TECNIS IOL ZCT400 (REF ZCT400U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553842), received between Aug 30, 2017 and Jul 26, 2018 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (3 reports).

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.

• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT400 +16.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO RESIDUAL CYLINDER. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL OF A ZCT300. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7721756 ↗
• MalfunctionJun 22, 2018Unintended Movement; Unintended Movement

  REPORTEDLY, THE SUBJECT'S RIGHT EYE (OD) ZCT400 INTRAOCULAR LENS (IOL) WAS 30 DEGREES AT SURGERY (B)(6) 2018, BUT NOTED TO BE AT 19 DEGREES AT THE 1-MONTH VISIT ON (B)(6) 2018 (11 DEGREE ROTATION). THE SUBJECT IS DOING WELL. NO VISUAL COMPLAINTS AND NO ADDITIONAL REPOSITIONING ARE PLANNED AT THIS TIME. UNCORRECTED VISUAL ACUITY (VA) WAS 20/25 OU. AND BEST-CORRECTED VA RESULTS WERE 20/15 OD, 20/20 OS AND 20/15 FOR BOTH EYES (OU). THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAIN TO RIGHT EYE (OD). A SEPARATE REPORT HAS BEEN SUBMITTED TO LEFT EYE (OS).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7629501 ↗
• InjurySep 28, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A PATIENT HAD TO COME BACK THE SAME DAY ((B)(6) 2017) AS THE LENS IMPLANTED, A ZCT400 16.5 DIOPTER INTRAOCULAR LENS (IOL) HAD ROTATED AND HAD TO BE REPOSITIONED IN A SECONDARY PROCEDURE. FURTHERMORE, THE PATIENT HAD TO COME BACK A SEPARATE DAY TO HAVE THE LENS EXPLANTED DUE TO A LARGE EYE. REPORTEDLY, THE PATIENT IS DOING FINE. THE LENS WAS REPLACED WITH A MODEL ZCT300 LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6902373 ↗
• InjuryAug 30, 2017Inadequacy of Device Shape and/or Size; Unintended Movement; Inadequacy of Device Shape and/or Size; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. THE LENS WAS LATER EXPLANTED ON (B)(6) 2017, TO CHANGE THE DIOPTER SIZE AND BECAUSE THE LENS ROTATED. THE LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6833128 ↗