TECNIS IOL ZXT150 (REF ZXT150U295)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 05050474605398), received between Feb 3, 2017 and Sep 20, 2019 — classified as 2 injuries, 1 malfunction.

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.

• InjurySep 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MODEL ZXT150, 29.5 DIOPTER INTRAOCULAR LENS (IOL) MIGHT BE EXPLANTED FROM THE PATIENT'S OPERATIVE EYE DUE TO THE PATIENT IS UNHAPPY. REPORTEDLY, THE SURGEON HAS DONE ALL HE CAN TO HELP THE PATIENT AND IS THEREFORE, REFERRING THE PATIENT TO ANOTHER SURGEON FOR A POTENTIAL IOL EXCHANGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9100315 ↗
• InjuryApr 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150 +29.5 DIOPTER) WAS EXPLANTED IN SECONDARY PROCEDURE FROM PATIENT¿S LEFT EYE BECAUSE PATIENT WAS EXPERIENCING SPECIFIC VISUAL ISSUES, REPORTED AS 1.74 DIOPTER HYPEROPTICNESS. A MODEL ZXT150 +32.0 DIOPTER WAS USED AS THE REPLACEMENT LENS. THERE WAS NO PATIENT INJURY, NO OTHER SURGICAL OR MEDICAL INTERVENTION AND NO INCISION ENLARGEMENT. PATIENT IS DOING WELL AFTER THE OUTCOME. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8507355 ↗
• MalfunctionFeb 3, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  INITIALLY, IT WAS REPORTED THAT THE PATIENT WAS NOT HAPPY WITH DISTANT VISION. AFTER THE IMPLANTATION OF THE SYMFONY LENSES, PATIENT EXPERIENCED HALOS AND STARBURST ON THE SIDES, IN ALL LIGHTS. ADDITIONAL INFORMATION INDICATED THAT THE PHYSICIAN IS EVALUATING PATIENT SYMPTOMS AND HOPES THAT THE SOLUTION WILL SIMPLY BE A LASIK TOUCH UP FOR THE MINOR REFRACTIVE ERROR ON BOTH EYES. FURTHER INFORMATION REPORTED THAT NO EXPLANT AT THIS TIME, PATIENT IS WEARING CORRECTIVE LENSES FOR FINE TUNING DISTANCE VISION. HOWEVER, PATIENT WILL PROBABLY NEED LASIK TOUCH. THE PHYSICIAN REPORTED PATIENT WAS AT 3 WEEKS POST OP ON (B)(6) 2016, AND FEELS BETTER WITH DARKER GLASSES. PATIENT DOES NOT HAVE ANY CORNEAL CHANGES OR DRY EYES. PATIENT HAS -0.75D OF RESIDUAL ASTIGMATISM IN BOTH EYES. FURTHERMORE, THE PHYSICIAN INDICATED THAT THE LENS HAS A CLOUDY CENTRAL AREA. DOCTOR WAS QUESTIONING IF THE LATHE LINES THAT HE SAW AT THE CENTRAL, 0.75MM OF THE SYMFONY LENS COULD CAUSE MYOPIA. REPORTEDLY, AT THIS TIME, PATIENT DID NOT WANT ANY INTERVENTION PERFORMED AND IS CONTENT WITH WEARING GLASSES. THIS REPORT WILL CAPTURE ZXT150 LENS IMPLANTED ON THE RIGHT EYE. A SEPARATE MDR REPORT WILL BE FILED FOR THE LENS

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 6302678 ↗