TECNIS IOL ZKB00 (REF ZKB00U0255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474560192), received between Jan 10, 2017 and Jun 13, 2019 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST IMPLANT OF THE INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, THERE WAS A MYOPIC SHIFT. THE LENS WAS EXCHANGED WITH AN IOL OF THE SAME MODEL BUT LOWER DIOPTER LENS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY AND THERE WAS NO ADDITIONAL INTERVENTION PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8694419 ↗
• InjuryMay 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZKB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE (OD) DUE TO ISSUES WITH GLARE AND VISUAL DISTURBANCE. THROUGH FOLLOW-UP IT WAS LEARNED THE PATIENT FIRST REPORTED BLURRED DISTANCE VISION AND NEAR WHEN READING TWO AND HALF WEEKS AFTER IMPLANTATION. THE LENS WAS SUBSEQUENTLY EXPLANTED REQUIRING THE INCISION TO BE ENLARGED FROM 2.4 MM TO 2.8MM. THE REPLACEMENT LENS WAS THE SAME MODEL BUT A LOWER DIOPTER (23.5). THE EXPLANTED LENS WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. THE PATIENT WAS NOTED TO BE RECOVERED AND THE OUTCOME DOES NOT INTERFERE WITH ACTIVITIES OF DAILY LIFE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 7481997 ↗
• MalfunctionJan 11, 2018Break; Difficult or Delayed Positioning; Positioning Failure; Break; Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT A ZKB00 25.5 DIOPTER INTRAOCULAR LENS (IOL) BECAME STUCK IN AN UNKNOWN CARTRIDGE MODEL UPON INSERTION INTO THE PATIENT'S OPERATIVE EYE, WHICH CAUSED A HAPTIC TO BREAK. REPORTEDLY, THERE WAS NO PATIENT CONTACT; HOWEVER, THIS WAS NOT CONFIRMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7183285 ↗
• InjuryJan 10, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT A ZKB00 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO LENS POOR PERFORMANCE. PATIENT WAS DISSATISFIED WITH THE OUTCOME. THROUGH FOLLOW UP IT WAS LEARNED THAT THE PHYSICIAN HAD PLANNED TO EXPLANT THE LENS IN DECEMBER, HOWEVER THE EXPLANT DID NOT OCCUR UNTIL (B)(6) 2017. THE LENS WAS REPLACED WITH A MONOFOCAL LENS WITHOUT INCIDENT. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY REQUIRED.

  Patient problems: No Code Available

  MAUDE report 6239927 ↗