TECNIS IOL ZKB00 (REF ZKB00U0245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474560178), received between Dec 8, 2016 and Mar 16, 2023 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMar 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE DUE TO HALO, GLARE, AND POOR CONTRAST. NO OTHER VISUAL DISTURBANCES WERE EXPERIENCED. THE SYMPTOMS WERE FIRST NOTED FROM THE DATE OF IMPLANT ON (B)(6) 2022 DURING A POST-OPERATIVE EXAM. THE SYMPTOMS IMPROVED BUT DID NOT RESOLVED, RESULTING IN THE EXCHANGE. A NON-JOHNSON AND JOHNSON MONOFOCAL IOL WAS IMPLANTED AS REPLACEMENT. THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THE PATIENT'S SYMPTOMS HAVE IMPROVED POST-OPERATIVE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 16554602 ↗
• InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED HAVING ISSUES WITH HER IMPLANTED LENSES. THE PATIENT INDICATED THAT HER SYMPTOMS STARTED IMMEDIATELY AFTER SHE HAD THE CATARACT SURGERIES TWO YEARS AGO. THE PATIENT HAS BEEN HAVING DRY EYE AND HAS BEEN TREATED WITH SEVERAL DIFFERENT BRANDS OF EYE DROPS WHICH HAVE NOT HELPED. THE PATIENT HAS EXTREMELY INTOLERANT TO LIGHTS, ESPECIALLY DAY LIGHT. THE PATIENT WATCHES TV WITH YELLOW GLASSES AND STATED BLUE ONES DO NOT HELP WITH THE LIGHT ISSUES. HER EYES FEEL VERY TIRED AND ACHY. THE PATIENT STATED THAT SHE INITIALLY HAD ISSUES WITH HALOS WHICH WENT AWAY, BUT HER LIGHT SENSITIVITY REMAINS TO DATE. THE PATIENT WAS GIVEN STEROID DROPS FOR FEW WEEKS A YEAR AGO AS HER EYES WERE ACHY AND INFLAMED. THE PATIENT REPORTED HER VISION IS NOT AS GOOD AS IT USED TO BE AND SHE HAS A BURNING/FOREIGN BODY SENSATION AS THOUGH THERE IS SAND IN HER EYES. EVERY MONTH SHE HAS BEEN SEEING HER DOCTOR, AND ON ONE OCCASION, HER DOCTOR PRESCRIBED A COMBO ANTIBIOTICS/STEROID WHICH SEEMED TO HELP, BUT SHE FINISHED THAT ABOUT A MONTH AGO. REPORTEDLY, HER DOCTOR DILATED HER EYES AND FOUND SCAR TISSUE. THE DOCTOR TOLD THE PATIENT THAT HE CAN EITHER REMOVE/REPLACE THE LENSES WHICH MAY BE RISK

  Patient problems: Discomfort; Dry Eye(s); Foreign Body Sensation in Eye

  MAUDE report 10435263 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE PATIENT BEING UNABLE TO SEE CLEARLY. THE IOL WAS REPLACED WITH THE SAME MODEL ZKB00 BUT HIGHER DIOPTER, 26.0. THRU FOLLOW-UP, THE CUSTOMER EXPLAINED THAT THEY ENDED UP PUTTING IN A DIFFERENT POWER IOL TO SEE IF THAT WAS THE PROBLEM. THE IOL MASTER THAT WAS PERFORMED CALLED FOR THE POWER THAT WAS ORIGINALLY PUT IN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9709118 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATENT'S LEFT EYE (OS) ON (B)(6) 2018. POST-OPERATIVELY, THE FOLLOWING DAY, THE PATIENT REPORTED EXPERIENCING BLURRY VISION AND HALOS AROUND TRAFFIC LIGHTS AND TAIL LIGHTS AT NIGHT WHEN DRIVING. THE DOCTOR INFORMED THE PATIENT THAT THE SYMPTOMS WERE STARBURSTS, BUT THE PATIENT DENIES THE STARBURSTS STATING THEY ARE ACTUALLY HALOS. CURRENTLY, THERE ARE NO PLANS OF ANY INTERVENTION AND THE PATIENT WILL CONTINUE TO FOLLOW UP WITH THE DOCTOR. THE PATIENT ALSO STATED THAT HE EXPERIENCED NO INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 8313015 ↗
• InjuryFeb 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. POST-OPERATIVELY, THE FOLLOWING DAY, THE PATIENT REPORTED EXPERIENCING BLURRY VISION AND HALOS AROUND TRAFFIC LIGHTS AND TAIL LIGHTS AT NIGHT WHEN DRIVING. THE DOCTOR INFORMED THE PATIENT THAT THE SYMPTOMS WERE STARBURSTS, BUT THE PATIENT DENIES THE STARBURSTS STATING THEY ARE ACTUALLY HALOS. CURRENTLY, THERE ARE NO PLANS OF ANY INTERVENTION AND THE PATIENT WILL CONTINUE TO FOLLOW UP WITH THE DOCTOR. THE PATIENT ALSO STATED THAT HE EXPERIENCED NO INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Halo

  MAUDE report 8312922 ↗
• InjuryJun 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 24.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE AND WAS LATER EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7640942 ↗
• InjuryJun 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A PATIENT WHO IS A CARPET CLEANER REPORTED THAT HE COULD NOT SEE UNDER ULTRA VIOLENT (UV) LIGHTS WHEN DOING INSPECTION AS PART OF HIS JOB. THE SYMPTOMS BEGAN AFTER THE PATIENT HAD HIS SECOND LENS IMPLANT ON (B)(6) 2016. ACCORDING TO THE CLINICAL SITE, IT WAS RECOMMENDED THAT THE PATIENT SHOULD TRY TO USE A DIFFERENT UV BLACK LIGHT (SOMETHING THAT EXCEEDS 40 NANOMETER). WHEN THE PATIENT RETURNED FOR A FOLLOW UP IN (B)(6) 2017, THE PATIENT DID NOT MENTION ANYTHING ABOUT HIS UV BLACK LIGHT ISSUE. THE PATIENT WAS MEASURED AND OVERALL, HIS VISION WAS PERFECT. THE FOLLOW UP PROVIDED STATED THAT THERE WAS NO PLAN TO EXPLANT THE LENSES, ESPECIALLY SINCE THE LENS HAS BEEN IMPLANTED FOR A WHILE NOW AND THAT THE PATIENT DID NOT REALLY HAVE A CONCERN DURING HIS LAST FOLLOW UP VISIT. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6615294 ↗
• InjuryMay 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER BILATERAL IMPLANTS OF MODEL ZKB00, 24.5 AND ZKB00, 24.0 DIOPTER INTRAOCULAR LENSES (IOL), THE PATIENT HAD BEEN SEEING LIGHTS UPON LIGHTS. PATIENT IS UNABLE TO DRIVE AS THE LIGHTS LOOKS LIKE FIREWORKS WHEN DRIVING. PATIENT STATED THAT HER SYMPTOMS ACTUALLY APPEAR ONLY AT NIGHT TIME. DURING THE DAY HER VISION IS OK. BUT WHEN NIGHT TIME COMES, SHE'S HAVING THE SYMPTOMS OF LIGHTS UPON LIGHTS WHICH OCCURRED GRADUALLY. SHE'S NOT SURE OF WHEN EXACTLY THEY STARTED. THIS REPORT WILL CAPTURE THE ZKB00 24.5 DIOPTER (D) IMPLANTED ON (B)(6) 2016, AND A SEPARATE REPORT WILL FILED FOR THE ZKB00 24.0 D LENS.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6539307 ↗
• MalfunctionDec 8, 2016Material Puncture/Hole; Device Damaged by Another Device; Material Puncture/Hole; Device Damaged by Another Device

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS PUNCTURED BY THE INSERTER DURING INSERTION INTO THE EYE. INFORMATION FOR INSERTER OR CARTRIDGE WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 6155689 ↗