TECNIS IOL ZXT150 (REF ZXT150U245)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474605299), received between Oct 18, 2017 and Feb 12, 2020 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT¿S LEFT EYE DUE TO NIGHT DYSPHOTOPSIAS. AT EXPLANT, THERE WAS NO CAPSULE TEAR. THE PATIENT OUTCOME WAS REPORTED AS EVERYTHING LOOKS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 9697343 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE DUE TO RESIDUAL ASTIGMATISM. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY REPORTED. PATIENT IS REPORTED TO BE DOING FINE POST EXPLANT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8538630 ↗
• InjuryNov 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150, 24.5 DIOPTER INTRAOCULAR LENS (IOL), WAS EXPLANTED FROM A PATIENT¿S LEFT EYE (OS) DUE TO NIGHT GLARE ISSUES WHICH INTERFERED WITH DRIVING. IT WAS INDICATED THAT THE IOL WAS WELL CENTERED AND THE SURGERY WAS UNCOMPLICATED. THE PATIENT HAD GREAT DAYTIME VISION AND WAS VERY PLEASED IT, DISTANCE AND NEAR. HOWEVER, SHE WAS UNABLE TO SAFELY DRIVE AT NIGHT TIME WHICH INTERFERED WITH HER WORK AS SHE SOMETIMES WOULD NEED TO DRIVE AT NIGHT. THERE WAS AN INCISION ENLARGEMENT IN ORDER TO EXPLANT THE LENS. A REPLACEMENT LENS, ZCT150 WITH THE SAME DIOPTER WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8031306 ↗
• InjuryOct 20, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150, 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE (OD) DUE TO REFRACTIVE ERROR SINCE THE WRONG LENS WAS CHOSEN BY THE DOCTOR. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES DONE. THE PATIENT IS DOING WELL POST-EXPLANT. A REPLACEMENT LENS OF THE SAME MODEL BUT DIFFERENT DIOPTER (22.5 DIOPTER) WAS USED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7987825 ↗
• InjuryMay 17, 2018Adverse 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 ZXT150, +24.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING HEADACHES DUE TO HALOS. THE LENS WAS REPLACED WITH MODEL Z9003, +23.5 DIOPTER. REPORTEDLY THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY. PATIENT WAS OK AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; Headache; No Code Available

  MAUDE report 7521097 ↗
• InjuryOct 18, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT150 24.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. THE LENS WAS IMPLANTED AT 85 DEGREES AT POD#1 (POST-OP DAY 1) THE LENS WAS AT 67 DEGREES. THE PATIENT ALSO COMPLAINED OF BLURRY VISION, WHICH INTERFERES WITH DAILY ACTIVITIES. NO ADDITIONAL INFORMATION WAS PROVIDED. THE LENS WAS REPOSITIONED WITH AND A NON-AMO CAPSULAR TENSION RING WAS PLACED ON (B)(6) 2017. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6960602 ↗