TECNIS IOL ZCT225 (REF ZCT225U200)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474552739), received between Dec 2, 2016 and Aug 28, 2020 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT AN INTRAOCULAR LENS (IOL) WILL BE EXPLANTED. THROUGH FOLLOW-UP, IT WAS LEARNED THAT THE PATIENT HAD VISUAL ISSUES, THEREFORE, THE LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. THE IOL WAS DISCARDED. THERE WERE NO UNPLANNED SUTURES OR A VITRECTOMY REQUIRED WHEN REMOVING THE LENS. ANOTHER JOHNSON & JOHNSON LENS MODEL ZCB00, HIGHER DIOPTER 21.0 WAS IMPLANTED AS A REPLACEMENT. THE EXCHANGE OF LENS WAS SUCCESSFUL AND THE PATIENT IS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 10468450 ↗
• InjuryOct 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 BECAUSE THE SURGEON SELECTED A TORIC IOL, BUT WANTED A SYMPHONY IOL. THE REPLACEMENT LENS IS A ZXT225 19.0 DIOPTER. INCISION WAS NOT ENLARGED AND NO SUTURE USED. REPORTEDLY, NO COMPLICATIONS POST SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9227560 ↗
• MalfunctionJul 8, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A ZCT225 20.0 DIOPTER INTRAOCULAR LENS (IOL) HAD LINT (DEBRIS) WHICH WAS NOTICED TO BE ON THE LENS WHEN REMOVING FROM PACKAGING. VIA FOLLOW-UP THE CUSTOMER CONFIRMED THAT THE PROCEDURE WAS COMPLETED WITH A BACKUP IOL OF THE SAME MODEL ZCT225 AND THERE WERE NO COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8768268 ↗
• InjuryJun 7, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS, IMPLANTED INTO THE PATIENT'S RIGHT EYE, WAS EXPLANTED DUE TO POOR VISUAL OUTCOME. THE LENS ROTATED MORE THAN 30 DEGREES. NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS PERFORMED. FOLLOWING THE EXPLANT, THE PATIENT BEST CORRECTED VISUAL ACUITY (BCVA) WAS REPORTED AS 20/15. NO ADDITIONAL INFORMATION WAS RECEIVED. VISUAL ACUITY PRE OP: 20/50; VISUAL ACUITY POST OP DAY 1: 20/30.

  Patient problems: No Code Available

  MAUDE report 8680830 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS OPERATIVE EYE ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2018 DUE TO RESIDUAL REFRACTIVE ERROR. THERE WAS NO SURGICAL INTERVENTION PERFORMED AND A ZA9003 IOL WAS IMPLANTED AS A REPLACEMENT. THE IOL WAS DISCARDED AND NOT BEING RETURNED.

  Patient problems: No Code Available

  MAUDE report 8211337 ↗
• MalfunctionNov 6, 2017Crack; Crack

  IT WAS REPORTED THAT A ZCT225 20.0 DIOPTER INTRAOCULAR LENS (IOL) CRACKED IN HALF AFTER BEING INSERTED INTO THE RIGHT EYE (OD). THE LENS WAS REMOVED AND REPLACED IN THE SAME PROCEDURE. THERE WAS NO INCISION ENLARGEMENT OR VITRECTOMY PERFORMED. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT HAS EXCELLENT VISION POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7004056 ↗
• InjurySep 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 20.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED DUE TO A POST SURGICAL REFRACTIVE SURPRISE. ADDITIONAL INFORMATION NOT PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6857028 ↗
• InjuryDec 2, 2016Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZCT225 20.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE LENS BEING TOO NEAR SIGHTED FOR THE PATIENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. THE LENS WAS REPLACED WITH THE SAME MODEL, A SMALLER 18.0 DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6142453 ↗