TECNIS IOL ZCU225 (REF ZCU225U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474658967), received between Dec 30, 2020 and Aug 14, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2024Unstable; Unstable

  IT WAS REPORTED THAT PATIENT HAD A SMALL RADIAL TEAR WHILE USING THE CATALYS SYSTEM. AN INTRAOCULAR LENS (IOL) WAS PLACED HOWEVER, PATIENT HAD TO RETURN BACK TO SURGERY AS THE IOL ROTATED GREATER THAN 10 DEGREES AND HAD TO BE EXCHANGED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS AGAINST THE IOL. A SEPARATE REPORT WILL BE FILED AGAINST THE CATALYS SYSTEM.

  Patient problems: Capsular Bag Tear

  MAUDE report 19987582 ↗
• InjuryJul 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S OCULAR SINISTER (LEFT EYE). IN A SECONDARY SURGICAL PROCEDURE, THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF THE PATIENT REQUIRING MORE CYLINDER (CYL) AND REPLACED WITH ANOTHER JOHNSON & JOHNSON LENS, MODEL ZCU375 19.0 DIOPTER. THERE WAS NO INCISION ENLARGEMENT, NO SUTURE(S), NO VITRECTOMY, NO DELAY IN PROCEDURE, NO MEDICAL ATTENTION WAS REQUIRED, AND NO MEDICATION OUTSIDE OF STANDARD CARE WAS PRESCRIBED. PATIENT STATUS WAS REPORTED AS TEMPORARILY IMPAIRED AND UNKNOWN. THE EXPLANTED IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 17368409 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE IN THE SECONDARY PROCEDURE. THE REASON FOR THE EXPLANT IS UNKNOWN/NOT PROVIDED. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Eye Injury

  MAUDE report 13897623 ↗
• InjuryFeb 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS TORIC INTRAOCULAR LENS WAS REMOVED FROM THE PATIENT'S OPERATIVE EYE DUE TO UNEXPECTED POST-OP REFRACTION. THE REPLACEMENT LENS IS A ZCU300 19.0 DIOPTER WITH NO COMPLICATIONS. NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Visual Impairment

  MAUDE report 11290322 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE PATIENT IS SLIGHTLY HYPEROPIC POSTOPERATIVE, LIKELY FROM HER LENS SITTING A LITTLE FURTHER BACK BECAUSE SHE HAS A BIG BAG FROM HIGH MYOPIA. THE LENS DID NOT ROTATE, HER LENS IS ALIGNED PROPERLY. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PATIENT'S PRE-OP BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/60 PINHOLE (PH) 20/25 IN THE LEFT EYE. PATIENT IS SLIGHTLY HYPEROPIC POST-OP, EXPLANTING THE LENS WITH A HIGHER POWER (21.0) TO HELP CORRECT FOR THIS. AT EXCHANGE THERE WAS NO CAPSULE TEAR, NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES REQUIRED. POST-OP UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/20, BCDVA 20/20 AT 1 WEEK POST OP ON (B)(6) 2020. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Therapeutic Effects, Unexpected

  MAUDE report 11099366 ↗