TECNIS IOL ZCT600 (REF ZCT600U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474604209), received between Sep 21, 2018 and Sep 30, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (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. How this data works · Data updated Oct 13, 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.

• InjurySep 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THE PATIENT EXPERIENCED UNEXPECTED POSTOP REFRACTION/NOT OPTIMAL VISION POST-IMPLANT OF AN INTRAOCULAR LENS (IOL). THE IOL WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE INCISION WAS NOT ENLARGED. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE, AND THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10609879 ↗
• MalfunctionSep 21, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT600 22.0 DIOPTER LENS ROTATED 35 DEGREES POST-OPERATIVELY. THE INITIAL IMPLANT DATE WAS (B)(6) 2018 AND THERE WAS NO PATIENT INJURY. REPORTEDLY, THE PATIENT IS FRUSTRATED AND WEARING GLASSES, AS A SECONDARY PROCEDURE TO ROTATE THE LENS WAS NOT PERFORMED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900159 ↗