TECNIS IOL ZCT225 (REF ZCT225U105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474552548), received between May 11, 2017 and Feb 11, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS FULLY INSERTED INTO PATIENT'S RIGHT EYE, HOWEVER, WAS THE LENS WAS REMOVED DURING THE SAME PROCEDURE AS THE SURGEON NOTICED A V-SHAPED DEFECT AT THE CENTER OF THE LENS .ANOTHER JOHNSON & JOHNSON LENS OF SAME MODEL AND DIOPTER WAS USED AS THE REPLACEMENT. THERE WAS NO PATIENT INJURY AND NO OTHER SURGICAL INTERVENTION WAS REQUIRED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13518991 ↗
• InjuryMay 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 10.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO A RESIDUAL REFRACTIVE ERROR. THE LENS WAS REPLACED WITH A ZCT300 10.0 DIOPTER IOL. THERE WAS NO COMPLICATIONS AND NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6562330 ↗