TECNIS IOL ZCT400 (REF ZCT400U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474553828), received between Nov 22, 2017 and Dec 11, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 18, 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.

• InjuryDec 11, 2018Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT400 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018 DUE TO UNEXPECTED POSTOP REFRACTION. THE DOCTOR INDICATED THAT THE DIOPTER POWER MADE THE PATIENT FEEL OFF BALANCE VISUALLY. THERE WAS NO INCISION ENLARGEMENT AND SUTURE USED. THE REPLACEMENT LENS WAS THE SAME MODEL OF A LOWER DIOPTER POWER, 13.0. REPORTEDLY, THE PATIENT IS DOING FINE POST OPERATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8154057 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZCT400, +15.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT HAD DIFFICULTY WITH GLARE. REPORTEDLY, ANOTHER LENS WAS IMPLANTED (MODEL ZCT225, +14.5 DIOPTER) AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7054410 ↗