TECNIS IOL ZKB00 (REF ZKB00U0150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474559981), received between Jun 14, 2019 and Apr 8, 2020 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE PARTLY DUE TO RESIDUAL ASTIGMATISM. THE PATIENT ALSO COMPLAINED OF NOT SEEING WELL AT DISTANCE AND NEAR DESPITE FUNCTIONAL ACUITY AT NEAR AND DISTANCE. THE REPLACEMENT IOL IS A SYMFONY TORIC AND REPORTEDLY, THE PATIENT'S VISUAL ACUITY IS MUCH BETTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected; Visual Impairment

  MAUDE report 9936543 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZKB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2017, PER PATIENT IMPLANT CARD. IOL WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF GLARE. IT WAS REPORTED THERE WAS A PARS PLANA VITRECTOMY AND LIMBAL RELAXING INCISION (LRI) PERFORMED. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, AND ZKB00 LENS WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. PATIENT REPORTED VISUAL ACUITY (VA) HAS IMPROVED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8975822 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZKB00 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO HYPEROPIC SHIFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ZKB00 LENS WITH A HIGHER DIOPTER. THERE IS NO INCISION ENLARGEMENT OR SUTURE NEEDED. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE RIGHT EYE. THE LEFT EYE WILL BE SUBMITTED UNDER A SEPARATE REPORT.

  Patient problems: No Code Available

  MAUDE report 8702085 ↗