TECNIS IOL ZXT375 (REF ZXT375U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474606906), received between Jan 17, 2017 and Jan 23, 2020 — classified as 4 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON 2019. IT WAS LATER EXPLANTED ON (B)(6) 2020. REASON FOR THE EXCHANGE WAS NOT PROVIDED. CUSTOMER ALSO INDICATED THAT THE EXPLANTED LENS WAS CUT IN HALF AND DISPOSED OF AT THE FACILITY. THERE IS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9619786 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT THE 1-MONTH STUDY VISIT THAT THE PATIENT IMPLANTED WITH A MODEL ZXT375 INTRAOCULAR LENS (IOL) IN THE RIGHT EYE COMPLAINED OF STARBURSTS, HALOS AND GLARE WHICH MADE DRIVING DIFFICULT. AT THE 6-MONTH VISIT THE PATIENT REPORTED STILL HAVING STARBURST AND DIFFICULTY DRIVING. THE SYMPTOMS INTERFERE WITH DAILY ACTIVITIES. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IS 20/20. NO INTERVENTION IS PLANNED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8779254 ↗
• InjuryMar 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT375, +16.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE BECAUSE OF PATIENT'S ASTIGMATISM WHICH REQUIRED A HIGHER DIOPTER LENS. REPORTEDLY, THE TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT375, +18.0 DIOPTER) WAS IMPLANTED AS REPLACEMENT LENS FOR THE PATIENT. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7322287 ↗
• InjuryJan 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 16.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO PATIENT CLAIMING THEIR VISION WAS NOT CRISP. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A 16.0 DIOPTER. THERE WAS NO VITRECTOMY OR INCISION ENLARGEMENT REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6256406 ↗