TECNIS IOL ZXT375 (REF ZXT375U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606951), received between Jan 10, 2017 and Jul 19, 2019 — classified as 3 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 16, 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.

• InjuryJul 19, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT375 19.0 DIOPTER LENS ROTATED 60 DEGREES COUNTER CLOCKWISE RESULTING IN HIGH ASTIGMATISM. INITIALLY THE DOCTOR THOUGHT OF RE-ROTATING THE LENS AND SEE HOW THE PATIENT DOES BEFORE EXCHANGING IT. HOWEVER, THE DOCTOR DECIDED TO EXPLANT THE LENS. THE PATIENT IS UNABLE TO TOLERATE SPECTACLE CORRECTION DUE TO THE DISTORTION. VIA FOLLOW-UP THE CUSTOMER CONFIRMED THAT THE EXPLANT IS PLANNED FOR (B)(6) 2019 DUE TO THE ROTATION AND HIGH ASTIGMATISM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8809820 ↗
• InjuryJul 26, 2017Unintended Movement; Appropriate Device Problem Term/Code Not Available; Unintended Movement; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXT375 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. THE PATIENT HAD 3.23D OF ASTIGMATISM AND AT (B)(6) 2017 THE PATIENT IS 2200 AT DISTANCE WITH 4.5D OF ASTIGMATISM. THE DOCTOR BELIEVES THERE WAS NO CYLINDER CORRECTION IN THE LENS AND WOULD LIKE TO EXCHANGE IT FOR THE EXACT SAME LENS. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PHYSICIAN DECIDED NOT TO EXPLANT THE LENS BUT TO ROTATE THE IOL INSTEAD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6745518 ↗
• InjuryJan 10, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED IN A SECONDARY PROCEDURE. REPLACEMENT PLANNED WITH A NON TORIC SYMFONY LENS WITH THE SAME POWER. REPORTEDLY, THE SPHERICAL EQUIVALENT POST OP, DIAGNOSTIC REFRACTION, IS PLANO BUT THE AXIS OF THE CYLINDER IS ALMOST 90 DEGREES OFF. ALL MEASUREMENTS AND TOPOGRAPHY WERE REPEATED AND REMAIN THE SAME AS ORIGINAL. CYLINDER WILL HAVE TO BE READDRESSED POST OP. FURTHER INFORMATION REPORTS THEY DID NOT REPOSITION THE LENS AS THERE WAS TRULY NO ROTATION. THEY JUST PROCEEDED TO LENS EXPLANT. NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE, NO PATIENT POST-OP INJURY. THE PATIENT'S RECORDS WERE PROVIDED AND REPORTS THE FOLLOWING: PATIENT'S IMPLANT SURGERY ON THE RIGHT EYE WAS (B)(6) 2016. POST OP DAY ONE, (B)(6) 2016: SLIGHT BLURRY TODAY WITH COMPLAINT OF HALOS AROUND LIGHTS. VISUAL ACUITY 20/25 +2 SC (SANS CORRECTED) VISUAL ACUITY 20/25 SLIT LAMP EXAM (SLE) SHOWED MILD EDEMA AND TRACE CELLS. POST OP, (B)(6) 2016: VISUAL ACUITY 20/40; VISUAL ACUITY 20/25. LENS EXPLANTED (B)(6) 2016 FROM THE RIGHT EYE POST OP (OF LENS EXPLANT) ON (B)(6) 2016 COMPLAINT OF FILM OVER RIGHT EYE AND HALOS VISUAL ACUITY 20/20 -2 (SC) SANS CORRECTED V

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 6235865 ↗