TECNIS IOL ZXR00 (REF ZXR00U0105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474591653), received between Jun 12, 2017 and May 10, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Mechanical Problem” (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.

• InjuryMay 10, 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 PATIENT UNABLE TO ADAPT TO THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. THE SUSPECT LENS WAS REPLACED WITH ANOTHER JOHNSON AND JOHNSON IOL OF DIFFERENT MODEL, BUT THE SAME DIOPTER SIZE (DIB00 +10.5) AS THE ORIGINAL LENS. IT WAS INDICATED THAT THE PATIENT HAS FULLY RECOVERED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Discomfort

  MAUDE report 16908764 ↗
• InjuryNov 21, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A ZXR00 10.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A MECHANICAL FAILURE. THERE WAS AN INCISION ENLARGEMENT MADE, BUT NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8097815 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXR00 10.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED DUE TO UNKNOWN REASONS AND REPLACED WITH MODEL ZCB00. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7012478 ↗
• MalfunctionJun 12, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS SCRATCHED WHEN INSERTING IT INTO THE EYE. THE IOL WAS REMOVED FROM THE EYE WITHOUT AN INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6635471 ↗