TECNIS IOL ZCT400 (REF ZCT400U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474553897), received between Feb 15, 2017 and Aug 23, 2019 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2019Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) 19.0 DIOPTER WAS REMOVED DUE TO REFRACTION BEING OFF. THIS WAS REPLACED WITH A ZCT400, 14.0 DIOPTER POWER. FOLLOW-UP CONFIRMED THAT THE PATIENT IS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8926603 ↗
• MalfunctionMar 8, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) MALE PATIENT ON (B)(6) 2017. THERE WERE NO PATIENT COMPLICATION AND/OR RELATED INJURY. THE LENS ORIGINALLY PLACED AT 86 DEGREES, WAS MEASURED AT 75 DEGREES ON (B)(6) 2018. REPORTEDLY, THERE ARE NO PLANS FOR IOL REPOSITIONING. THE LENS REMAINS IMPLANTED IN THE EYE. THE PATIENT WAS REPORTED DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7326076 ↗
• InjuryMar 16, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT400 19.0 DIOPTER INTRAOCULAR LENS (IOL) ROTATED AFTER IMPLANTATION. REPORTEDLY, THE PHYSICIAN WAS PLANNING ON KEEPING THE LENS IN THE PATIENT'S EYE AND REPOSITIONING THE LENS IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS ROTATED BY 39 DEGREES. THE LENS WAS ROTATED ON (B)(6) 2017. THERE WAS NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6412013 ↗
• MalfunctionFeb 15, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON SLIT LAMP MEASUREMENT, THE INTRAOCULAR LENS (IOL) WAS 100 DEGREES ON (B)(6) 2017, VERSUS THE INTENDED OPERATIVE PLACEMENT OF 90 DEGREES ON (B)(6) 2016. THE EVENT WAS NOT REPORTED AS A PATIENT OR DOCTOR COMPLAINT. THE PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/20 ON HIS RIGHT EYE (OD) ON (B)(6) 2017. THE LENS REMAINS IMPLANTED. PATIENT IS DOING WELL. THE OUTCOME DOES NOT SIGNIFICANTLY INTERFERE WITH ACTIVITIES OF DAILY LIFE. PATIENT WAS HAPPY AND SEEING WELL. THE SURGEON DID NOT FEEL IT WAS A PROBLEM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6334816 ↗