TECNIS IOL ZKB00 (REF ZKB00U0160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474560000), received between Nov 27, 2016 and Nov 19, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 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 WRONG POWER. NO OTHER REASON FOR EXPLANT WAS SPECIFIED. THE REPLACEMENT LENS WAS OF THE SAME MODEL IOL BUT ONLY 0.5 HIGHER DIOPTER POWER THAT THE ORIGINAL IOL. THERE WAS NO OTHER MEDICAL OR SURGICAL INTERVENTION. NO PATIENT INJURY. THE PATIENT OUTCOME IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 20726981 ↗
• InjuryDec 8, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE DUE TO WRONG POWER. THE IOL WAS REPLACED WITH A NON-JOHNSON & JOHNSON SURGICAL VISION LENS. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION AND THE PATIENT OUTCOME POST-PROCEDURE IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965448 ↗
• InjuryFeb 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019, BECAUSE THE PATIENT'S VISUAL ACUITY WAS NOT DESIRED. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT WAS DOING FINE WHEN HE LEFT SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8299266 ↗
• InjuryApr 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZKB00 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(4) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT NEEDED A HIGHER POWER DIOPTER. THE REPLACEMENT LENS WAS THE SAME MODEL, A DIFFERENT LARGER, DIOPTER OF 17.0. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY. ON (B)(6) 2018, THE PATIENT'S REFRACTION RESULTS WERE 0.50 X -0.50 X 0.15 WITH A VISUAL ACUITY OF 20/25. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7449393 ↗
• InjuryFeb 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE WRONG POWER LENS FOR THE PATIENT. IN FURTHER FOLLOW UP, THE CUSTOMER REPORTED THEY DID NOT HAVE THE DETAILS ON THE REASON FOR EXPLANT OF THE LENS. THEY WERE ABLE TO CONFIRM THE LENS WAS EXPLANTED AND SUCCESSFULLY REPLACED WITH A 17.0 DIOPTER LENS. THERE WERE NO OTHER ISSUES IDENTIFIED AND THE PATIENT WAS REPORTED TO BE FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6367296 ↗
• InjuryNov 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZKB00 INTRAOCULAR LENS(IOL), A PATIENT WAS UNHAPPY. THE PATIENT AT PLANO HAS A VISUAL ACUITY (VA) OF 20/30 ¿ 20/40 AND COMPLAINS OF NO NEAR VA WITH THE ZKB00 IOL. WITH PILOCARPINE, PATIENT IS 20/25 J5. PATIENT WAS OPERATED IN (B)(6) 2016 AND HAS HAD A YAG CAPSULOTOMY. PATIENT ALSO COMPLAINS OF HALOS. LASIK WAS ALSO DONE TO CORRECT RESIDUAL ASTIGMATISM. PATIENT¿S MAIN COMPLAINT IS THAT THE SURGEON CHARGED MORE THAN OTHER DOCTORS WOULD AND IS CLAIMING THAT SHE DOES NOT HAVE A MULTIFOCAL LENS IN HER EYE. THE DOCTOR HAS REFERRED PATIENT TO ANOTHER SURGEON WHO COULD CONFIRM THAT SHE DOES HAVE A ZKB00 IN HER EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6128087 ↗