TECNIS IOL ZXT225 (REF ZXT225U260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474605916), received between Mar 6, 2017 and Aug 19, 2020 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryAug 19, 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 IMPLANTED BUT LATER EXPLANTED DUE TO THE PATIENT EXPERIENCING DIFFICULTY WITH HALOS, GLARE, AND STARBURSTS. THE EXPLANTED LENS WAS REPLACED WITH A DIFFERENT MODEL (ZCT150) AND LOWER DIOPTER POWER, 25.0 IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 10423842 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO MYOPIC MISS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES PERFORMED. THE PATIENT IS IN GOOD CONDITION POST-OP AND THIS TIME HAPPY WITH THEIR VISION.

  Patient problems: No Code Available

  MAUDE report 8863917 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT225, +26.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE PATIENT EXPERIENCING RESIDUAL MYOPIA. REPORTEDLY LENS WITH MODEL ZXT225, +25.0 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY PERFORMED. PATIENT WAS DOING WELL AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7671967 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED INFLAMMATION, GLARES AND LIGHT SENSITIVITY ON BOTH EYES ON A POST ¿OP EXAM AFTER IMPLANTATION OF A TECNIS SYMFONY MULTIFOCAL MODEL ZXT225 INTRAOCULAR LENS (IOL) IN BOTH EYES. BOTH INITIAL PROCEDURES WERE DONE IN MAY 2017. THE SURGERY CENTER INDICATED THE SURGERIES WENT WELL AND THE PATIENT OVERALL HAS BEEN SATISFIED WITH VISION. THE UNCORRECTED DISTANCE VISION HAS RANGED BETWEEN 20/30 TO 20/40 IN EACH EYE AND THE UNCORRECTED NEAR VISION HAS RANGED BETWEEN J2 TO J3 FOR EACH EYE. THE REFRACTION HAS BEEN -0.25 SPHERE FOR THE RIGHT EYE AND LEFT EYE. THE PATIENT COMPLAINT¿S THAT IS THAT THE NIGHT TIME GLARE REALLY BOTHERS HER AND THE PATIENT DOES NOT LIKE TO GO OUT AT NIGHT BECAUSE OF THAT. THE PATIENT ALSO FINDS CERTAIN LIGHTING TO BE QUITE BOTHERSOME. THE PATIENT WAS TREATED WITH ALPHAGAN DROPS AND PILOCARPINE DROPS. THE SURGERY CENTER RECOMMENDED TRYING ANTI-REFLECTIVE COATING AT NIGHT AND DURING THE DAY UV PROTECTIVE SUNGLASSES. THE PATIENT FINDS NOTHING HAS HELPED WITH THE GLARE. THE PATIENT HAS HAD LONGSTANDING POST-OP INFLAMMATION THAT HAS RECENTLY SETTLED DOWN USING DUREZOL DROPS. THE PATIENT¿S SYMPTOMS ARE INTERFERING WITH DAILY

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6995345 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 26.0 DIOPTER WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING BLURRY VISION BOTH NEAR AND DISTANCE. THE LENS WAS REPLACED WITH ANOTHER ZXT225 IOL OF A LOWER DIOPTER (25.0). THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO SUTURES REQUIRED AT EXPLANT. THERE WAS NO PATIENT POST-OP INJURY REPORTED. THE EXPLANTED LENS WAS CUT INTO 4 PIECES AND WILL NOT BE AVAILABLE FOR RETURN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6559263 ↗
• InjuryMar 6, 2017Adverse 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 FORM THE PATIENT'S EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF VISUAL DISTURBANCES. NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6383023 ↗