TECNIS IOL ZXT225 (REF ZXT225U160)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474605718), received between Apr 28, 2017 and Jul 25, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 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.

• InjuryJul 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) MODEL ZXT225U160, WITH SERIAL NUMBER (SN) (B)(4), WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE) ON (B)(6) 2019. IOL WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF INTOLERANCE TO HALOS AND BLURRINESS. IT WAS REPORTED THE INCISION WAS ENLARGED AND SUTURE(S) WERE REQUIRED. PRE-OPERATIVE VISUAL ACUITY WAS REPORTED AS 20/50+ AND POST-OPERATIVE VISUAL ACUITY WAS 20/20- CORRECTED. ZXT225 IOL WAS REPLACED WITH A PCB00 18.5 DIOPTER IOL. THE ZXT225 IOL WILL NOT BE RETURNED AS IT WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8825782 ↗
• InjuryJul 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT225 +16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. THE PATIENT VISITED THE DOCTOR ON (B)(6) 2017, AND COMPLAINED OF PSEUDOPAKIA OU (BOTH EYES). THE PATIENT WAS FRUSTRATED THAT HE COULD NOT READ, WHICH WAS AFFECTING HIS WORK. HE BOUGHT +1.25 OTC (OVER-THE-COUNTER) GLASSES WITH NO HELP. INTERMEDIATE VISION HAS IMPROVED. DISTANCE VISION OS STABLE; FUZZY OD (RIGHT EYE). ALSO NOTED WAS HALOS. UNCORRECTED VISUAL ACUITY OD: 20/100-2 DISTANCE; PH (PINHOLE) 20/80-2; J5 NEAR. THE LENS WAS EXPLANTED ON (B)(6) 2018, DUE TO LACK OF NEAR VISION. THE INCISION WAS ENLARGED TO REMOVE THE LENS BUT NO VITRECTOMY WAS PERFORMED AND NO PATIENT INJURY WAS REPORTED. ANOTHER MANUFACTURER'S LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT WAS REPORTED TO BE FINE WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS TO RECORD THE LENS IN THE RIGHT EYE. A SEPARATE MDR WILL BE FILED FOR THE LENS IN THE LEFT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 7737448 ↗
• MalfunctionDec 1, 2017Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT HAIR WAS FOUND ON A ZXT225 16.0 DIOPTER INTRAOCULAR LENS (IOL) WHEN IT WAS BEING TAKEN OUT OF IT'S PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7077538 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A ZXT225 16.0 DIOPTER INTRAOCULAR LENS WAS PLANNED TO BE EXPLANTED DUE TO PATIENT EXPERIENCING GLARES AT NIGHT AND IT'S NOT IMPROVING. HOWEVER, THROUGH FOLLOW UP IT WAS LEARNED THAT THE PATIENT IS TOLERATING THE LENS BETTER AND THERE ARE NO PLANS TO EXPLANT LENS AT THIS TIME. THE PATIENT WAS PRESCRIBED ALPHAGAN. BOTH THE PATIENT AND PHYSICIAN DO NOT WANT TO HAVE TO EXPLANT THE LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6559182 ↗
• InjuryApr 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PHYSICIAN IS PLANNING ON EXPLANTING A SYMFONY LENS FROM A PATIENT'S LEFT EYE (OS). THE FEMALE PATIENT HAS LOUSY VISION IN BOTH EYES. THE PATIENT'S VISION IN THEIR LEFT EYE IS J10. THE PHYSICIAN WILL PROCEED WITH EXPLANTING THE OD FIRST. PATIENT'S VISUAL ACUITY IN THE RIGHT EYE IS J16. AT THIS TIME, A DATE FOR THE LENS EXPLANTS HAS NOT BEEN SCHEDULED. THIS REPORT REPRESENTS THE LENS IMPLANTED IN THE PATIENT'S LEFT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6532119 ↗