TECNIS IOL ZKB00 (REF ZKB00U0165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474560017), received between Oct 11, 2016 and Mar 5, 2024 — classified as 10 injuries.

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

• InjuryMar 5, 2024Adverse 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 FROM THE PATIENT'S LEFT EYE DUE TO BLURRY VISION. THE ISSUE WAS FIRST KNOWN DURING POST-OP VISIT. THE INCISION WAS ENLARGED. THE EXPLANTED LENS WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL OF 17.0 DIOPTER. IT WAS NOTED THAT THE REPLACEMENT LENS HELPED ADDRESS THE PATIENT¿S CONCERNS AND THE PATIENT IS NOW DOING GOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 18842046 ↗
• InjuryJul 29, 2021Adverse 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 FROM THE PATIENT'S RIGHT EYE DUE TO POOR VISION. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON REPLACEMENT LENS. AND THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 12250477 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S EYE DUE TO THE PATIENT NOT BEING ABLE TO ADJUST TO A MULTIFOCAL. A MODEL ZCB00 LENS WITH A HIGHER DIOPTER (17.5) WAS IMPLANTED AS THE REPLACEMENT. FURTHER MEDICAL INTERVENTION WAS NOT REQUIRED. IT WAS INDICATED RESULTS FOR UDVA (UNCORRECTED DISTANCE VISUAL ACUITY) = DAY 1 20/16-1. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11586552 ↗
• InjurySep 1, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A TECNIS MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO MECHANICAL COMPLICATION. ADDITIONAL SURGICAL INTERVENTION WAS NOT REQUIRED. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10475424 ↗
• InjuryAug 7, 2020Adverse 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 DUE TO PATIENT EXPERIENCING HALOS, GLARE, AND SOME STREAKS OF LIGHT THAT WERE DISABLING. THE INCISION WAS SLIGHTLY ENLARGED, HOWEVER, SUTURES AND A VITRECTOMY WERE NOT REQUIRED. THERE WERE NO COMPLICATIONS WITH THE EXCHANGE. THE IOL WAS DISCARDED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND SAME DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THERE IS EXCELLENT INTRAOPERATIVE RESULT AND POST OPERATIVE OUTCOME VERY PLEASED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 10382848 ↗
• InjuryJul 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO INCORRECT LENS POWER. THERE WAS NO INCISION ENLARGEMENT OR SUTURE REQUIRED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, PATIENT IS DOING GOOD POST-EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8843981 ↗
• InjuryDec 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 16.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. THE LENS REMAINS IMPLANTED, BUT AN AR40 MODEL LENS WITH 1.0 DIOPTER WAS IMPLANTED IN THE PATIENT'S LEFT EYE AS A PIGGYBACK. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. REPORTEDLY, THE PATIENT IS DOING OKAY. INTRAOCULAR LENS (IOL) MASTER RESULTS INDICATED THAT THE A CONSTANT USED WAS CORRECT (119.3 SRKT). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8136655 ↗
• InjuryOct 24, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZKB00 +16.5 DIOPTER) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE ON (B)(6) 2018. REPORTEDLY, THE PATIENT ENDED UP HYPEROPIC WITH A +1 DIOPTER REFRACTION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT EXPERIENCED BLURRY VISION SINCE THE SURGERY. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A ZKB00 +18.0 DIOPTER. THE SURGEON COMMENTED THAT THE HYPEROPIC SURPRISE WAS DUE TO PATIENT ANATOMY FROM PRIOR LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS) PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8003032 ↗
• InjuryDec 16, 2016Adverse 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 FROM A PATIENT'S EYE DUE TO THE PATIENT COMPLAINING OF HALOS. ANOTHER LENS, DIFFERENT MODEL, WAS USED AS A REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6183001 ↗
• InjuryOct 11, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZKB00 16.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO MECHANICAL COMPLICATION WITH VITREOUS PROLAPSE. DURING EXPLANT, VITRECTOMY WAS REQUIRED. IN THE FOLLOW-UP IT WAS LEARNED THAT THE LENS WAS NOT SAVED FOR RETURN. SURGERY WAS SUCCESSFUL. ADDITIONALLY, IT WAS FURTHER CLARIFIED THAT THE LENS DECENTERED, PATIENT WAS UNHAPPY. PHYSICIAN DID NOT INDICATE IF THERE WAS AN ISSUE WITH PRODUCT QUALITY OR WITH PATIENT ANATOMY. HOWEVER, AFTER THE REPLACEMENT LENS WAS IMPLANTED, THE PATIENT WAS HAPPY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6018882 ↗