TECNIS IOL ZCT400 (REF ZCT400U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553996), received between Jun 28, 2017 and Apr 6, 2020 — classified as 3 injuries.

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 18, 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.

• InjuryApr 6, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT LENS WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING MECHANICAL COMPLICATION, UNPREDICTABLE REFRACTION OUTCOME WITH LENS ROTATION AND BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, NO SUTURES AND NO VITRECTOMY REQUIRED. VISUAL ACUITY PRE-OPERATIVE WAS 20/60 AND VISUAL ACUITY POST-OPERATIVE WAS 20/25. A DIFFERENT MODEL LENS WITH A HIGHER DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS SATISFIED WITH OUTCOME. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9927482 ↗
• InjuryOct 22, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZCT400 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MECHANICAL ISSUES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6967888 ↗
• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHEN INSERTING THE INTRAOCULAR LENS (IOL) INTO THE EYE, THE DOCTOR MADE A HOLE IN THE IOL. THE IOL WAS REMOVED DURING SAME SURGERY. THE DOCTOR HAD TO CUT THE IOL OUT AND MADE SUTURES. THROUGH FOLLOW UP, THE CUSTOMER CONFIRMED THAT THE IOL WAS FULLY INSERTED, THERE WAS NO VITRECTOMY, AND THERE WAS AN INCISION ENLARGEMENT. THERE WAS NO SERIOUS PATIENT INJURY. THE NUMBER OF SUTURES WERE UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER IOL. ADDITIONALLY, THE CUSTOMER STATED THAT THE HOLE WAS NOT IN THE IOL BUT IN THE CAPSULAR BAG. THERE WAS NO SERIOUS PATIENT INJURY AND NO MEDICAL COMPLICATIONS. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 6675766 ↗