TECNIS IOL ZXT375 (REF ZXT375U100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606777), received between Dec 19, 2016 and Jan 17, 2018 — classified as 2 injuries, 1 malfunction.

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. 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.

• InjuryJan 17, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT375 10.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. THE SURGEON HAD PLANNED TO REPOSITION THE LENS THAT ROTATED 20 DEGREES THREE APPROXIMATELY (3) WEEKS AFTER THE CATARACT SURGERY. THE PATIENT IS NOT COMPLAINING BUT DISTANCE VISION IS 20/60. THE SURGEON INDICATED THAT THE REPOSITIONING PROCEDURE DID NOT TAKE PLACE AT THEIR CENTER BUT WAS DONE AND THAT THE PATIENT IS HAPPY AND DOING FINE. THERE WAS NO INCISION ENLARGEMENT, NO PATIENT INJURIES AND NO ADDITIONAL MEDICAL OR SURGICAL PROCEDURES REQUIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7201933 ↗
• InjuryOct 24, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT375 10.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE LENS ROTATED FROM 95 DEGREES TO 81 DEGREES FROM THE PATIENT'S ONE DAY POST-OPERATIVE DOCTOR'S VISIT TO THEIR ONE MONTH FOLLOW UP VISIT. ALSO, THE PATIENT COMPLAINED OF BLURRY VISION, DIFFICULTY READING, AND INTERFERENCE WITH DAILY ACTIVITIES. IN ADDITION, THE DOCTOR STATES THE PATIENT'S EYE ANATOMY WAS AN ATTRIBUTE TO THE PRODUCT ISSUE (AXIAL LENGTH 26.98). THERE WAS NO POST-OPERATIVE PATIENT INJURY. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 10.5 BECAUSE THEY DID NOT HAVE THE ORIGINAL 10.0 DIOPTER IN STOCK. THE 10.5D ZXT375 WAS PLACED AT 99° WITH A CAPSULAR TENSION RING. ON POST OP DAY #1 LENS WAS AT 99°, UCVA (UNCORRECTED VISUAL ACUITY) WAS 20/32- WITH 2+ CELLS AND NON-CLINICALLY SIGNIFICANT CORNEAL PUNCTATE DEFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6973807 ↗
• MalfunctionDec 19, 2016Torn Material; Torn Material

  THE INTRAOCULAR LENS (IOL) WAS IMPLANTED. ONCE IN THE EYE, THE SURGEON NOTICED A CRACK IN THE LENS. THE LENS WAS THEN REMOVED. ANOTHER LENS WAS THEN IMPLANTED SUCCESSFULLY. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6187299 ↗