TECNIS IOL ZCT225 (REF ZCT225U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05050474552753), received between Oct 4, 2016 and Dec 16, 2019 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Positioning 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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 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 FROM THE PATIENT'S LEFT EYE DUE TO PATIENT NOT SEEING WELL. IT WAS REPLACED WITH THE SAME MODEL IOL BUT DIFFERENT DIOPTER SIZE. VISUAL ACUITY PRE-OP 20/25, 20/400, GLARE. POST-OP VISUAL ACUITY 20/30 +2. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9474436 ↗
• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZCT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF REFRACTIVE ERROR. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCT150 21.5 DIOPTER IOL WITHOUT ANY OTHER INTERVENTION REQUIRED. PATIENT OUTCOME WAS REPORTED AS DOING WELL. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED (B)(6) 2019 AS THE DATE THE REFRACTIVE ERROR WAS FIRST OBSERVED. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/30 AND POST-OP BCVA WAS 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8829511 ↗
• InjuryJan 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZCT225 +21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF A FEMALE PATIENT ON (B)(6) 2018. REPORTEDLY, THE PATIENT WAS EXPERIENCING ASTHENOPIA AND NEAR VISION PROBLEMS SINCE DAY ONE POST-OP. AS A RESULT, THE LENS WAS EXPLANTED ON (B)(6) 2018 AND A ZCT225 +24.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. THE PATIENT FULLY RECOVERED AND DOING BETTER WITH THE NEW LENS. VISUAL ACUITY PRE-INITIAL IMPLANT: 20/40. VISUAL ACUITY POST-INITIAL IMPLANT: 20/40 +1. VISUAL ACUITY POST-REPLACEMENT: 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8270060 ↗
• MalfunctionJan 15, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZCT225, 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE EYE OF A FEMALE PATIENT ON (B)(6) 2018. REPORTEDLY, THE LENS ROTATED FROM THE ORIGINAL PLACEMENT AND IT WAS REPOSITIONED ONE WEEK AFTER THE INITIAL SURGERY. THE SURGEON PLACED A CTR (CAPSULAR TENSION RING) AND SUTURED THE WOUND BUT THE LENS ROTATED AGAIN; SO IT WAS EXPLANTED AND REPLACED WITH A NON-JOHNSON & JOHNSON LENS. IT WAS LEARNT THAT THE IOL ROTATED 50 DEGREES. THERE WAS UNEXPECTED POST-OP REFRACTION. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO PATIENT POST-OP INJURY OCCURRED. THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8247449 ↗
• InjuryAug 15, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT A ZCT225 21.0 DIOPTER LENS WAS INSERTED AND REMOVED DURING THE SAME SURGICAL PROCEDURE AS IT WAS NOT SITTING WELL IN THE EYE RESULTING IN THE CAPSULAR BAG TEARING. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A NON-JOHNSON AND JOHNSON LENS. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7787637 ↗
• InjuryMar 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO RESIDUAL IRREGULAR ASTIGMATISM THAT DID NOT ALLOW THE PATIENT TO BE CORRECTED WITH GLASSES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS AN AAB00 22.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. ALSO, THE PATIENT HAS BEEN UNABLE TO USE HARD CONTACT LENSES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7351612 ↗
• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE ON (B)(6) 2016. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH A ZXT300 22.0 DIOPTER IOL. REPORTEDLY, PATIENT WAS DOING WELL POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7211362 ↗
• InjuryDec 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 21.0 DIOPTER WAS EXPLANTED. LENS WAS REPLACED WITH THE SAME MODEL LENS OF A LOWER DIOPTER (20.5). DESPITE FOLLOW UP ATTEMPTS THE REASON FOR THE EXCHANGE AND ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6161683 ↗
• InjuryNov 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZCT225 21.0.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE OF A MALE PATIENT DUE TO RESIDUAL REFRACTIVE ERROR. THE LENS WAS REPLACED WITH THE SAME MODEL LENS OF A HIGHER DIOPTER (22.0). THERE WAS NO COMPLICATION AND NO PATIENT INJURY. NO INCISION ENLARGEMENT WAS REQUIRED OR OTHER ADDITIONAL PROCEDURES.

  Patient problems: No Code Available

  MAUDE report 6084722 ↗
• InjuryOct 4, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZCT225 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO RESIDUAL REFRACTIVE ERROR. AT EXPLANT THERE WAS NO COMPLICATION OR INJURY. A NEW LENS WAS IMPLANTED. CURRENT PATIENT STATUS IS NOTED AS THE PATIENT HAS RECOVERED.

  Patient problems: No Code Available

  MAUDE report 5995689 ↗