TECNIS IOL ZCT225 (REF ZCT225U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552685), received between Jul 28, 2017 and Oct 13, 2020 — classified as 5 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. 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.

• InjuryOct 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS RESIDUAL MYOPIA AND ASTIGMATISM POST IMPLANTATION. THE PATIENT ALSO HAS IMBALANCE (ANISOMETROPIA). THE PATIENT COMPLAINED OF HAVING ONGOING DIFFICULTY SEEING POST-OPERATIVELY. VISION IN LEFT EYE WORSE WITH NIGHT DRIVING. VISUAL ACUITY (VA) PRE-OP: WAS NOT PROVIDED. VISUAL ACUITY POST-OP: -1.50 + 1.00. THEREFORE, THE PATIENT WAS SCHEDULED FOR AN INTRAOCULAR LENS (IOL) EXCHANGE. THROUGH FOLLOW-UP, IT WAS LEARNED THE PATIENT HAD A LOSS OF 2 OR MORE LINES BEST SPECTACLE CORRECTED VISUAL ACUITY (BSCVA) OR 2 OR MORE DIOPTERS. THE PATIENT HAS A HISTORY OF ASTIGMATISM. AND THE VA NEGATIVELY IMPACTED THE PATIENT. THEREFORE, THE LENS WAS EXPLANTED FROM THE LEFT EYE. THERE WAS NO INCISION ENLARGEMENT/UNPLANNED SUTURES/VITRECTOMY REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (DIFFERENT MODEL AND LOWER DIOPTER) WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT. THE PATIENT WAS DOING WELL AT DISCHARGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Therapeutic Effects, Unexpected; Visual Disturbances; Visual Impairment

  MAUDE report 10673164 ↗
• InjuryAug 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT225 +17.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S OPERATIVE EYE IN SECONDARY SURGICAL PROCEDURE. LENS WITH SAME MODEL AND LOWER DIOPTER OF +15.5 WAS USED AS REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8920182 ↗
• InjuryJul 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCT225 17.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT¿S OPERATIVE EYE DUE TO THE PATIENT EXPERIENCING DOUBLE VISION THAT WOULD NOT GO AWAY. THE REPLACEMENT LENS WAS A NON-J&J LENS. AN INCISION ENLARGEMENT WAS REQUIRED, HOWEVER NO COMPLICATIONS WERE REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8751692 ↗
• InjuryOct 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT HAS REPORTEDLY BECOME VERY HYPEROPIC AND NEEDS TO HAVE A LENS EXCHANGE. A PLANNED EXPLANT IS SCHEDULED TO BE PERFORMED ON (B)(6) 2017. THE REPLACEMENT LENS IS NOT KNOWN YET. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6950538 ↗
• InjuryJul 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS UNCOMFORTABLE WITH LENS THAT WAS IMPLANTED IN LEFT EYE FOR FAR VISION. LENS WAS EXPLANTED AND REPLACED WITH ONE FOR NEAR VISION.

  Patient problems: Discomfort; No Code Available

  MAUDE report 6751676 ↗