TECNIS IOL ZCT400 (REF ZCT400U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474553835), received between Jul 17, 2018 and Aug 27, 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 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.

• InjuryAug 27, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE IS PLANNED TO BE EXPLANTED SOON AS IT ROTATED 45 DEGREES FROM ITS ORIGINAL POSITION. THE PATIENT HAS BLURRY VISION, UNCORRECTED VISION WAS ABOUT 20/50 POSTOP DAY 1, DROPPED TO 20/200. WITH CORRECTION VISUAL ACUITY IS 20/30. NO OTHER INFORMATION WAS PROVED.

  Patient problems: Blurred Vision; Therapeutic Effects, Unexpected

  MAUDE report 10463676 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT400 INTRAOCULAR LENS (IOL) WAS NOT LOADED PROPERLY AND THAT THE SURGEON HAD TO USE A SUTURE ON THE PRIMARY INCISION FOR CLOSURE SINCE THE RESURE SEALANT DID NOT WORK. REPORTEDLY, THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9233877 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, A MALE PATIENT EXPERIENCED AN UNEXPECTED POST-OP REFRACTION IN HIS LEFT EYE (OS) AFTER IMPLANT OF A MODEL ZCT400 TORIC INTRAOCULAR LENS (IOL). PER ACCOUNT, THERE WAS A REFRACTIVE SURPRISE AND IT WAS DECIDED THAT THE ASTIGMATISM READINGS WERE INCORRECT DUE TO K SCANNING FROM SHINGLES AND THE BEST COURSE OF ACTION WAS TO REMOVE THE TORIC IOL AND REPLACE WITH A NON-TORIC IOL. THE LENS WAS EXPLANTED ON (B)(6) 2018. NO PATIENT INJURY AND NO INCISION ENLARGEMENT WERE REPORTED. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7696394 ↗