TECNIS IOL ZXT375 (REF ZXT375U125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606821), received between Mar 15, 2017 and Jun 10, 2021 — classified as 4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT A DOCTOR IS POSSIBLY GOING TO EXPLANT AN INTRAOCULAR LENS (IOL) THAT WAS IMPLANTED IN 2017 DUE TO THE PATIENT EXPERIENCING GLARE SINCE SURGERY. UPON FOLLOW-UP IT WAS CONFIRMED THAT THE PATIENT HAS A LENS IMPLANTED IN BOTH THE LEFT AND RIGHT EYE. IT WAS NOTED THAT THE PATIENT IS ALSO EXPERIENCING HALOS, BUT IT IS UNKNOWN WHEN THIS SYMPTOM BEGAN. THE PATIENT'S VISUAL CONCERNS ARE REPORTED TO BE DEBILITATING AND ARE SIGNIFICANTLY INTERFERING WITH DAILY ACTIVITIES. BECAUSE OF THIS, THE PATIENT WANTS THE LENSES REMOVED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR IS FOR REPORT ON SUSPECT PRODUCT IN LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SUSPECT PRODUCT IN RIGHT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11972639 ↗
• InjuryJun 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT375, +12.5 DIOPTER) WAS IMPLANTED IN PATIENT¿S RIGHT EYE. PATIENT DEVELOPED SEVERE FUNGAL INFECTION WHICH LED TO ENUCLEATION OF THE RIGHT EYE. THE CURRENT PATIENT STATUS IS PERMANENT IMPAIRMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Fungal Infection; No Code Available; Visual Impairment

  MAUDE report 7605473 ↗
• InjuryMar 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD SYMFONY INTRAOCULAR LENSES (IOL) IMPLANTED IN THEIR LEFT AND RIGHT EYE. IT WAS REPORTED BY THE PATIENT THAT AT ALMOST THREE MONTHS, HE HAS BEEN EXPERIENCING SEVERE GLARE CAUSING EYESTRAIN. THE PATIENT STATES THAT THE NIGHT TIME GLARE IS HORRIBLE AND THAT HIS VISION IS 10 TIMES WORSE. THE PATIENT IS ALSO EXPERIENCING HALOS AROUND OTHER LIGHTS. ADDITIONALLY, THE PATIENT IS ALSO EXPERIENCING STARBURST, COBWEBS, AND STREAKING FROM HEADLIGHTS AND STREET LIGHTS. ON THE LEFT EYE THE PATIENT SEES A STREAK AT 2:00 TO 8:00. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE RIGHT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6408423 ↗
• InjuryMar 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD SYMFONY INTRAOCULAR LENSES (IOL) IMPLANTED IN THEIR LEFT AND RIGHT EYE. IT WAS REPORTED BY THE PATIENT THAT AT ALMOST THREE MONTHS, HE HAS BEEN EXPERIENCING SEVERE GLARE CAUSING EYESTRAIN. THE PATIENT STATES THAT THE NIGHT TIME GLARE IS HORRIBLE AND THAT HIS VISION IS 10 TIMES WORSE. THE PATIENT IS ALSO EXPERIENCING HALOS AROUND OTHER LIGHTS. ADDITIONALLY, THE PATIENT IS ALSO EXPERIENCING STARBURST, COBWEBS, AND STREAKING FROM HEADLIGHTS AND STREET LIGHTS. ON THE LEFT EYE THE PATIENT SEES A STREAK AT 1:30 TO 7:30. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE LEFT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6408422 ↗