TECNIS IOL ZCT150 (REF ZCT150U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552081), received between Nov 8, 2016 and Feb 13, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE(OS)OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO PATIENT BEING UNHAPPY AND SEEING BLURRY. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 14.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING BETTER POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7268459 ↗
• MalfunctionOct 23, 2017Pitted; Pitted

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS LOOSE INSIDE THE CASE IT CAME IN. THE USER NOTICED THE IOL WAS DAMAGED OR PITTED. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Information

  MAUDE report 6970630 ↗
• InjuryAug 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A REFRACTIVE SURPRISE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6756227 ↗
• InjuryJun 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 17.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE DUE TO A RESIDUAL REFRACTIVE ERROR. THE LENS WAS REPLACED WITH A Z9002 WITH A HIGHER DIOPTER SIZE. THE PROCEDURE WENT WELL WITH NO COMPLICATION, NO INJURY AND NO ADDITIONAL PROCEDURES. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6681200 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT HAD A MILD PRESENTATION OF TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AFTER IMPLANTATION OF A MODEL ZCT150 17.0 DIOPTER INTRAOCULAR LENS (IOL) INTO THE LEFT EYE. INFLAMMATION 1ST DAY POST OPERATIVELY WAS NOTED. THE IOL REMAINS IMPLANTED AND THE TASS WAS STATED TO HAVE RESOLVED. VISUAL ACUITY IN THE LEFT EYE IS 20/30 UNCORRECTED. THE PATIENT'S CURRENT STATUS IS INDICATED AS RECOVERED.

  Patient problems: Inflammation; No Code Available; Pain; Red Eye(s)

  MAUDE report 6087362 ↗