TECNIS IOL ZKB00 (REF ZKB00U0235)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 05050474560154), received between Sep 14, 2016 and Aug 20, 2025 — classified as 10 injuries, 3 malfunctions.

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED BECAUSE THE PATIENT WAS UNHAPPY WITH VISION AND REPORTEDLY HAD UNREALISTIC EXPECTATIONS. THE EXPLANT WAS PERFORMED IN A SECONDARY PROCEDURE, AND THE LENS WAS REPLACED WITH A MONOFOCAL ALCON LENS. NO INJURY OR FURTHER INTERVENTION WAS REQUIRED. THE POSTOPERATIVE OUTCOME IS 20/20. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Discomfort

  MAUDE report 22853695 ↗
• MalfunctionNov 5, 2024Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem; Delivered as Unsterile Product; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE SHIPPING BOX OF THE NON-PRELOADED INTRAOCULAR LENS(IOL) WAS DAMAGED. FROM ADDITIONAL INFORMATION IT WAS LEARNT THAT SHIPPING BOX WAS INTACT. THE STICKER THAT SEALS THE END IS HALFWAY TORN AND THE BOX IS PRETTY CRUSHED AND COULD HAVE DAMAGED THE PRODUCT ON THE INSIDE AND THERE WAS A POTENTIAL BREACH. COULD HAVE DAMAGED THE PRODUCT ON THE INSIDE. NO OTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20606299 ↗
• InjuryJul 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS MYOPIC SURPRISE POST IMPLANTATION OF THE INTRAOCULAR LENS (IOL). IT WAS STATED THAT PATIENT WAS UNABLE TO SEE CLEARLY AT ANY RANGE AND THEIR DAILY ACTIVITIES WERE SIGNIFICANTLY AFFECTED. THEREFORE, THE LENS WAS EXPLANTED/EXCHANGED. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES WERE REQUIRED. NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12257027 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO BLURRED VISION. THERE WAS NO PATIENT INJURY. THE REPLACEMENT LENS USED IS OF SAME MODEL. PATIENT WAS DOING FINE. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12132480 ↗
• InjuryJun 2, 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 HIS RIGHT EYE (OD) DUE TO DYSPHOTOPSIA. THERE WERE NO MEDICAL OR SURGICAL INTERVENTION REQUIRED SUCH AS VITRECTOMY, SUTURES OR INCISION ENLARGEMENT. THERE WAS NO PATIENT INJURY REPORTED. A REPLACEMENT JNJ INTRAOCULAR LENS DIFFERENT MODEL WAS IMPLANTED. THE PATIENT IS DOING FINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11921462 ↗
• MalfunctionApr 30, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENT WAS RELATED TO LENS DAMAGE. THERE WAS NO PATIENT INJURY REPORTED ASSOCIATED TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8563577 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT +23.5 DIOPTER LENS MODEL, ZKB00 MULTIFOCAL IOL (INTRAOCULAR LENS) WAS EXPLANTED DUE TO BLURRY VISION WITH GLARE. AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH +25.0 DIOPTER LENS MODEL ZCB00, A MONOFOCAL IOL. THERE WAS NO PATIENT COMPLICATION REPORTED AFTER REPLACEMENT. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8453815 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT SHE HAD THE CATARACT SURGERY AND WAS IMPLANTED WITH THE TECNIS MULTIFOCAL INTRAOCULAR LENSES IN BOTH EYES (OU). THE PATIENT COMPLAINED OF HAVING VISUAL DISTURBANCE AND IMPAIRED VISION THAT REQUIRES BI-FOCAL GLASSES. THE ISSUE OF HAZING AND WORSE VISION WAS REPORTED IMMEDIATELY AND SHE WAS TOLD THAT SHE COULD WEAR READING GLASSES UNTIL AN ADDITIONAL EASY FIX WAS MADE WITH THE ADDITION OF LASER SURGERY. THE RIGHT EYE IMPLANT WAS PERFORMED ON (B)(6) 2017, THE SECOND EYE WAS IMPLANTED TWO WEEKS LATER. THE IMPLANTS ARE STILL IN PLACE. THE PATIENT REPORTED THAT AFTER RECEIVING HER LENSES, SHE COULD NOT DRIVE ANY FURTHER THAN ONE MILE WITHOUT FEAR OF EXPERIENCING AN UNCONTROLLABLE IMPULSE TO SHUT HER EYES. ADDITIONALLY, SHE REPORTED ANY BRIGHT LIGHT, SUNSHINE OR EVEN HOME LIGHTING OR ANY ATMOSPHERIC CHANGE WOULD BOTHER HER. SOME DAYS SHE KNEW SHE COULD NOT DRIVE, DEPENDED ON SOMEONE ELSE TO DRIVE HER, AND WORE DARK GLASSES PROVIDED BY THE SURGEON. THE PATIENT WAS ADVISED TO USE EYE LID SCRUBS, REFRESH DROPS AND WAS GIVEN A PRESCRIPTION OF RESTASIS, ALL OF WHICH REPORTEDLY DID NOT HELP HER. A LASER PROCEDURE WAS PERFORMED, PATIENT REPORTEDLY STILL EXPERIENCING VARIO

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 7706139 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 23.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED BECAUSE THE PATIENT COMPLAINED OF HALOS. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. REPORTEDLY, THE PATIENT IS OKAY AND THE LENS WAS REPLACED WITH A NON-AMO LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7255674 ↗
• InjuryDec 27, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT TECNIS MULTIFOCAL INTRAOCULAR LENS (MODEL ZKB00, +23.5 DIOPTER) WAS EXPLANTED IN SECONDARY SURGERY BECAUSE OF THE PATIENT COMPLAINING OF BLURRY VISION. THE LENS WAS REPLACED WITH THE SAME MODEL LENS, A LARGER, 24.5 DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDE.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7148975 ↗
• MalfunctionMay 2, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WAS A SCRATCH ON THE INTRAOCULAR LENS (IOL) UPON OPENING THE PACKAGE. THERE WAS NO PATIENT CONTACT. THE IOL WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Patient Involvement

  MAUDE report 6536045 ↗
• InjuryJan 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT REPORTED THAT A ZKB00 INTRAOCULAR LENS WAS EXPLANTED DUE TO PATIENT EXPERIENCING HALOS AFTER SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6236084 ↗
• InjurySep 14, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WILL BE EXPLANTED SOON DUE TO THE PATIENT "JUST HAS DIFFERENT VISION DEMANDS." NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 5951192 ↗