TECNIS IOL ZXT375 (REF ZXT375U135)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606845), received between Oct 2, 2018 and Jun 10, 2021 — classified as 3 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 3 most recent of 3 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 RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE SUSPECT PRODUCT IN LEFT EYE.

  Patient problems: Halo; Visual Disturbances

  MAUDE report 11972632 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 13.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE DOCTOR MISSED THE TARGET OUTCOME. THE REPLACEMENT LENS WAS A ZXT150 14.0 DIOPTER LENS, THERE WERE NO COMPLICATIONS WITH THE EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7998500 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT375, +13.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING MECHANICAL COMPLICATION, BLURRY VISION, NEAR AND FAR 20/70 PLUS 1. REPORTEDLY, THE LENS WAS REPLACED WITH THE DIFFERENT MODEL, A ZXT300, +15.0, A LARGER DIOPTER. PATIENT WAS DOING WELL. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURY, NO VITRECTOMY PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 7928936 ↗