TECNIS IOL ZXT300 (REF ZXT300U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474606364), received between Mar 20, 2017 and May 4, 2022 — classified as 6 injuries, 1 malfunction.

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.

• InjuryMay 4, 2022Adverse 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 FROM THE PATIENT¿S RIGHT EYE DUE TO GLARE AND PATIENT NOT BEING HAPPY WITH THE LENS. ACCOUNT INDICATED THAT THE CAPSULE TORE DURING THE PROCEDURE AND A VITRECTOMY WAS PERFORMED. SUTURES WERE REQUIRED TO PREVENT INJURY. INITIALLY, THE PATIENT WAS LEFT APHAKIC. EVENTUALLY, A BAUSCH & LOMB ANTERIOR CHAMBER LENS WAS PLACED AS THE REPLACEMENT IOL. THE HEALTH CARE PROVIDER REPORTED THE SYMPTOMS AS DEBILITATING TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear; No Clinical Signs, Symptoms or Conditions; Visual Disturbances

  MAUDE report 14283380 ↗
• InjurySep 17, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED BY THE CLINICAL SITE THAT AN INTRAOCULAR LENS (IOL) IN THE PATIENT'S RIGHT EYE HAD AN AXIS MISALIGNMENT. THE AXIS PLACEMENT FROM ORIGINAL 56, THEN THE LENS ROTATED TO 35 DEGREES POST-OP. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA): 20/25 RIGHT EYE (OD); 20/40 LEFT EYE (OS). THE IOL REPOSITIONING DID OCCUR LATER ON. IT WAS ALSO LEARNED THAT ON FOLLOW-UP UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/20; ON EXAM THE SUBJECT HAS DRY EYE, TRACE POSTERIOR CAPSULE STRIAE/WRINKLES, MAP DOT FINGERPRINT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Dry Eye(s); Halo; No Code Available

  MAUDE report 10544721 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS INITIALLY REPORTED THAT SURGEON HAD A PATIENT FROM DECEMBER WHO WILL BE HAVING A SYMPHONY EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE LENS WILL BE EXPLANTED FROM PATIENT¿S LEFT EYE BECAUSE OF PATIENT EXPERIENCING INTOLERANCE TO THE LENS AND REQUESTED TO REMOVE THE LENS. PATIENT IS ALSO EXPERIENCING HALOS, GLARE, UNEXPECTED VISUAL SYMPTOMS AND WANTS THE LENS TO BE REPLACED WITH MONOFOCAL LENS. THE EXPLANT IS PENDING DUE TO COVID. THERE HAS BEEN NO PATIENT INJURY, NO SURGICAL OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 10203841 ↗
• InjuryJun 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT300 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OPERATIVE EYE ON (B)(6) 2019. THE LENS WAS EXPLANTED ON (B)(6) 2019 DUE TO COMPLAINT OF HYPEROPIA. IT WAS REPORTED THERE WAS NO REQUIRED MEDICAL INTERVENTION, THE ZXT300 19.0 DIOPTER IOL WAS REPLACED WITH A ZXT300 21.5 (LARGER) DIOPTER LENS, AND PATIENT WAS REPORTED AS WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available

  MAUDE report 8729302 ↗
• MalfunctionSep 3, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE ZXT300 TORIC MULTIFOCAL INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018. THE LENS ORIGINALLY PLACED AT 175 DEGREES WAS MEASURED AT 20 DEGREES ON (B)(6) 2018. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PATIENT WILL BE SEEN AGAIN ON 09/10/2018 FOR RE-MEASUREMENT AND A DECISION WILL BE MADE IF THE LENS WILL BE REPOSITIONED OR IF LASIK (LASER-ASSISTED IN SITU KERATOMILEUSIS) PROCEDURE WILL BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7840726 ↗
• InjuryMay 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SURGEON IS PLANNING TO EXCHANGE A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300, +19.0 DIOPTER) FROM PATIENT¿S OPERATIVE EYE BECAUSE OF THE PATIENT EXPERIENCING BLURRY VISION. THE BLURRY VISION OCCURS WHEN THE PATIENT TILTS THEIR HEAD IN DIFFERENT WAY AT DISTANCE AND ALSO REPORTS HAVING DIFFICULTY SEEING NEAR. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 7549766 ↗
• InjuryMar 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE RIGHT EYE OF A (B)(6) MALE PATIENT. THE SURGEON IS PLANNING TO EXCHANGE THE LENS AS THE PATIENT ENDED UP POST-OP WITH INCREASED CYLINDER OF 3.75 DIOPTERS. PATIENT POST-OP REFRACTION -2.00 + 3.75 X 113. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6416487 ↗