TECNIS IOL ZXT300 (REF ZXT300U210)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474606401), received between Sep 20, 2017 and Jan 14, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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

• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE ZXT300 MODEL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR SINISTER (LEFT EYE). POST-OPERATIVELY, THE PATIENT WAS UNHAPPY WITH OS VISION, UNABLE TO DRIVE AT NIGHT, AND SYMPTOMS HAVE PERSISTED SINCE 2017. FOLLOWED WITH PHOTOREFRACTIVE KERATECTOMY (PRK) TO IMPROVE DISTANCE VISION, (B)(6) 2024. PATIENT WAS STILL UNHAPPY WITH VISION, DISTANCE VISION NOT CLEAR. THE ZXT300 IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPLACED WITH A DRN00V 23.5 DIOPTER IOL. THERE WAS NO INCISION ENLARGEMENT, NO MEDICAL ATTENTION, NO MEDICATION PRESCRIBED (OUTSIDE OF STANDARD CARE), NO PROCEDURAL DELAYS, NO SUTURES, AND NO VITRECTOMY DURING THE LENS EXCHANGE PROCEDURE. BEST CORRECTED VISUAL ACUITY POST-OPERATIVE WAS REPORTED AS 20/20+2; PATIENT STATUS POST LENS EXCHANGE IS UNKNOWN. THE IOL DIRECTIONS FOR USE WERE FOLLOWED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Blurred Vision; Discomfort; Visual Disturbances

  MAUDE report 21154631 ↗
• InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT COMPLAINED OF BLURRY VISION AT NEAR AND EXPERIENCED GLARE WITH AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE. THEREFORE, THE LENS WAS EXPLANTED. A VITRECTOMY, SUTURES, AND A CAPSULAR TENSION RING (CTR) WERE REQUIRED. THERE WAS NO PATIENT INJURY. A NON-JOHNSON & JOHNSON REPLACEMENT LENS WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS HAPPY WITH THE OUTCOME WITH THE USE OF A READING PRESCRIPTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 11371071 ↗
• InjuryJun 17, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXCHANGED DUE TO ROTATION AND GLARE ISSUES PER THE PATIENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO INCISION ENLARGEMENT BUT SUTURES WERE USED, WHICH ARE NOT PART OF STANDARD PROCEDURE. ADDITIONALLY, IT WAS REPORTED THAT THE IOL WAS FOUND TO HAVE ROTATED FROM 135 AT INITIAL PLACEMENT TO 180 DEGREES. THERE WERE NO INJURES AND NO ADDITIONAL PROCEDURES PERFORMED. THE PATIENT IS DOING FINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8706224 ↗
• InjuryJun 7, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ORIENTATION OF THE INTRAOCULAR LENS (IOL) AT IMPLANTATION IN THE LEFT EYE WAS 011 DEGREES. AT THE 1-MONTH FOLLOW-UP VISIT, THE ORIENTATION OF THE IOL WAS NOTED AS BEING 23 DEGREES. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION WAS RECEIVED; WHERE THE PATIENT COMPLAINED OF BLURRY VISION, DRYNESS, AND THE IOL HAS BEEN REPOSITIONED. THERE WAS NO INCISION ENLARGEMENT, NO INJURY AND NO ADDITIONAL MEDICAL OR SURGICAL PROCEDURES REQUIRED DURING THE REPOSITIONING. FOLLOWING THE REPOSITIONING OF THE IOL, THE PATIENT CONTINUES TO COMPLAIN OF BLURRY VISION BUT THE IOL APPEARS TO BE ON THE INTENDED AXIS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Dry Eye(s); No Code Available

  MAUDE report 8680374 ↗
• InjuryOct 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT300 21.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED AND EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 7988302 ↗
• InjuryOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 21.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT EXPERIENCED BLURRY VISION, CAME OUT WITH 2.00 ASTIGMATISM, AND BECAUSE OF A REFRACTIVE ERROR. REPORTEDLY, THE PATIENT'S PRE-OPERATIVE UNCORRECTED VISUAL ACUITY (VA) WAS 20/80 AND THEIR PRE-OPERATIVE CORRECTED VA WAS 20/40-1. ALSO, THE PATIENT'S POST-OPERATIVE UNCORRECTED VA WAS 20/60 AND THE POST-OPERATIVELY CORRECTED VA WAS 20/20-2 WITH A REFRACTION OF -0.75 X -1.75 X 17. THERE WAS AN INCISION ENLARGEMENT PERFORMED, BUT NO VITRECTOMY OR SUTURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7985894 ↗
• InjurySep 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMPHONY TORIC INTRAOCULAR LENS (MODEL ZXT300, +21.0 DIOPTER) WAS IMPLANTED IN THE LEFT EYE OF A (B)(6) YEAR-OLD MALE PATIENT ON (B)(6) 2017. REPORTEDLY, THE LENS WAS REPOSITIONED ON (B)(6) 2017. THE LENS WAS THEN EXPLANTED ON (B)(6) 2017 AND REPLACED WITH A MULTIFOCAL LENS (MODEL ZLB00, +21.0 DIOPTER). THE MULTIFOCAL ZLB00 LENS WAS ALSO EXPLANTED ON (B)(6) 2017 AND REPLACED WITH A THIRD LENS (MODEL ZCT300, +20.5 DIOPTER). THE EXPLANTED LENSES WERE DISPOSED OF BY THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. THIS MDR IS TO RECORD THE LENS ZXT300. A SEPARATE REPORT WILL BE FILED FOR THE SECOND EXPLANTED LENS, MULTIFOCAL ZLB00.

  Patient problems: No Code Available

  MAUDE report 6881680 ↗