TECNIS IOL ZCT225 (REF ZCT225U125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474552586), received between Dec 19, 2016 and Nov 11, 2020 — classified as 2 injuries, 1 malfunction.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT BEGAN SEEING A DARK SPOT ON CORNER OF HER RIGHT EYE POST-IMPLANT OF AN INTRAOCULAR LENS (IOL). PATIENT HAD NOT TAKEN EYES DROPS. THROUGH FOLLOW-UP, IT WAS LEARNED THE SURGEON DIAGNOSED ISSUE AS A RETINAL DETACHMENT. ON (B)(6) 2020, THE PATIENT HAD SURGERY TO REPAIR HER RETINA. (B)(6) 2020, 1-DAY POST-OPERATIVE APPOINTMENT, PATIENT WAS GIVEN PROTECTIVE EYE SHIELD TO WEAR. ON (B)(6) 2020, THE SURGEON TOLD PATIENT SHE IS HEALING WELL. THE PATIENT IS FOLLOWING DIRECTIONS AND USING EYE DROPS 3X/DAY. THE PATIENT DOES NOT KNOW IF THERE IS AN ISSUE WITH THE LENS OR IT IS JUST HER EYE. THE SURGEON HAS NOT COMMENTED ABOUT THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Retinal Detachment; Visual Disturbances

  MAUDE report 10824067 ↗
• MalfunctionOct 29, 2019Break; Break

  THIS REPORT SUMMARIZES <NOE> 2 </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 9251475 ↗
• InjuryDec 19, 2016Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZCT225 INTRAOCULAR LENS (IOL) IN THE PATIENT'S LEFT EYE, THE LENS ROTATED 60 DEGREES OFF AXIS. AN ASTIGMATISM FIX CALCULATOR CALCULATED THAT THE PATIENT WILL END UP WITH APPROXIMATELY 1 DIOPTER HYPEROPIC WITH APPROXIMATELY 0.5 DIOPTER OF HIS CYLINDER OVERCORRECTED WITH SIMPLE ROTATION. THE LENS WAS EXPLANTED ON (B)(6) 2016. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY OR SUTURES REQUIRED. THE PATIENT IS DOING FINE AND WILL BE BACK IN THREE WEEKS FOR A POST-OP VISIT.

  Patient problems: No Code Available

  MAUDE report 6187395 ↗