TECNIS IOL ZXT375 (REF ZXT375U195)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606968), received between Jul 9, 2018 and Oct 24, 2019 — 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.

• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INCLUDED IN A CLINICAL STUDY HAS BILATERAL ZXT375 INTRAOCULAR LENSES (IOLS) IMPLANTS. AT THE 4TH MONTH VISIT, THE PATIENT COMPLAINED OF BEING MODERATELY BOTHERED BY HALOS, MULTIPLE/DOUBLE VISION, SENSITIVITY TO LIGHT, GLARE, POOR LOW LIGHT VISION, DIFFICULTY DRIVING AT NIGHT, AND READING. THERE IS NO PLANNED INTERVENTION. VISUAL ACUITY (VA) FOR BOTH EYES (OU) 20/20. IMPLANT DATE FOR LEFT EYE (OS) IS (B)(6) 2019, AND IMPLANT DATE FOR RIGHT EYE (OD) IS (B)(6) 2019. IT WAS LEARNED THAT AT THE 3-MONTH STUDY VISIT THE PATIENT REPORTED SOME BOTHER WITH VISUAL SYMPTOMS, BUT DID NOT AFFECT HIS DAILY LIVING. HOWEVER, AT THE 4TH MONTH VISIT, THE PREOPERATIVE MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITIES (BCDVAS) WERE OD 20/25 AND OS 20/25, SO THE DROP IS ONE LINE FROM THE PREOP VISIT. IN ADDITION, THERE WAS A DIAGNOSIS OF EPIRETINAL MEMBRANE (ERM) IN THE LEFT EYE AT THE 4-MONTH VISIT, WHICH THE SITE BELIEVES CONTRIBUTED TO THE LOWER-THAN-EXPECTED VISUAL ACUITY IN THIS EYE. THE SUBJECT REPORTED THAT THE VISUAL SYMPTOMS DID SIGNIFICANTLY INTERFERE WITH HER DAILY ACTIVITIES, AND MENTIONED DRIVING AND READING IN THE PATIENT REPORTED VISUAL SYMPTOM QUESTIONNAIRE

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9236626 ↗
• InjuryOct 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT INCLUDED IN A CLINICAL STUDY HAS BILATERAL ZXT375 INTRAOCULAR LENSES (IOLS) IMPLANTS. AT THE 4TH MONTH VISIT, THE PATIENT COMPLAINED OF BEING MODERATELY BOTHERED BY HALOS, MULTIPLE/DOUBLE VISION, SENSITIVITY TO LIGHT, GLARE, POOR LOW LIGHT VISION, DIFFICULTY DRIVING AT NIGHT, AND READING. THERE IS NO PLANNED INTERVENTION. VISUAL ACUITY (VA) FOR BOTH EYES (OU) IS 20/20. IMPLANT DATE FOR LEFT EYE (OS) IS (B)(6) 2019, AND IMPLANT DATE FOR RIGHT EYE (OD) IS (B)(6) 2019. IT WAS LEARNED THAT AT THE 3-MONTH STUDY VISIT THE PATIENT REPORTED SOME BOTHER WITH VISUAL SYMPTOMS, BUT DID NOT AFFECT HIS DAILY LIVING. HOWEVER, AT THE 4TH MONTH VISIT, THE PREOPERATIVE MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITIES (BCDVAS) WERE OD 20/25 AND OS 20/25, SO THE DROP IS ONE LINE FROM THE PREOP VISIT. IN ADDITION, THERE WAS A DIAGNOSIS OF EPIRETINAL MEMBRANE (ERM) IN THE LEFT EYE AT THE 4-MONTH VISIT. THE SITE BELIEVES THE ERM CONTRIBUTED TO THE LOWER-THAN-EXPECTED VISUAL ACUITY IN THIS EYE. THE SUBJECT REPORTED THAT THE VISUAL SYMPTOMS DID SIGNIFICANTLY INTERFERE WITH HER DAILY ACTIVITIES, AND MENTIONED DRIVING AND READING IN THE PATIENT REPORTED VISUAL SYMPTOM QUESTION

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9236621 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 19.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. THE LENS WAS EXPLANTED BECAUSE THE PATIENT EXPERIENCED VISUAL DISTURBANCES, INCLUDING BEING UNABLE TO FOCUS AND READ UP CLOSE. REPORTEDLY, THE SYMPTOMS SIGNIFICANTLY INTERFERED WITH THE PATIENT'S DAILY ACTIVITIES. THERE WAS NO INCISION ENLARGEMENT PERFORMED AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS A ZXT300 17.5 DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances; Visual Impairment

  MAUDE report 7815963 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 19.5 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE DOCTOR OVER-CORRECTED THE PATIENT'S ASTIGMATISM/THE INCORRECT POWER WAS IMPLANTED. THERE WAS NO INCISION ENLARGEMENT AND THE PATIENT HAS RECOVERED. THE REPLACEMENT LENS WAS THE SAME DIOPTER, BUT DIFFERENT MODEL ZXT225. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7671746 ↗