TECNIS IOL ZXT375 (REF ZXT375U105)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474606784), received between Feb 13, 2017 and Sep 5, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2017Unintended Movement; Unintended Movement

  REPORTEDLY, A PHYSICIAN COMPLAINED A CASE IN WHICH A TORIC IOL WAS IMPLANTED AND ESSENTIALLY PROVIDED NO ASTIGMATISM CORRECTION. THE ZXT375 10.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN A FEMALE PATIENT'S LEFT EYE ON (B)(6)2017. PATIENT'S VISION WAS ON 2100. HOWEVER, ON (B)(6)17 PATIENT'S VISUAL ACUITY WAS 20/70, LENS WAS ROTATED ON (B)(6)2017. POST ROTATION, PATIENT'S VISUAL ACUITY AS 20/60. AND ON (B)(6)2017 THE PATIENT'S VISUAL ACUITY FOR DISTANCE WAS 20/40, INTERMEDIATE: 20/50, AND NEAR 20/80. THE REFRACTION WAS PLANO + 125 AT 10. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6843722 ↗
• InjuryFeb 13, 2017Unintended Movement; Unintended Movement

  A PATIENT REPORTED EXPERIENCING STARBURSTS, RINGS, HAZE AND HALOS. SHE ALSO NOTED NOT EXPERIENCING HAZINESS AROUND LIGHTS. THROUGH FOLLOW UP, THE PATIENT CONFIRMED RECEIVING A MULTIFOCAL SYMFONY LENS ON (B)(6) 2016. THE PATIENT THINKS THAT HER DISTANCE VISION WAS NOT CORRECTED. THE STARBURSTS HAS IMPROVED, HOWEVER SHE IS STILL EXPERIENCING RINGS AND HAZINESS. THE PATIENT ALSO MENTIONED THAT DURING HER FOLLOW-UP HER PHYSICIAN TOLD HER THAT THE LENS MOVED, BUT THEY WOULD HAVE TO WAIT UNTIL THE PHYSICIAN WILL DO LASER CUTS TO TREAT THE LENS DISLOCATION. THE DOCTOR MENTIONED THAT SHE HAS ASTIGMATISM AS WELL. THE PATIENT CAN ONLY DRIVE DURING THE DAY. SHE HAS NO CLOSE VISION OR INTERMEDIATE VISION AS SHE CANNOT READ LARGE PRINTS. HER DISTANCE VISION WAS BLURRY, HOWEVER, WHEN SHE WENT FOR A FOLLOW-UP APPOINTMENT HER DOCTOR GAVE HER CONTACT LENSES BECAUSE OF HER ASTIGMATISM AND NOW THE DISTANCE IS CLEARER. FOLLOW-UP WITH THE PATIENT'S PHYSICIAN CONFIRMED THAT A ZXT375 10.5 DIOPTER WAS IMPLANTED INTO PATIENT'S EYE. ON DAY 1 POST-OP, IT WAS NOTED THAT THE LENS ROTATED. ONE WEEK POST-OP THE ROTATION HAD IMPROVED. PATIENT'S MOST RECENTLY FOLLOW UP VISIT CONFIRMED THAT PATIENT VISUAL ISSUES AR

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

  MAUDE report 6327761 ↗