TECNIS IOL ZKB00 (REF ZKB00U0185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 05050474560055), received between Sep 27, 2016 and Apr 25, 2024 — classified as 8 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE JOHNSON AND JOHNSON (JNJ) INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE. THE PATIENT COMPLAINED OF BLURRY VISION. THE ONSET DATE IS UNKNOWN. THE EXPLANTED LENS WAS REPLACED WITH ANOTHER JNJ IOL MODEL ZKU225 18.0 DIOPTER TORIC II MULTIFOCAL LENS. THERE WERE NO PATIENT INJURIES SUCH AS A CAPSULE TEAR, INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. NO PRESCRIBED MEDICATIONS TO PREVENT PERMANENT IMPAIRMENT. THE PATIENT¿S OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 19188572 ↗
• InjuryAug 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POWER REFRACTION WAS OFF, THEREFORE, THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT HIGHER DIOPTER. THERE WAS NO INCISION ENLARGEMENT OR ANY OTHER PATIENT INJURY. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8926929 ↗
• InjuryMay 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) OPERATIVE EYE ON (B)(6) 2015. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO VISUAL DISTURBANCE TO INCLUDE SHIMMERING, RINGS, AND DECREASED QUALITY OF VISION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURE REQUIRED. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances; Visual Impairment

  MAUDE report 8601931 ↗
• MalfunctionNov 9, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  REPORTEDLY, A MARK OR FOREIGN OBJECT WAS SEEN ON A ZKB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) OPTIC UNDER THE MICROSCOPE PRIOR TO INSERTION. THERE WAS NO PATIENT CONTACT WITH THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8056361 ↗
• InjuryFeb 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL), 18.5 DIOPTER WAS EXPLANTED FROM THE RIGHT EYE (OD) OF A FEMALE PATIENT DUE TO CONSTANT FLICKERS OF LIGHT IN THE EYE. THE PATIENT COMPLAINED OF HAVING TROUBLE WITH BALANCE AND NAUSEA AND HAD BLURRY VISION IN THE RIGHT EYE AFTER CATARACT SURGERY. THE PATIENT REPORTS OF DECREASE IN FLICKERS WHEN SHE WEARS SUNGLASSES OR WHEN IS IN A DARK ROOM. A NON-AMO LENS WAS USED AS THE REPLACEMENT LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED AT EXPLANT. THERE WAS NO PATIENT POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Dizziness; Nausea; No Code Available

  MAUDE report 7281535 ↗
• MalfunctionAug 25, 2017Difficult to Fold, Unfold or Collapse; Difficult to Fold, Unfold or Collapse

  WHEN INSERTING THE INTRAOCULAR LENS (IOL) INTO THE EYE, THE CUSTOMER ACCOUNT REPORTED AN IOL UNFOLDING ISSUE. THERE WAS PATIENT CONTACT. REMOVAL OF THE IOL WAS REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information

  MAUDE report 6819681 ↗
• InjuryAug 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6790376 ↗
• MalfunctionJun 19, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AFTER THE INTRAOCULAR LENS (IOL) WAS IMPLANTED, THE DOCTOR NOTICED A SCRATCH ON THE IOL. THE IOL WAS REMOVED BY CUTTING IT INTO PIECES AND A NEW IOL OF THE SAME MODEL AND DIOPTER WAS IMPLANTED. THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6652030 ↗
• InjuryApr 18, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT A ZKB00 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS INSERTED AND REMOVED FROM THE PATIENT¿S EYE DUE TO A TEAR AT THE ELBOW OF THE TRAILING HAPTIC. THE LENS WAS CUT OUT AND AN INCISION ENLARGEMENT WAS REQUIRED. THE PATIENT IS NOTED AS DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6502218 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT EXPERIENCED DYSPHOTOPSIA, HALOS AND GLARE, AFTER IMPLANTATION OF A MULTIFOCAL ZKB00 INTRAOCULAR LENS (IOL) IN HER RIGHT EYE. REPORTEDLY, THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND THE PATIENT WAS REPORTED AS FINE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE INCISION WAS NOT ENLARGED, NO VITRECTOMY WAS PERFORMED AND NO PATIENT POST-OP INJURY WAS REPORTED. THE LENS WAS REPLACED WITH A MONOFOCAL ZCB00 LENS, DIOPTER UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6434379 ↗
• InjurySep 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS WAS EXPLANTED DUE TO A REFRACTIVE ERROR. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 22.5 DIOPTER. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. PATIENT IS CURRENTLY DOING WELL.

  Patient problems: No Code Available

  MAUDE report 5982199 ↗