TECNIS IOL ZXT225 (REF ZXT225U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474605886), received between Sep 19, 2017 and Mar 14, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT BEING VERY BOTHERED BY HALOES IN THE LEFT EYE (OS). A 10-0 SUTURE WAS PLACED AT EXPLANT. THE LENS WAS REPLACED WITH A ZCT150, 23.5 DIOPTER. THE PATIENT WAS REPORTED AS FINE POST OP. PATIENT'S POST OP VISUAL ACUITY WAS 20/40 AT POST OP DAY ONE; AND NOW 20/25. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8423372 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY INTRAOCULAR LENS (MODEL ZXT225 24.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING HALOS CAUSING DIZZINESS. A MODEL ZCB00 24.5 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Dizziness; Halo; No Code Available

  MAUDE report 8203923 ↗
• InjuryJul 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 24.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018, BECAUSE THE PATIENT REPORTED BLURRY VISION AND REQUESTED REMOVAL AND REPLACEMENT WITH A MONOFOCAL LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A MONOFOCAL LENS, MODEL Z9002 24.0 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7688835 ↗
• InjuryMar 23, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (IOL) MODEL ZXT225, +24.5 DIOPTER WAS EXPLANTED FROM PATIENT'S RIGHT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE WRONG TORIC POWER WAS IMPLANTED. REPORTEDLY, THE PATIENT HAD IRREGULAR ASTIGMATISM PRE-OP, AND A NON-J&J SYSTEM USED TO CALCULATE THE LENS POWER INTRAOPERATIVELY, SUGGESTED THE WRONG LENS POWER. THE SURGEON DID NOT EXPLANT THE LENS RIGHT AWAY BECAUSE HE WAS WAITING TO SEE IF THE PATIENT WAS GOING TO TOLERATE THE LENS. A ZXT375 +27.5 DIOPTER IOL WAS THEN IMPLANTED AS THE REPLACEMENT LENS FOR THE PATIENT. NO INCISION ENLARGEMENT, NO SUTURES WERE USED, NO VITRECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED DOING FINE WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7364917 ↗
• InjurySep 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ZXT225 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT WAS UNHAPPY AND EXPERIENCED HALOS AND GLARES. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THE LENS WAS REPLACED WITH A MODEL ZCT150 AND THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6878059 ↗