TECNIS IOL ZCT225 (REF ZCT225U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552647), received between May 5, 2017 and May 17, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

• InjuryMay 17, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED ZCT225 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE LENS WAS EXPLANTED (B)(6) 2019 DUE TO COMPLAINTS OF SPHERICAL AND TORIC POWERS WERE OFF. IT WAS REPORTED THE REPLACEMENT LENS WAS A ZCT150 16.0 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient; Suture Abrasion

  MAUDE report 8620376 ↗
• InjuryMar 14, 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 FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE DUE TO ASTIGMATISM. PATIENT STARTED COMPLAINING AFTER SURGERY. THE REPLACEMENT LENS WAS A ZCT150 15.0 DIOPTER LENS. PATIENT IS REPORTED TO BE DOING FINE POST EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8419267 ↗
• InjuryJan 28, 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 15.5 DIOPTER) BECAUSE OF PATIENT EXPERIENCING ANSIOMETROPIA. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES REQUIRED AT EXPLANT. A DIFFERENT MODEL LENS OF THE SAME DIOPTER WAS USED AS THE REPLACEMENT LENS. PATIENT WAS DOING FINE POST EXCHANGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8283838 ↗
• InjuryOct 17, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT225 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017 AND ROTATED TO 160 DEGREES FROM THE TARGET DEGREE OF 120, WHICH WAS A DIFFERENCE OF 40 DEGREES. IN ADDITION, THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/60 AND SHE COMPLAINED OF BLURRY VISION. THEREFORE, A SECOND SURGERY WAS PERFORMED ON (B)(6) 2017 TO ROTATE THE LENS BACK TO THE 120 DEGREE TARGET. POST-OPERATIVELY, THE LENS ROTATED TO 140 DEGREE AND THE PATIENT'S VISUAL ACUITY WAS 20/40. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6956637 ↗
• MalfunctionMay 5, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) HAD ROTATED BY 43 DEGREES TEN DAYS POST IMPLANTATION. REPORTEDLY, THE POST-OP STATUS OF THE PATIENT WAS STABLE. THERE WERE NO INJURIES AND NO COMPLAINTS FROM THE PATIENT. TO DATE THE LENS REMAINS IMPLANTED AND THERE ARE NO PLANS TO REPOSITION THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6549501 ↗