TECNIS IOL ZKB00 (REF ZKB00U0260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474560208), received between Jan 31, 2018 and Jun 13, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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.

• InjuryJun 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT'S RIGHT EYE SHIFTED, AND THERE WAS A MYOPIC SHIFT. THE IOL WAS EXCHANGED WITH ANOTHER IOL OF THE SAME MODEL BUT .5 DIOPTER LOWER. THE PATIENT IS DOING WELL POST-EXCHANGE. THERE WAS NO ADDITIONAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION REPORTED THE MYOPIC SHIFT WAS A RESULT OF THE LENS SHIFT AND THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8694388 ↗
• InjurySep 26, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +26.0 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE LENS WAS EXPLANTED DUE TO PATIENT EXPERIENCING MECHANICAL COMPLICATIONS; UNABLE TO SEE NEAR AND DISTANCE VISION CLEARLY. REPORTEDLY, THE LENS WAS REPLACED WITH THE SAME MODEL, A +27.0, A LARGER DIOPTER AND PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 7912797 ↗
• InjuryJan 31, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00 +26.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT COMPLAINING OF UNSATISFACTORY VISUAL OUTCOME. TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00 +25.0 DIOPTER) WAS IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7231911 ↗