TECNIS IOL ZXT300 (REF ZXT300U185)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474606357), received between Jan 24, 2017 and Mar 31, 2021 — classified as 6 injuries, 1 malfunction.

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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO THE UNSPECIFIED VISUAL ISSUES WHICH SIGNIFICANTLY AFFECTED THE PATIENT'S DAILY ACTIVITIES. IT WAS STATED THAT THERE WAS ALSO MEDICATION PRESCRIBED. THERE WAS INCISION ENLARGEMENT, BUT NO VITRECTOMY AND NO SUTURES. IT WAS ALSO LEARNED THAT REPLACEMENT LENS WAS ZXT375, 17.5D, SN OF (B)(4). UPON FURTHER FOLLOW-UP IT WAS NOTED THAT THE SUSPECT PRODUCT WAS DISCARDED. THERE WAS NO PATIENT POST-OP INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Eye Injury

  MAUDE report 11595873 ↗
• InjuryJun 23, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THE INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019 AND LENS WAS MISALIGNED. AT IMPLANT, OD IOL AXIS PLACEMENT WAS 004. AT SIX (06) MONTHS, IT WAS REPORT OD IOL AXIS WAS 15. NO SECONDARY SURGICAL INTERVENTION IS PLANNED AT THIS TIME. AT ONE (01) YEAR STUDY VISIT CLINICAL STUDY VISUAL SYMPTOM QUESTIONNAIRE INDICATES THE PATIENT BEING EXTREMELY BOTHERED BY HALOS AND WILL NOT DRIVE AT NIGHT, EXTREMELY BOTHERED BY STARBURSTS, MODERATELY BOTHERED BY MULTIPLE OR DOUBLE VISION, VERY BOTHERED BY SENSITIVITY TO LIGHT, EXTREMELY BOTHERED BY GLARE RELATED TO SCATTERED LIGHT, VERY BOTHERED BY OCCLUSIONS, EXTREMELY BOTHERED BY POOR LOW LIGHT VISION. VISUAL SYMPTOM QUESTIONNAIRE ALSO INDICATES PATIENT REPORTED THIS IS WRONG PRESCRIPTION LENS. ONE (01) YEAR VISUAL ACUITY (VA) WAS REPORTED AS: OD UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/25 AND OD BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) 20/25. PREOP VA WAS REPORTED AS: OD UCDVA 20/70 AND OD BCDVA 20/40. THE SUBJECT HAS COMPLETED THE STUDY. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT CAPTURES THE IOL IN THE PATIENT'S OCULAR DEXTER (RIGHT EYE). A SEPARATE REPORT WILL BE

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 10182785 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD BLURRED/DISTORTED VISION AND POSSIBLY HAD A INTRAOCULAR LENS (IOL) POWER PROBLEM AS THE OPD (OPTICAL PATH DIFFERENCE) REFRACTION WAS SLIGHTLY OFF IN THE RIGHT EYE. THEREFORE, THE LENS WAS EXPLANTED AND REPLACED WITH ANOTHER MODEL WITH THE SAME DIOPTER BUT DIFFERENT MODEL. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Blurred Vision; No Code Available; Visual Disturbances

  MAUDE report 9154492 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AT THE 1-MONTH STUDY VISIT THAT THE PATIENT IMPLANTED WITH A MODEL ZXT300 INTRAOCULAR LENS (IOL) IN THE LEFT EYE COMPLAINED OF STARBURSTS, HALOS AND GLARE WHICH MADE DRIVING DIFFICULT. AT THE 6-MONTH VISIT THE PATIENT REPORTED STILL HAVING STARBURST AND DIFFICULTY DRIVING. THE SYMPTOMS INTERFERE WITH DAILY ACTIVITIES. BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) IS 20/20. NO INTERVENTION IS PLANNED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8779251 ↗
• InjuryApr 13, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT300 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED ON (B)(6) 2018, BECAUSE THE DOCTOR WANTED TO EXCHANGE THE LENS FOR A SMALLER DIOPTER 16.5 OF THE SAME MODEL LENS. THE REASON FOR THE EXPLANT WAS TO CORRECT THE SPHERE. NO PATIENT DIAGNOSIS WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7431238 ↗
• InjuryMar 8, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEMALE PATIENT COULD NOT TOLERATE THE STARBURSTS AFTER A MODEL ZXT300 18.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED. THEY TRIED NEUROADAPTATION AND DISTANCE SPECTACLES. ADDITIONALLY, THE PHYSICIAN NOTED THAT THE LENS WAS ANATOMICALLY PERFECT, BUT THE PATIENT WAS JUST VERY UNHAPPY, AND WAS UNABLE TO DRIVE SAFELY AT NIGHT. THERE WAS NO PATIENT ANATOMY ISSUE OR A PRODUCT QUALITY ISSUE. PATIENT WAS COMPLAINING AND WANTED A MONOFOCAL TORIC LENS TO REDUCE HER UNWANTED IMAGES AT NIGHT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6390185 ↗
• MalfunctionJan 24, 2017Scratched Material; Scratched Material

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS SCRATCHED DURING INSERTION INTO THE EYE. PATIENT CONTACT WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6274965 ↗