TECNIS IOL ZXT375 (REF ZXT375U205)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606982), received between May 1, 2018 and Dec 18, 2019 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MODERATE GLARE AND HALOS WHILE DRIVING AT NIGHT. IN THE NON-DIRECTED OCULAR VISUAL SYMPTOMS, THE SUBJECT HAD NO COMPLAINTS. THE MONOCULAR (UNCORRECTED DISTANCE VISUAL ACUITY) UCDVA - OCULAR DEXTER (OD) 20/20; OCULUS SINISTER (OS) 20/20. MONOCULAR (BEST CORRECTED DISTANCE VISUAL ACUITY) BCDVA ¿ OD 20/20; OS 20/20. THE FIRST EYE OD HAD SURGERY ON (B)(6) 2019 AND WAS IMPLANTED WITH A 20.5 D MODEL ZXT375 IOL, SERIAL NUMBER (B)(4). THE SECOND EYE OS HAD SURGERY ON (B)(6) 2019 AND WAS IMPLANTED WITH A 20.0 D MODEL ZXT225 IOL, SERIAL NUMBER (B)(4). ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT PATIENT HAD REPORTED SAME ISSUES AT 1 MONTH VISIT AS WELL. THERE IS NO SURGICAL INTERVENTION PLANNED. PATIENT¿S DAILY ACTIVITIES ARE SEVERELY AFFECTED. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S RIGHT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9489134 ↗
• MalfunctionDec 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) ROTATED 23 DEGREES. THE PATIENT'S REFRACTION IS -3.00/+2.25. THROUGH FOLLOW UP, THE SURGEON IS WAITING TO SEE IF THE LENS WILL BE REPOSITIONED OR EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9479002 ↗
• InjuryMay 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 20.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS NOT ABLE TO SEE. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME DIOPTER POWER, BUT DIFFERENT MODEL ZXT400. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 7478130 ↗