TECNIS IOL ZXT150 (REF ZXT150U120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474605046), received between Nov 17, 2017 and Aug 14, 2019 — 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.

• InjuryAug 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUMMARY OF REPORTED EVENT: IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT EYE DUE TO INCORRECT POWER IMPLANTED DUE TO DRY EYE, THUS RESIDUAL CYLINDER OCCURRED. ZXT150 EXPLANTED AND EXCHANGED FOR A ZXT300. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8894291 ↗
• InjuryJan 8, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A HIGH MINUS PATIENT WAS IMPLANTED WITH A SYMFONY LENS AND THE OUTCOMES WERE NOT GOOD. ADDITIONAL INFORMATION RECEIVED REVEALED A ZXT150 INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2018, INTO THE PATIENTS LEFT EYE. THE PATIENT HAD RESIDUAL ASTIGMATISM. THE LENS WAS ROTATED ON (B)(6) 2018, AND AN OPTIC CAPTURE WAS PERFORMED ON 10/10/2018. DISTANCE VISION WAS EXCELLENT; PATIENT STRUGGLES WITH INTERMEDIATE/NEAR VISION. PATIENT WAS EVALUATED ON (B)(6) 2018, AND WAS DIAGNOSED WITH PCO (POSTERIOR CAPSULE OPACIFICATION) WHICH WAS NOT SIGNIFICANT ENOUGH TO WARRANT A LASER YAG CAPSULOTOMY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8227851 ↗
• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE (OD) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018, DUE TO HALOS AND GLARE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH A ZCB00. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING BETTER POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7301713 ↗
• InjuryNov 17, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT''S RIGHT EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT COMPLAINED OF HALO AND GLARE, WHICH WERE INTOLERABLE. AT EXPLANT THE INCISION WAS ENLARGED TO 2.75MM. THE LENS WAS REPLACED WITH A SAME MODEL, BUT A DIFFERENT DIOPTER (11.5) IOL. REPORTEDLY, THERE WAS NO PATIENT INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7043359 ↗