TECNIS IOL ZKB00 (REF ZKB00U0170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474560024), received between Nov 21, 2016 and Jun 8, 2021 — classified as 10 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO DISLOCATED IOL. A REPLACEMENT LENS OF DIFFERENT MODEL AND DIOPTER (15.5 D) WAS USED. IT WAS INDICATED THAT A VITRECTOMY WAS PERFORMED. THE PATIENT IS DOING FINE POST-OP AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11963532 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZKB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT 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 POSTOPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED. PATIENT HAS BILATERAL IMPLANTS. THIS REPORT REPRESENTS THE LEFT EYE. THE RIGHT EYE WILL BE SUBMITTED UNDER A SEPARATE REPORT.

  Patient problems: No Code Available

  MAUDE report 8702098 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZKB00 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT EXPERIENCING HALOS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-JOHNSON AND JOHNSON LENS. THERE IS NO INCISION ENLARGEMENT OR SUTURE REQUIRED. THE PATIENT IS DOING GOOD POSTOPERATIVELY. 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: Halo; No Code Available

  MAUDE report 8702038 ↗
• InjuryJun 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO PATIENT COMPLAINT OF BLURRY VISION AND TROUBLE WITH READING. THE PATIENT'S VISUAL ACUITY WERE REPORTED AS FOLLOWS: PRE-OP: 20/25, J2 WITH CORRECTION; 20/400 GLARE TEST. AT 6-DAY POST-OP: UNCORRECTED (UC) 20/60+, J20S; AT 2-WEEKS POST-OP UC 20/40, J10. NO INCISION ENLARGEMENT, NO SUTURES, NO VITRECTOMY WERE PERFORMED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8669396 ↗
• InjuryJun 13, 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 RIGHT EYE (OD) DUE TO PATIENT BEING UNHAPPY WITH HER VISION, SHE THOUGHT IT WAS TOO STRONG. THE EXPLANTED LENS WAS REPLACED WITH A SAME LENS MODEL BUT A DIFFERENT DIOPTER. PER FOLLOW-UP, THERE WERE NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. IT WAS NOTED ALSO THAT THERE WAS NO POST-OPERATIVE INJURY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7595203 ↗
• InjuryFeb 22, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +17.0 DIOPTER) WAS EXPLANTED FROM PATIENT''S LEFT EYE IN A SECONDARY PROCEDURE. REPORTEDLY THE LENS DECENTERED POST IMPLANTATION AND THERE WAS UNEXPECTED POST OP REFRACTION. MODEL ZMA00, +16.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED AS THE REPLACEMENT LENS IN THE SULCUS WITH NO COMPLICATIONS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7290930 ↗
• InjuryAug 30, 2017Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ZKB00 INTRAOCULAR LENSES (IOLS) IMPLANTED INTO BOTH EYES (OU) SINCE SHE WANTED TO READ NEAR HAVING BEEN MYOPIC (-4.50). THERE WAS NO REPORTED ISSUES WITH THE LEFT EYE. THE RIGHT EYE, WHICH HAD A ZKB00 17.0 DIOPTER, CAME OUT WITH A REFRACTIVE SURPRISE OF +1.00 +0.25 X 75 POST-OPERATIVELY. THE PATIENT IS REPORTEDLY NOT HAPPY AND AN EXPLANT WAS PERFORMED ON (B)(6) 2017 DUE TO POOR VISUAL RESULTS. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6829453 ↗
• InjuryMar 17, 2017Adverse 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 IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT COMPLAINED OF SEVERE GLARE AND ISSUES AT NIGHT. REPORTEDLY, ANOTHER LENS WAS IMPLANTED (UNKNOWN MODEL AND DIOPTER). THERE WERE NO FURTHER COMPLICATIONS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6415476 ↗
• InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, IT WAS REPORTED THAT A PATIENT IS EXTREMELY UNHAPPY WITH THE RESULTS AND COMPLAINED ABOUT HALOS AFTER IMPLANTATION OF A ZKB00 INTRAOCULAR LENS (IOL). REPORTEDLY, PHYSICIAN STATED THAT THE PATIENT IS 20/20, AND HE COULDN'T ASK FOR A BETTER RESULT CLINICALLY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 STATING THAT AS OF LAST WEEK, PATIENT IS STILL 20/20 IN BOTH EYES, BUT STILL VERY FRUSTRATED WITH GLARE IN BOTH EYES. THIS REPORT REPRESENTS THE LENS IMPLANTED IN PATIENT'S RIGHT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6119117 ↗
• InjuryNov 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016, IT WAS REPORTED THAT A PATIENT IS EXTREMELY UNHAPPY WITH THE RESULTS AND COMPLAINED ABOUT HALOS AFTER IMPLANTATION OF A ZKB00 INTRAOCULAR LENS (IOL). REPORTEDLY, PHYSICIAN STATED THAT THE PATIENT IS 20/20, AND HE COULDN'T ASK FOR A BETTER RESULT CLINICALLY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2016 STATING THAT AS OF LAST WEEK, PATIENT IS STILL 20/20 IN BOTH EYES, BUT STILL VERY FRUSTRATED WITH GLARE IN BOTH EYES. THIS REPORT REPRESENTS THE LENS IMPLANTED IN PATIENT'S LEFT EYE. A SEPARATE REPORT IS BEING FILED FOR THE LENS IMPLANTED IN PATIENT'S RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 6119111 ↗