TECNIS IOL ZXR00 (REF ZXR00U0280)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474579255), received between Jan 3, 2018 and Apr 12, 2022 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 12, 2022Adverse 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 LEFT EYE DUE TO PATIENT NOT GETTING THE READING ABILITY. ANOTHER JOHNSON AND JOHNSON LENS OF DIFFERENT MODEL AND DIOPTER (DFR00V, 27.50 D) WAS USED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. THE PATIENT NOW SEES 20/20 UNCORRECTED AND ABLE TO READ AGAIN WITHOUT CORRECTION. NO PRODUCT WILL BE RETURNED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 14080413 ↗
• InjuryJun 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DOCTOR REPORTED OF CONSIDERING AN EXPLANT IN THREE (3) MONTHS OF A ZXR00 28.0 DIOPTER INTRAOCULAR LENS (IOL) DUE TO THE SYMPTOMS THAT THE PATIENT IS EXPERIENCING. THE SYMPTOMS ARE FLICKERING WITH OVERHEAD FLUORESCENTS AND DAYLIGHT WHICH IS MAKING DRIVING AND DISTANCE VIEWING DIFFICULT FOR THE PATIENT. REPORTEDLY, THE PATIENT DOES NOT HAVE ANY CONTRIBUTING MEDICAL HISTORY AND NO MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED. THERE WAS NO PATIENT INJURY AND NO COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO PATIENT'S RIGHT EYE (OD). A SEPARATE MDR REPORT IS BEING SUBMITTED FOR THE PATIENT'S LEFT EYE (OS).

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7635688 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 28.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO THE PATIENT EXPERIENCING VISION PROBLEMS. THERE WAS NO VITRECTOMY REQUIRED. THE REPLACEMENT LENS WAS A NON-AMO LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7162670 ↗