TECNIS IOL ZCT450 (REF ZCT450U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474602960), received between Nov 9, 2016 and Oct 12, 2019 — classified as 2 injuries, 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED THAT HE HAS A PATIENT WHO WAS A -10 AND NEEDED CATARACT SURGERY AND ALSO HAD 4 DIOPTERS OF CYLINDER (ASTIGMATISM). THE DOCTOR IMPLANTED A ZCT450 19.0 DIOPTER INTRAOCULAR LENS (IOL) ON (B)(6) 2019. PATIENT ENDED UP WITH A REFRACTION OF -10.0 X 4.75 AT 85 DEGREES. THE PATIENT IS STILL VERY MINUS AND HAS SIGNIFICANT RESIDUAL CYLINDER. THE LENS WAS EXPLANTED ON (B)(6) 2019. THE PATIENT HAS RECOVERED AND NO COMPLICATIONS WERE REPORTED POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9183164 ↗
• MalfunctionSep 27, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT MODEL ZCT450 TECNIS TORIC IOL (INTRAOCULAR LENS) WAS PLACED AT 160 DEGREES IN THE PATIENT'S LEFT EYE (OS) AND WAS MEASURED AT 170 DEGREES IN THE 1-MONTH STUDY VISIT. THIS OUTCOME DID NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. THERE WAS NO PATIENT INJURY. NO INTERVENTION HAS BEEN PLANNED OR PERFORMED AND THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7916894 ↗
• InjuryNov 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT450 19.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE LEFT EYE OF A FEMALE PATIENT DUE TO A HYPEROPIC SURPRISE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY POST-OP. THE LENS WAS REPLACED WITH A MODEL ZCT400 21.0 DIOPTER LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6088293 ↗