TECNIS IOL ZCT400 (REF ZCT400U135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553781), received between Sep 1, 2017 and Jul 11, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 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 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.

• InjuryJul 11, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN THE RIGHT EYE (OD) ROTATED COUNTER CLOCKWISE BY 30 DEGREES. THE DOCTOR REPOSITIONED THE LENS ABOUT A WEEK AFTER IMPLANT. VISUAL ISSUE BEFORE REPOSITIONING WAS BLURRY WHICH FIRST OCCURRED ON DAY ONE POST-OP. VISUAL ACUITY (VA) THEN WAS 20/200 AS LENS ROTATED. THE PATIENT WAS WELL POST-OP. PATIENT AND DOCTOR IDENTIFIERS WERE PROVIDED. NO OTHER ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8783430 ↗
• InjuryDec 13, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 13.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT COMPLAINED OF BLURRY VISION AND WAS NEVER HAPPY WITH HIS VISION SINCE SURGERY. ALSO, POST-OPERATIVELY ON (B)(6) 2018, THE PATIENT'S LENS ROTATED 23 DEGREES. WHEN PRESENTED WITH THE OPTION TO EXCHANGE FOR A DIFFERENT POWER TORIC LENS, THE PATIENT CHOSE TO EXPLANT THE CURRENT LENS AND REPLACE WITH A NON-TORIC LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A PCB00 14.5 DIOPTER LENS. REPORTEDLY, THE PATIENT HAD A GOOD OUTCOME POST EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8158682 ↗
• InjuryJul 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A ZCT400 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S EYE DUE TO VISUAL DISTURBANCE. THERE WAS NO VITRECTOMY, NO SUTURES, AND NO INCISION ENLARGEMENT REQUIRED. PATIENT HAS RECOVERED; NO COMPLICATIONS WERE REPORTED POST-SURGERY. THE LENS WAS REPLACED WITH THE SAME MODEL, A LARGER, 15.0 DIOPTER LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7676346 ↗
• InjurySep 1, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO AN INCORRECT POWER WAS SELECTED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT A DIFFERENT DIOPTER (16.0). IT WAS REPORTED THAT THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6840483 ↗