TECNIS IOL ZKB00 (REF ZKB00U0195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474560079), received between Aug 15, 2017 and Oct 31, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PRELOADED MONOFOCAL IOL HAD BEEN EXPLANTED DUE TO THE PATIENT¿S UNSATISFACTORY WITH THE QUALITY OF VISION, BOTH NEAR AND FAR AS WELL AS CONTINUAL FOGGING, WHICH WERE DEBILITATING SYMPTOMS FOR THE PATIENT. THE IOL WAS REPLACED WITH ANOTHER UNSPECIFIED IOL. THE PATIENT HAS FULLY RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 20583172 ↗
• MalfunctionMar 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE NON-PRELOADED INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO BECOMING DISLOCATED. ANOTHER JOHNSON AND JOHNSON IOL WAS IMPLANTED AS REPLACEMENT (ZMA00, 19.0 DIOPTER). THERE WAS NO PATIENT INJURY. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19001410 ↗
• InjuryJan 18, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO LENS DISLOCATION. ANOTHER JOHNSON & JOHNSON LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (20.5D) WAS USED AS A REPLACEMENT IOL. NO SURGICAL AND/OR MEDICAL INTERVENTIONS REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18540070 ↗
• InjuryAug 22, 2023Adverse 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 RIGHT EYE DUE TO CHANGE FROM MULTIFOCAL IOL TO STANDARD IOL. SUSPECT IOL WAS REPLACED WITH A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO PATIENT POST-OP INJURY. THE PATIENT OUTCOME IS UNKNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 17599589 ↗
• MalfunctionNov 17, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS INSERTED INTO PATIENT'S LEFT EYE, HOWEVER, WAS REMOVED DURING THE SAME PROCEDURE. IT WAS INITIALLY INDICATED THAT THE LENS EXPLANTED ITSELF, HOWEVER, THE SURGEON DENIED IT THROUGH THE ADDITIONAL INFORMATION PROVIDED. HE ALSO MENTIONED THAT THE LENS WAS REMOVED UNEVENTFULLY FROM THE EYE AS IT HAD BENT HAPTIC. ANOTHER LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER MEDICAL/ SURGICAL INTERVENTION WAS REQUIRED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811920 ↗
• InjuryOct 31, 2022Material Opacification; Material Opacification

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE BECAUSE OF OPACIFICATION ON THE LENS. THE PATIENT COULD NOT SEE CLEARLY, AND THEIR VISION WAS BLURRY. THE LENS WAS CUT IN 3 PIECES TO LEAVE CENTRAL ZONE WITH OPACITY INTACT. ANOTHER JOHNSON AND JOHNSON LENS WITH THE SAME MODEL AND DIOPTER IMPLANTED AS A REPLACEMENT. IT WAS CONFIRMED THAT THE PROBLEM WAS NOT A PRE-EXISTING ISSUE, IT WAS NOT POSTERIOR CAPSULAR OPACIFICATION (PCO), AND NO YTTRIUM-ALUMINUM-GARNET (YAG) WAS PERFORMED. THE PATIENT IS DOING FINE POST EXPLANT AND NO INJURY WAS REPORTED, AND THE PATIENT OUTCOME WAS GOOD. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 15705289 ↗
• InjuryFeb 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO PATIENT COMPLAINTS OF HALOS, GLARE, AND HEADACHES. REPORTEDLY, THE PATIENT COMPLAINED OF HALOS IN EVERY OTHER SCENARIO. AT NIGHT, THE PATIENT COMPLAINED OF EXTREME HALOS, WHICH CAUSE SQUINTING WHILE DRIVING. ALSO, UNDER FLUORESCENT LIGHTING, EVERYTHING TOOK ON WHITE HAZE. WHEN THE PATIENT USED THE COMPUTER, THE WHITE BACKGROUND OF THE MONITOR WOULD SWALLOW THE BLACK PRINT. THE PATIENT ALSO EXPERIENCED HEADACHES WHEN WATCHING TELEVISION IN A DARK ROOM. THERE WAS NO INCISION ENLARGEMENT. THE LENS WAS REPLACED WITH THE SAME DIOPTER, BUT DIFFERENT MODEL OF ZCB00, A MONOFOCAL LENS. REPORTEDLY, THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; Headache; No Code Available

  MAUDE report 7265426 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZKB00 19.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. THE PATIENT REPORTED HIS VISION WAS GREAT FOLLOWING THE IMPLANTATION PROCEDURE EVEN THOUGH HE DEVELOPED A MINOR INFECTION WHICH WAS TREATED BY MEDICATION. HOWEVER, THE PATIENT EXPERIENCED VISUAL DIFFICULTIES AFTER A YTTRIUM-ALUMINUM GARNET (YAG) WAS PERFORMED IN (B)(6) OF 2017. THE PATIENT COMPLAINED OF NOT BEING ABLE TO READ UP CLOSE, DISTANCE VISION WAS BLURRY, SEEING HALOS AT NIGHT, DIZZINESS, AND HEADACHES. REPORTEDLY, THE DOCTOR EXPLAINED TO THE PATIENT THESE COMPLAINTS WERE DUE TO DRY EYES, WHICH THE PATIENT HAD TREATED FOR WITH PLUGS PRIOR TO CATARACT SURGERY. THE PATIENT STILL HAS DRY EYES. ALSO, WHEN THE PATIENT ASKED WHY THE YAG PROCEDURE WAS PERFORMED, THE DOCTOR'S REASON WAS BECAUSE IT WAS ROUTINE FOR THEIR OFFICE TO PERFORM THIS PROCEDURE AT A PATIENT'S ONE MONTH POST-OPERATIVE VISIT. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Unspecified Infection; Visual Impairment

  MAUDE report 7163032 ↗
• InjuryAug 15, 2017Adverse 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 A MALE PATIENT'S RIGHT EYE (OD) DUE TO HALOS/GLARE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED AT EXPLANT. THERE WAS NO PATIENT POST-OP INJURY REPORTED. THE REPLACEMENT LENS WAS A MODEL Z9002 LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6794583 ↗