TECNIS IOL ZCT150 (REF ZCT150U115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474551978), received between May 24, 2017 and Jul 7, 2021 — classified as 5 injuries.

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

• InjuryJul 7, 2021Unstable; Unstable

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE OF A PATIENT IN A SECONDARY SURGICAL PROCEDURE DUE TO IOL SLIDE/ROTATION AND DOUBLE VISION. A REPLACEMENT LENS OF MODEL ZCU150, 13.0 DIOPTER WAS USED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 12131977 ↗
• InjuryMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LENS MODEL, ZCT150 TORIC IOL (INTRAOCULAR LENS) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO AN UNSPECIFIED VISUAL ISSUE. THE REPLACEMENT LENS WAS THE SAME MODEL BUT HIGHER DIOPTER (15.5). PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8435194 ↗
• InjuryApr 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 11.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 AND REPLACED WITH A ZCT300 11.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7446486 ↗
• InjuryJul 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS MODEL ZCT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S EYE BECAUSE SHE DECIDED SHE WANTED A SYMFONY LENS. NOTHING WAS WRONG WITH THE ZCT150 LENS. A ZXT150 11.0 DIOPTER IOL WAS IMPLANTED AND THE PATIENT IS DOING FINE.

  Patient problems: No Code Available

  MAUDE report 6699520 ↗
• InjuryMay 24, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT150 11.5 DIOPTER IOL WAS EXPLANTED AS IT WAS DISCOVERED THAT THE PATIENT REQUIRED A HIGHER DIOPTER LENS BECAUSE THEIR VISUAL OUTCOME WAS NOT STRONG ENOUGH. THE LENS WAS REPLACED WITH THE SAME MODEL IOL WITH A HIGHER DIOPTER. THERE WAS NO PATIENT INJURY SUCH AS INCISION ENLARGEMENT, CAPSULE TEAR, OR VITRECTOMY REPORTED. PATIENT IS DOING FINE, NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6586831 ↗