TECNIS IOL ZCT150 (REF ZCT150U130)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474552005), received between Nov 28, 2017 and Oct 22, 2019 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryOct 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED. REQUESTS FOR ADDITIONAL INFORMATION HAVE BEEN MADE BUT NO RESPONSE HAS BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available; No Patient Involvement

  MAUDE report 9221759 ↗
• InjuryNov 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 13.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017 ALONGSIDE A SECONDARY SURGERY (BLEB FOR GLAUCOMA). IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT'S ASTIGMATISM INCREASED, WHICH REPORTEDLY WAS POSSIBLY DUE TO THE SECONDARY SURGERY. FURTHERMORE, THE EXPLANT WAS PERFORMED TO BRING THE PATIENT'S VISION BACK TO PRE-OPERATIVE CORNEAL ASTIGMATISM. THERE WAS NO INCISION ENLARGEMENT, BUT A VITRECTOMY WAS PERFORMED BECAUSE ONE HALF OF THE LENS THAT WAS CUT IN HALF TO EXPLANT, TORE THE CAPSULAR BAG. TWO SUTURES WERE ALSO USED. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. THE LENS WAS REPLACED WITH A NON-AMO LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 7065998 ↗