TECNIS IOL ZCT400 (REF ZCT400U140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553798), received between Jun 13, 2017 and Aug 5, 2019 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) WAS INVOLVED IN A CLINICAL STUDY. AT IMPLANT IOL WAS 167 DEGREES AND DURING THE 6 MONTH VISIT IT WAS NOTED THAT IOL ROTATED TO 156 DEGREES. THERE WAS NO REPOSITIONING PLANNED. NO OTHER SURGICAL ACTION IS PLANNED. THERE WAS NO PATIENT COMPLICATION AND/OR RELATED INJURY. IT WAS STATED THAT THE PATIENT HAS RECOVERED. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8860477 ↗
• MalfunctionJun 13, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) FEMALE PATIENT. THE IOL, INITIALLY PLACED AT 93 DEGREES, WAS MEASURED AT THE SIX-MONTH POST-OPERATION VISIT AT 77 DEGREES. THE LENS HAD ROTATED 16 DEGREES. REPORTEDLY, THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH THE PATIENT'S ACTIVITIES OF DAILY LIFE AND NO FURTHER ACTION WAS TAKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6639161 ↗