Skip to content

TECNIS IOL ZXT375 (REF ZXT375U160)Recalls & reported problems

Johnson & Johnson Surgical Vision, Inc. · TECNIS SYMFONY TORIC ERV 16.0D CYL3.75 · Class 3 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606890), received between May 12, 2017 and Mar 30, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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

Device problems

  • Adverse Event Without Identified Device or Use Problem2
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Code Available2
  • Foreign Body Sensation in Eye1
  • Inflammation1
  • Intraocular Infection1

Recent adverse event reports

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

  • InjuryMar 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT REPORTED THAT A ZXT375 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HER LEFT (OS) EYE ON (B)(6) 2019. AT 1 DAY POST-OPERATION, SHE FELT LIKE THERE WAS SOMETHING IN HER EYE. SHE REPORTED HAVING GLARE AND STREAKS OF LIGHTS COMING THROUGH THE SIDE OF HER VISION. SUBSEQUENTLY, THE PATIENT FOLLOWED UP WITH HER DOCTOR WHERE HE PRESCRIBED DUREZOL AND ILEVRO OPHTHALMIC EYE DROPS TO TREAT PAIN AND INFLAMMATION. HER CURRENT MEDICAL CONDITION IS BEING MONITORED BY HER DOCTOR, AND A RETINA SPECIALIST. HER VISUAL ACUITY HAS IMPROVED AS TIME PASSED. NO FURTHER INFORMATION PROVIDED.

    Patient problems: Foreign Body Sensation in Eye; Inflammation; Intraocular Infection

    MAUDE report 8467878 ↗
  • InjuryOct 5, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

    IT WAS REPORTED THAT A ZXT375 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(4) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO HYPEROPIA AND PRESBYOPIA. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. THERE WAS ALSO NO PATIENT INJURY REPORTED. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 16.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 6915931 ↗
  • InjuryMay 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A ZXT375 16.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE DUE TO A REFRACTIVE MISS. THE LENS WAS REPLACED WITH A ZXT150 IOL WITH A HIGHER DIOPTER SIZE. THE CUSTOMER STATED THAT THE EXCHANGE WAS NOT DUE TO A FAULTY LENS. NO FURTHER INFORMATION WAS PROVIDED.

    Patient problems: No Code Available

    MAUDE report 6565168 ↗

Other Extended depth of focus intraocular lens devices

All Extended depth of focus intraocular lens devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.