TECNIS IOL ZXT375 (REF ZXT375U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606913), received between Jan 10, 2017 and Jun 9, 2020 — classified as 4 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT 1 MONTH STUDY VISIT, THE SUBJECT HAD DIFFICULTY AND WAS MODERATELY BOTHERED BY HALOS AND STARBURSTS LIMITING NIGHT DRIVING AN INTRAOCULAR LENS (IOL) IN THE LEFT EYE. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT COMPLAINED OF BLURRED VISION/DIFFICULTY WITH VISION NEAR, HALOS, NIGHT GLARE, AND STARBURSTS. SUBJECT ALSO COMPLAINS OF FLASHES OF LIGHT IN THE LEFT EYE. THE MONOCULAR UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) - OD 20/15; OS 20/15. MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) ¿ OD 20/15; OS 20/15. THE LENS REMAINS IMPLANTED. THERE WAS NO TREATMENT PROVIDED OR PLANNED. THE SUBJECT RETURNED FOR THE 6 MONTH STUDY VISIT. THE SUBJECT REPORTED BEING VERY BOTHERED BY POOR LIGHT VISION. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS THE SUBJECT REPORTED DIFFICULTY WITH VISION IN LOW LIGHT AND DECREASED NEAR VISION WITH AN INTRAOCULAR LENS (IOL). THE SUBJECT ALSO COMPLAINS OF STROBE LIGHT EFFECT IN THE OUTER CORNER OF THE LEFT EYE OCCASIONALLY. THE MONOCULAR UCDVA: OD 20/15; OS 20/20. MONOCULAR BCDVA: OD 20/15; OS 20/15. THE PI (PRINCIPLE INVESTIGATOR) ASSESSED THE COMPLAINT TO BE RELATED TO THE PROPERTIES OF THE IOL AND THE SYMPTOMS WERE NOTED AS

  Patient problems: Blurred Vision; Halo; Visual Impairment

  MAUDE report 10136508 ↗
• InjuryAug 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN EXPLANT AND REPLACEMENT PERFORMED ON (B)(6) 2017 IN THE LEFT EYE DUE TO REFRACTIVE ERROR / INTRAOCULAR COMPLICATION. THE TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT375 17.0 DIOPTERS, WAS EXPLANTED AND REPLACED WITH MODEL ZXT150 19.5 DIOPTERS. PATIENT IS DOING WELL AND THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES DONE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6804870 ↗
• InjuryMay 11, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT375 17.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO UNEXPECTED RESIDUAL REFRACTION AND BLURRY VISION. ADDITIONALLY, IT WAS LEARNED THAT THE LENS ROTATED TWICE AND DID NOT STAY IN PLACE. THE LENS ORIGINAL AXIS WAS 104 DEGREES. AT WEEK 1 POSTOP THE LENS ROTATED 15 DEGREES AND ROTATED 45 DEGREES BY POSTOP WEEK 2. THE ROTATION NEVER RESULTED IN A SATISFACTORY REFRACTION OR VISUAL ACUITY AND ADDITIONAL CALCULATIONS SHOWED THAT EVEN IF THE LENS WAS ROTATED INTO AN IDEAL POSITION, IT WOULD NOT HAVE ADEQUATELY CORRECTED THE ASTIGMATISM. FURTHERMORE, AT ONE WEEK POST-OP THE PATIENT HAD A RESIDUAL REFRACTION OF -2.50 +3.50 X 90. PATIENT HAD UNCORRECTED VISUAL ACUITY (VA) OF 20/150 AT DISTANCE AND 20/100 AT NEAR. PATIENT REFRACTS TO 20/20+. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE LENS WAS REPLACED WITH A NON-AMO LENS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6562362 ↗
• InjuryJan 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO POST REFRACTIVE OR OVER MINUS ISSUE. LENS WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6239892 ↗