TECNIS IOL ZCT225 (REF ZCT225U080)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474552494), received between Mar 23, 2017 and Mar 31, 2017 — 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.

• MalfunctionMar 31, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZCT225 8.0 DIOPTER INTRAOCULAR LENS (IOL), THE LENS HAD ROTATED 10 DEGREES. THE INITIAL AXIS OF IMPLANTATION WAS 97 DEGREES. AT THE ONE MONTH POST OP VISIT, THE AXIS WAS MEASURED AT 87 DEGREES. THE PATIENT DID NOT REPORT ANY ISSUES. THE LENS REMAINS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6451377 ↗
• MalfunctionMar 23, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) MALE PATIENT. THE IOL, INITIALLY PLACED AT 97 DEGREES, WAS MEASURED AT SIX-MONTH POST-OPERATION VISIT AT 85 DEGREES, WITH A DIFFERENCE OF 12 DEGREES. REPORTEDLY, THE PATIENT HAD NO COMPLAINTS AT THE SIX-MONTH VISIT AND DID NOT REQUIRE A SECONDARY SURGICAL PROCEDURE. THE LENS REMAINED IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED AN IT WAS LEARNT THAT THE SAME IMPLANTED LENS WAS PREVIOUSLY MEASURED AT ONE-MONTH POST-OPERATION VISIT AT 87 DEGREES. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6426841 ↗