TECNIS IOL ZKB00 (REF ZKB00U0180)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474560048), received between Jan 19, 2017 and Aug 15, 2023 — classified as 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE IN A SECONDARY PROCEDURE DUE TO DISLOCATION. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (DIFFERENT MODEL ZMA00, DIFFERENT DIOPTER 17.5). THERE WAS NO PATIENT INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT AT THE FIRST POST-OP VISIT ON THE SAME DAY THE LENS WAS IMPLANTED, THE LENS WAS WELL CENTERED. ON THE NEXT DAY, (B)(6) 2023, THE PATIENT CALLED THE SURGEON REPORTING THAT THE EYE WAS RUBBED ACCIDENTALLY (HARD ENOUGH TO SCARE THE PATIENT) AND THE PATIENT STARTED TO EXPERIENCE BLURRY VISION. THE PATIENT HAD A FOLLOW-UP VISIT THE SAME DAY AND IT WAS NOTED THAT THE LENS WAS PARTIALLY SUBLUXED DUE TO A COMPROMISED CAPSULE. THE SURGEON STATED THAT IT IS POSSIBLE THAT THE PATIENT MAY HAVE RUBBED THE EYE HARD ENOUGH TO DISLOCATED THE LENS, BUT THE SURGEON CANNOT CONFIRM THAT THIS WAS THE CAUSE. THE PATIENT DOES NOT HAVE ANY PRE-EXISTING CONDITIONS THAT MAY HAVE CONTRIBUTED TO THE EVENT. AN IOL EXCHANGED WAS NEEDED AND A THREE PIECE LENS (ZMA00) WAS IMPLANTED IN THE SULCUS, "JUST TO BE SAFE". THE SURGERY WAS UNCOMPLICATED. THE PA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Zonular Dehiscence

  MAUDE report 17553675 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL), 18.0 DIOPTER SIZE WAS EXPLANTED DUE TO PATIENT NOT TOLERATING THE IMPLANT BECAUSE OF UNEXPECTED POST-OP REFRACTION. A REPLACEMENT IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER 15.5 DIOPTER SIZE WAS PUT IN. IT WAS STATED THAT THE PATIENT HAD RECOVERED.

  Patient problems: No Code Available

  MAUDE report 9338072 ↗
• InjuryJun 13, 2019Adverse 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 DUE TO THE PATIENT EXPERIENCING HAZING, GLARE AND HALOS. THE LENS WAS REPLACED WITH A NON J&J LENS. PATIENT WAS REPORTED HAPPY AND DOING WELL POST OP. FURTHER INFORMATION REPORTS THE EVENT SYMPTOMS WERE NOTED ON (B)(6) 2018. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8694481 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZKB00 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S LEFT EYE ON (B)(6) 2019. REPORTEDLY, THE PATIENT DEVELOPED DYSPHOTOPSIA AND THEY PLANNED TO EXPLANT THE LENS ON (B)(6) 2019. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8469315 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZKB00 +18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 INTO THE PATIENT'S LEFT EYE AND EXPLANTED ON (B)(6) 2019 BECAUSE OF GLARE AND DECREASED VISION. REPORTEDLY, A VITRECTOMY WAS PERFORMED, BUT NO INCISION ENLARGEMENT AND NO OTHER INJURIES OCCURRED. AN AR40E +17.5 DIOPTER WAS IMPLANTED AS A REPLACEMENT. AFTER THE LENS EXCHANGE, THE PATIENT WAS REPORTED BEING HAPPY AND THE SYMPTOMS HAVE RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment; Vitrectomy

  MAUDE report 8353242 ↗
• MalfunctionJan 2, 2019Break; Break

  IT WAS REPORTED THAT THE HAPTIC OF A ZKB00 18.0 DIOPTER LENS WAS BROKEN. THERE WAS CONTACT BETWEEN THE LENS AND THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210948 ↗
• InjuryOct 5, 2018Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +18.0 DIOPTER) WAS INSERTED INTO THE PATIENT'S LEFT EYE, A SCRATCH WAS NOTICED ON THE LENS. REPORTEDLY, THE INCISION WAS ENLARGED TO REMOVE THE LENS AND ANOTHER ZXK00 +18.0 DIOPTER LENS WAS IMPLANTED AS A REPLACEMENT DURING THE SAME SURGICAL PROCEDURE. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED, NO ADVERSE EFFECTS. THE ACCOUNT COMMENTED THAT THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7937508 ↗
• InjurySep 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 18.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. REPORTEDLY, THE PATIENT IS DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7911121 ↗
• InjuryFeb 16, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZKB00 18.0 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 UNSPECIFIED MECHANICAL COMPLICATIONS. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY PERFORMED. THE REPLACEMENT LENS WAS A ZCB00 18.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT''S POST-OPERATIVE DISTANCE VISION IS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7279128 ↗
• InjuryFeb 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZKB00 18.0 INTRAOCULAR LENS (IOL), THE PATIENT WAS NOT SATISFIED WITH THE SURGERY OUTCOME. THE LENS WAS EXCHANGED WITH A ZCB00 18.5 DIOPTER IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6342640 ↗
• InjuryJan 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 18.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT COMPLAINT THAT THEY COULD SEE "FOLD". THE PATIENT IS REPORTED AS FINE AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6262821 ↗