TECNIS IOL ZXT375 (REF ZXT375U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474606883), received between Mar 12, 2019 and Jun 27, 2019 — classified as 3 injuries.

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.

• InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT375 +15.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE THE PATIENT WAS OVER REFRACTED, AND EXPERIENCING SPECIFIC VISUAL ISSUES. AT EXPLANT, THE INCISION WAS ENLARGED, AND SUTURES WERE PLACED. ANOTHER LENS, A MODEL ZLB00 +15.0 DIOPTER WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. PATIENT WAS REPORTED STABLE AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8738343 ↗
• InjuryMay 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD BILATERAL IMPLANTS ON (B)(6) 2018. A ZXT375 15.5 DIOPTER WAS IMPLANTED IN THE PATIENT''S LEFT (OS) EYE. APPROXIMATELY A MONTH POST OPERATIVELY, SHE A LASER PROCEDURE WAS PERFORMED ON HER OS, BUT NOT ON THE RIGHT, BECAUSE THE OUTCOME OF THE PROCEDURE DID NOT IMPROVE HER VISION. SHE COMPLAINS OF HALOS AND STARBURSTS THAT INTERFERE WITH HER DRIVING AT NIGHT AND LOOKING AT ANY LIGHTS. HER HEALTHCARE PROVIDER RECOMMENDED THAT SHE SEEK A SECOND OPINION FOR HER VISUAL SYMPTOMS. SHE IS SCHEDULED FOR CONSULTATION ON (B)(6) 2019. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE.

  Patient problems: Halo; No Code Available

  MAUDE report 8571919 ↗
• InjuryMar 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT375 +15.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE IN A SECONDARY PROCEDURE BECAUSE OF RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE REQUIRED. A ZXT375 +14.0 DIOPTER WAS IMPLANTED AS A REPLACEMENT. REPORTEDLY, THE PATIENT WAS DOING GOOD POST LENS EXCHANGE. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED AT THE SURGERY CENTER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8413739 ↗