TECNIS IOL ZCT225 (REF ZCT225U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474552708), received between Jul 26, 2017 and Sep 23, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A CUSTOMER EXCHANGED A MODEL PCB00 INTRAOCULAR LENS (IOL) FOR ANOTHER PCB00 DUE TO PATIENT¿S VISION. THE EXPLANTED LENS WAS DISCARDED AFTER EXPLANT SINCE IT WAS REMOVED AND CUT INTO PIECES. AT A LATER DATE IT WAS LEARNED THAT THE INITIALLY IMPLANTED LENS WAS NOT A PCB00, BUT RATHER THE REPLACEMENT LENS IS A MODEL PCB00 18.0 DIOPTER IOL, AND THE INITIALLY IMPLANTED LENS THAT WAS SUBSEQUENTLY EXPLANTED WAS A MODEL ZCT225 18.5 DIOPTER IOL. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. NO PATIENT POST-OP INJURY. PATIENT IS HAPPY WITH THE NEW LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10571720 ↗
• InjurySep 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO RESIDUAL MYOPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. THE IOL WAS REPLACED WITH A ZCT150. THE PATIENT IS WELL POST-OP. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9101432 ↗
• InjuryApr 21, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS (MODEL ZCT225, +18.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE OF THE LENS DISLOCATION. THE DOCTOR WAS NOT ABLE TO STABILIZE THE LENS TO KEEP IN AT THE AXIS NEEDED. A ANTERIOR CHAMBER INTRAOCULAR LENS WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, AND NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7449692 ↗
• MalfunctionJul 26, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT DEBRIS WAS OBSERVED ON AN INTRAOCULAR LENS (IOL) DURING HANDLING BUT PRIOR TO INSERTION WITH NO PATIENT CONTACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6743153 ↗