REPORTED IN GOOD SPIRIT WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8048582 ↗
• InjuryApr 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COULD NOT TOLERATE THE EXPERIENCE OF HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7420855 ↗
• MalfunctionOct 14, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS TORN DURING INSERTION INTO THE EYE. THERE WAS NO PATIENT INJURY, NO COMPLICATIONS, NO INCISION ENLARGEMENT, NO VITRECTOMY. THE IOL WAS REMOVED DURING THE SAME PROCEDURE. THE IOL WAS REPLACED WITH ANOTHER IOL OF THE SAME MODEL AND DIOPTER. THERE WERE NO ISSUES AFTER THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6950556 ↗
• InjuryJun 14, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZKB00 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A WRONG POWER LENS. ADDITIONAL INFORMATION CLARIFIED THAT THE DOCTOR CHOOSE THE WRONG POWER LENS FOR THE PATIENT WHO ENDED UP WITH UNEXPECTED POST OP REFRACTION IN THEIR RIGHT EYE. THE LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER, 11.5 DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6641070 ↗