TECNIS IOL ZKB00 (REF ZKB00U0175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474560031), received between Aug 25, 2016 and Jan 30, 2025 — classified as 9 injuries, 1 malfunction.

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

• MalfunctionJan 30, 2025Break; Break

  THE REPORT INDICATED THAT UPON THE INSERTION OF A MULTIFOCAL INTRAOCULAR LENS (IOL) INTO A PATIENT'S EYE, THE SURGEON OBSERVED A CRACK IN THE LENS. HE WAS UNCERTAIN WHETHER THE CRACK WAS CAUSED BY THE FOLDING PROCESS, THE CARTRIDGE USED FOR INSERTION, OR A DEFECT IN THE LENS ITSELF. ADDITIONAL INFORMATION SUGGESTS THAT NO INTERVENTIONS WERE NEEDED AND THE SAME MODEL AND DIOPTER WERE SUCCESSFULLY INSERTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21275577 ↗
• InjurySep 3, 2021Adverse 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 PATIENT'S RIGHT EYE AS THE PATIENT HAD BLURRY VISION AND IMBALANCE BETWEEN THE EYES. A COMPETITOR LENS WAS PLACED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY REPORTED AND NO OTHER INTERVENTION WAS REQUIRED. THE PATIENT WAS DOING GOOD POST-OPERATION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 12424600 ↗
• InjuryJan 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE WRONG POWER. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL, LOWER DIOPTER 16.5) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Insufficient Information

  MAUDE report 11121847 ↗
• InjuryJan 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A MODEL ZKB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) MODEL WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE LENS WAS SUBSEQUENTLY EXPLANTED DUE TO PATIENT COMPLAINT OF HALOS. PATIENT OUTCOME WAS REPORTED AS OKAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9651277 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZKB00 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO THE PATIENT EXPERIENCING HAZING, HALOS, AND GLARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NON-JOHNSON AND JOHNSON LENS. THERE WAS NO INCISION ENLARGEMENT OR SUTURE REQUIRED. THE PATIENT IS HAPPY AND DOING WELL POST-OPERATIVELY. 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: Blurred Vision; Halo; No Code Available

  MAUDE report 8701997 ↗
• InjuryDec 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 17.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT DID NOT RECEIVE THE DESIRED NEAR VISION RESULTS WANTED. REPORTEDLY, THE PATIENT IS UNABLE TO READ AT NEAR WITHOUT GLASSES. THERE WAS NO INCISION ENLARGEMENT AND THE OUTCOMES DO NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE WAS ALSO NO VITRECTOMY PERFORMED AND NO SUTURES USED. THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE EXPLANTED LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8183359 ↗
• InjuryFeb 27, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL), 17.5 DIOPTER WAS EXPLANTED FROM THE RIGHT EYE (OD) OF A MALE PATIENT DUE TO A DECENTERED LENS. THE REPLACEMENT LENS WAS A ZMA00 17.0 DIOPTER INTRAOCULAR LENS, IMPLANTED IN THE SULCUS. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES REQUIRED, AND NO VITRECTOMY WAS PERFORMED. IT WAS REPORTED THAT THE PATIENT IS STABLE, GOOD AND NO PATIENT POST-OP INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7301121 ↗
• InjuryAug 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 17.5 INTRAOCULAR LENS IOL WAS EXPLANTED/EXCHANGED AS THE PATIENT HAD RESIDUAL CYLINDER OF ONLY .75. IT'S REPORTED THAT IT REALLY MADE A DIFFERENCE WHEN CORRECTED. THE SURGEON EXCHANGED THE ZKB00 FOR A MODEL ZXT IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6787051 ↗
• InjurySep 14, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN EXPLANT OF AN INTRAOCULAR LENS(IOL), MODEL ZKB00 WAS PERFORMED ON THE RIGHT (OD) EYE OF A FEMALE PATIENT DUE TO WRONG POWER. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED AND THERE WAS NO PATIENT INJURY POST-OP REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5951502 ↗
• InjuryAug 25, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A ZKB00 INTRAOCULAR LENS WAS EXPLANTED FROM THE RIGHT EYE OF A PATIENT. THE REASON FOR THE EXPLANT IS UNKNOWN. THE INCISION WAS ENLARGED. NO SUTURES WERE REQUIRED. THERE WAS NO PATIENT INJURY. ANOTHER LENS OF THE SAME MODEL BUT A HIGHER DIOPTER WAS IMPLANTED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5904786 ↗