TECNIS IOL ZCT400 (REF ZCT400U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553934), received between May 1, 2019 and Mar 19, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 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.

• InjuryMar 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHEN NON PRELOADED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN TO THE PATIENT'S RIGHT EYE THERE WAS DISLOCATION OF THE LENS, THE SYMPTOMS WERE DEBILITATING. THE LENS WAS EXPLANTED IN A SECONDARY PROCEDURE AND REPLACED WITH THE SAME MODEL AND SAME DIOPTER LENS. THERE WAS NO PATIENT INJURY. THERE WERE SUTURES REQUIRED AS A PART OF ROUTINE PRACTICE. THERE WERE NO MEDICATION PRESCRIBED OUTSIDE THE REGULAR STANDARD CARE. NO OTHER INFORMATION IS AVAILABLE.

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

  MAUDE report 18937913 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT'S OPERATIVE EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO REFRACTIVE ERROR AND BURRED VISION. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11317745 ↗
• InjuryOct 1, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE DOCTOR TO HIS JOHNSON & JOHNSON SALES REPRESENTATIVE DURING A CONVERSATION, THAT HE HAD PATIENTS WHO'S INTRAOCULAR LENSES (IOL) HAD ROTATED POST OP. THE LENSES WERE ALL MODEL ZCT LENSES. THE DOCTOR STATED THAT THE ROTATION WAS ABOUT 10-15 DEGREES AND THIS HAPPENED OVER THE COURSE OF THE LAST FEW MONTHS. THE FOLLOWING INFORMATION WAS PROVIDED FOR PATIENT NUMBER 1. THE INTRAOCULAR LENS ROTATED COUNTER CLOCKWISE, THE DEGREE OF ROTATION UNKNOWN, IN THE PATIENT'S LEFT EYE. THE PATIENT WAS TAKEN BACK TO SURGERY, (B)(6) 2019, FOR A REPOSITIONING. THE PATIENT DID WELL POST OP. PATIENT'S VISUAL ACUITY POST OP IMPLANT AND BEFORE REPOSITIONING WAS 20/50 AND 20/25 POST REPOSITIONING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9141702 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCT400 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE DUE TO REFRACTIVE MISS. THE REPLACEMENT LENS WAS THE SAME DIOPTER BUT A DIFFERENT MODEL (ZCT150). NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8571115 ↗