TECNIS IOL ZXT300 (REF ZXT300U225)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606432), received between Sep 18, 2017 and Sep 8, 2021 — classified as 5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT THE 6 MONTH UNMASKED STUDY VISIT, THE PATIENT'S VISUAL ACUITY IS UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/25 OD (RIGHT EYE), 20/30 OS (LEFT EYE) AND BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/20 OU (BOTH EYES) WITH THE INTRAOCULAR LENS (IOL). THE PATIENT IS VERY BOTHERED BY HALOS WHILE DRIVING AT NIGHT, EXTREMELY BOTHERED BY MULTIPLE/DOUBLE VISION WHILE DRIVING AND SEEING CLEARLY AT DISTANCE, AND EXTREMELY BOTHERED BY GLARE WHILE DRIVING AFTER DARK. THERE ARE NO PLANS FOR SURGICAL INTERVENTION. MONTH 1 ((B)(6) 2021) VISUAL ACUITY: UCDVA 20/25 OU; BCDVA 20/20 OD, 20/25 OS. PREOPERATIVE ((B)(6) 2021) VISUAL ACUITY: UCDVA 20/50 OD, 20/60 OS; BCDVA 20/25 OD, 20/30 OS. PATIENT HAD BILATERAL LENS IMPLANTS. THIS REPORT CAPTURES THE LENS IMPLANTED IN PATIENTS RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Halo; Visual Disturbances; Visual Impairment

  MAUDE report 12443817 ↗
• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENTS LEFT EYE. THE IOL WAS EXPLANTED BECAUSE THE PATIENT NEEDED A DIFFERENT POWER OF TORIC. THE LENS WAS REPLACED WITH ANOTHER ZXT300 BUT A LOWER DIOPTER (21.0). THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8844499 ↗
• InjuryMay 9, 2019Adverse 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 LEFT EYE DUE TO THE PATIENT EXPERIENCING DYSPHOTOPSIA. THE EXPLANTED LENS WAS REPLACED WITH A NON-JJSV TORIC IOL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Halo; No Code Available

  MAUDE report 8593944 ↗
• InjuryFeb 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 22.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED FROM THE RIGHT EYE (OD) DUE TO PATIENT'S EXPERIENCE OF REFRACTIVE LENS INTOLERANCE, GLARE. THE REPLACEMENT LENS WAS A MODEL ZCT300 23.0 DIOPTER. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR ANY OTHER MEDICAL OR SURGICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. IT WAS INDICATED THAT THE PATIENT WAS HAPPY POST EXCHANGE AND THE SYMPTOMS HAVE RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8356742 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZXT300, +22.5 DIOPTER) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF A REFRACTIVE ERROR. ANOTHER LENS, MODEL ZXT225 +23.5 DIOPTER, WAS IMPLANTED AS A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6874087 ↗