TECNIS IOL ZCT150 (REF ZCT150U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474552197), received between Nov 8, 2016 and Mar 31, 2021 — classified as 8 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED BECAUSE IT MALFUNCTIONED. THE REPLACEMENT IOL IS MODEL ZCB00 AND THE SAME DIOPTER. NO DETAILS REGARDING THE TYPE OF MALFUNCTION WERE PROVIDED. THE CUSTOMER SUBSEQUENTLY CLARIFIED THAT THERE WAS NO INCISION ENLARGEMENT, SUTURES OR MEDICAL INTERVENTION. THE PATIENT¿S DAILY ACTIVITIES ARE NOT AFFECTED. REPORTEDLY, THE SYMPTOMS MANIFESTED FROM DAY ONE OF THE IMPLANT AND THE PATIENT OUTCOME IS REPORTED AS UNKNOWN. PRODUCT FOR THIS RETURN IS NOT COMING BACK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 11599640 ↗
• InjurySep 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO RESIDUAL HYPEROPIC ASTIGMATISM. THE LENS WAS REPLACED WITH A MODEL ZCT225 23.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES PERFORMED. THE SUSPECT PRODUCT WILL NOT BE RETURNED, AND THE PATIENT NO LONGER HAS VISUAL ACUITY PROBLEMS POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 10519132 ↗
• InjuryJul 3, 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 DUE TO THE PATIENT EXPERIENCING ISSUES WITH HALOS AND GLARE. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY USING A NON-JOHNSON & JOHNSON AS THE REPLACEMENT LENS. PATIENT OUTCOME WAS NOTED AS THE PATIENT IS DOING WELL, NO LONGER SEES GLARES, AND 20/20 VISION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8756614 ↗
• InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 22.5 DIOPTER LENS WAS IMPLANTED INTO THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO AN UNEXPECTED POST-OPERATIVE REFRACTION (DISTANCE VISION 20/50). THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. THE REPLACEMENT LENS WAS ZCB00 21.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7453085 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNABLE TO TOLERATE THE TORIC INTRAOCULAR LENS AND THE LENS WAS EXPLANTED. A SUTURE AND INCISION ENLARGEMENT WERE REQUIRED, BUT NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7301524 ↗
• InjuryJan 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT150 22.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT EXPERIENCED DISTORTED VISION, A FEELING THAT SOMETHING WAS IN HER EYE, FEELING OFF-BALANCED, PAIN WHERE THE DOCTOR PUT AN EXTRA SUTURE/INCISION, AND HER DEPTH PERCEPTION WAS OFF. THE PATIENT ALSO REPORTED THAT SHE'S SEEING WELL EVEN THOUGH SHE REMAINS ASTIGMATIC EVEN AFTER THE SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Visual Disturbances; Visual Impairment

  MAUDE report 7159042 ↗
• InjuryJul 5, 2017Use of Device Problem; Torn Material; Device Handling Problem; Use of Device Problem; Torn Material; Device Handling Problem

  IT WAS REPORTED THAT DURING SURGERY, AN INTRAOCULAR LENS (IOL) WAS INSERTED INTO THE EYE BUT IT HAD TO BE REMOVED BECAUSE IT TORE. ADDITIONAL INFORMATION WAS RECEIVED AND THE CUSTOMER COMMENTED THAT THE EVENT WAS RELATED TO A LOADING TECHNIQUE. ADDITIONALLY IT WAS REPORTED THAT A NON VALIDATED, NON AMO CARTRIDGE WAS USED IN CONJUNCTION WITH THE LENS. THE INCISION WAS ENLARGED AND SUTURES WERE USED. NO VITRECTOMY WAS PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6688639 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT PRESENTED WITH TOXIC ANTERIOR SEGMENT SYNDROME (TASS) AND MILD LIMBAL EDEMA AFTER IMPLANTATION OF A ZCT150 22.5 DIOPTER INTRAOCULAR LENS INTO THE LEFT EYE. THE LENS REMAINS IMPLANTED. THE MILD PRESENTATION OF TASS HAS RESOLVED AND PATIENT'S VISUAL ACUITY ON THE LEFT EYE IS 20/20. THE PATIENT'S CURRENT STATUS IS INDICATED AS RECOVERED.

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

  MAUDE report 6084719 ↗