TECNIS IOL ZKB00 (REF ZKB00U0125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474559936), received between Nov 13, 2017 and May 30, 2023 — classified as 4 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 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.

• InjuryMay 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZKB00 INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENTS RIGHT EYE DUE TO GLARES, BLURRY VISION AND STARBURST. THERE WAS NO PATIENT INJURY AND NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE ZKB00 12.5 DIOPTER LENS WAS REPLACED IN A SECONDARY PROCEDURE WITH DIB00 13 DIOPTER LENS. PATIENT WAS DOING WELL. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Flashers; Visual Disturbances

  MAUDE report 17022850 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE (OS) DUE TO GLARE SENSITIVITY. PATIENT ALSO EXPERIENCED STARBURST DAY AND NIGHT. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY, BUT THERE WAS INCISION ENLARGED TO REMOVE THE LENS. PATIENT WAS DOING WELL POST-SURGERY. THE LENS WAS REPLACED WITH A MONOFOCAL MODEL AR40. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7799357 ↗
• InjuryNov 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE THE PATIENT WAS NOT PLEASED WITH THE DISTANCE OR NEAR VISION. REPORTEDLY, THE DOCTOR WENT WITH A STANDARD IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7062100 ↗
• InjuryNov 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) BECAUSE OF INTOLERABLE DYSPHOTOPSIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7025514 ↗