TECNIS IOL ZXT150 (REF ZXT150U265)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474605336), received between Jul 24, 2017 and Apr 7, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Mechanical Problem” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE FOR UNKNOWN REASON. THE IOL IS NOT RETURNING FOR EVALUATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 16702590 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED AND REPLACED FROM THE PATIENT¿S RIGHT EYE DUE TO PATIENT COMPLAINT OF BLURRY VISION, BECAUSE ASTIGMATISM WAS NOT MANAGED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT LOWER DIOPTER POWER (23.5) IOL. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 10317310 ↗
• InjuryOct 1, 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. THERE WERE NO ISSUES WITH THE LENS EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 9141180 ↗
• InjuryJul 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 26.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019 DUE TO THE PATIENT EXPERIENCING POOR VISUAL ACUITY POST-IMPLANT. THERE IS NO INDICATION THAT INCISION WAS ENLARGED OR THAT SUTURE WAS REQUIRED AT EXPLANT. THE CUSTOMER ALSO INDICATED THAT THE LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8801267 ↗
• InjuryJun 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT150 INTRAOCULAR LENS (IOL) IMPLANTED INTO THE PATIENT'S LEFT EYE WAS EXCHANGED DUE TO PATIENT COMPLAINT OF HALOS AND GLARE. THE EXPLANTED IOL WAS REPLACED WITH A ZCT150 IOL. IT WAS REPORTED THAT AN INCISION ENLARGEMENT AND SUTURES WERE REQUIRED DURING THE EXCHANGE. NO ADDITIONAL INFORMATION WAS PROVIDED. VA PRE-OP: 20/30 BEFORE GLARE; 20/70 WITH GLARE. VA POST-OP: 20/20 +.25.

  Patient problems: Halo; No Code Available

  MAUDE report 8701230 ↗
• InjuryFeb 13, 2019Mechanical Problem; Mechanical Problem

  CUSTOMER REPORTED MECHANICAL COMPLICATION AFTER IMPLANTATION OF MODEL ZXT150 MULTIFOCAL IOL (INTRAOCULAR LENS). THE LENS WAS EXPLANTED ON (B)(6) 2019 AND A REPLACEMENT LENS, MODEL ZXR00 25.0 DIOPTER WAS USED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8336668 ↗
• InjurySep 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 26.50 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT IS EXPERIENCING POOR VISION. AN EXCHANGE OF THE IOL IS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6839967 ↗
• InjuryJul 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A ZXT150 26.5 DIOPTER INTRAOCULAR LENS IS PLANNED TO BE EXPLANTED FROM A PATIENT'S LEFT EYE DUE TO A REFRACTIVE SURPRISE. THERE WAS NO POST-OP INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6738022 ↗