TECNIS IOL ZCU225 (REF ZCU225U215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474659001), received between Jun 23, 2020 and Nov 17, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) THAT WAS FULLY INSERTED IN THE PATIENT'S LEFT EYE WAS REMOVED IN THE SAME PROCEDURE DUE TO A TEAR IN THE CAPSULE. THERE WAS NO PATIENT INJURY. A VITRECTOMY, AN INCISION ENLARGEMENT, AND SUTURES WERE REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Capsular Bag Tear

  MAUDE report 12833023 ↗
• MalfunctionDec 21, 2020Unintended Movement; Unintended Movement

  REPORT OF THE STUDY PATIENT'S OPERATIVE VISIT STATED THAT THE ACTUAL INTRAOCULAR LENS (IOL) AXIS PLACEMENT WAS 176 DEGREES FOR THE LEFT EYE (OS). THE PATIENT'S SLIT LAMP AXIS MEASUREMENT OS AT 1 DAY POST-OPERATIVE VISIT WAS RECORDED AS 006 DEGREES. THIS IS A 10 DEGREE ROTATION OF THE IOL AS COMPARED TO THE AXIS PLACEMENT. THE PATIENT'S 1 WEEK OS, POST-OPERATIVE VISIT SLIT LAMP AXIS MEASUREMENT WAS RECORDED AS 006 DEGREES AGAIN. UNCORRECTED VISUAL ACUITY OS AT THE 1-DAY POSTOPERATIVE VISIT: 20/16. SUBJECT REPORTED NO VISUAL SYMPTOMS AT THIS VISIT. NO SURGICAL INTERVENTION IS PLANNED AT THIS TIME. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11049520 ↗
• InjuryJun 23, 2020Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS ROTATED TWICE, THEREFORE, THE PATIENTS EYE HAD SOME SWELLING. THROUGH FOLLOW-UP, IT WAS LEARNED DURING THE INITIAL PROCEDURE, THE SURGEON COULD NOT ALIGN THE DOTS OF THE LENS WHILE IN THE EYE, THEREFORE, THE SURGEON HAD TO ROTATE THE LENS. THE LENS WAS ROTATED AGAIN, BECAUSE THE MANIPULATION OF THE LENS IN THE EYE AFFECTED THE VISUAL ACUITY. THE LENS REMAINS IMPLANTED. THE PATIENT OUTCOME WAS UNKNOWN AS THE SURGEON HAD NOT SEEN THE PATIENT FOR A FOLLOW-UP VISIT YET. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Edema

  MAUDE report 10182912 ↗