TECNIS IOL ZCT225 (REF ZCT225U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474552661), received between Apr 27, 2017 and Jan 31, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• InjuryJan 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE ZCT225 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF IOL DISPLACEMENT AND REPLACED WITH A ZA9003 16.0 DIOPTER IOL. THERE WERE NO SUTURE(S) AND NO MEDICATION WAS PRESCRIBED HOWEVER, VITRECTOMY WAS PERFORMED. PATIENT STATUS WAS REPORTED AS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16275356 ↗
• MalfunctionJul 30, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENTS. THE EVENTS WERE RELATED TO LENS DAMAGED. THERE WERE NO PATIENT INJURIES REPORTED ASSOCIATED TO THE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844256 ↗
• MalfunctionMay 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THERE WAS A SPOT ON A ZCT225 16.5 DIOPTER INTRAOCULAR LENS (IOL) WHILE LOADING. THERE WAS NO PATIENT CONTACT. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Patient Involvement

  MAUDE report 8634819 ↗
• InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 16.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT''S RIGHT EYE (OD) ON (B)(6) 2018. THE LENS WAS EXPLANTED (B)(6) 2018, DUE TO A HYPEROPIC OUTCOME AND RESIDUAL CYLINDER. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7463340 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO RESIDUAL REFRACTIVE ERROR. THE LENS WAS EXPLANTED WITH NO COMPLICATIONS, NO INJURY AND NO ADDITIONAL PROCEDURES. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A HIGHER DIOPTER SIZE. PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6527049 ↗