TECNIS IOL ZCT400 (REF ZCT400U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474554009), received between Mar 22, 2019 and May 21, 2020 — classified as 2 injuries.

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.

• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LENS WAS EXPLANTED IN SECONDARY SURGICAL PROCEDURE FROM PATIENT¿S RIGHT EYE BECAUSE THE PATIENT DID NOT NEED/WANT THE TORIC CORRECTION AND WAS EXPERIENCING BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT REQUIRED. ANOTHER LENS, DIFFERENT MODEL ZCB00 AND LOWER DIOPTER 20.0 WAS USED AS REPLACEMENT LENS FOR THE PATIENT. NO OTHER SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10077707 ↗
• InjuryMar 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RESIDUAL ASTIGMATISM AFTER THE IMPLANTATION OF LENS MODEL, ZCT400 TORIC IOL (INTRAOCULAR LENS). AS A RESULT, LENS WAS EXPLANTED AND REPLACED WITH LENS MODEL, ZCT300. NO COMPLICATIONS WERE REPORTED TO DATE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446501 ↗