TECNIS IOL ZXT300 (REF ZXT300U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606487), received between Jul 28, 2017 and Dec 6, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300 +25.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE BECAUSE OF PATIENT EXPERIENCING GLARES. REPORTEDLY PATIENT HAD DEVELOPED ISSUES WITH VISION NOT FOCUSING SINCE CATARACT SURGERY, ANXIETY FROM VISION, POOR VISUAL ACUITY AND CONSTANT FLASHES. LENS WITH MODEL ZCT300 +24.5 DIOPTER WAS USED AS REPLACEMENT FOR THE PATIENT. PATIENT HAS RECOVERED. NO FURTHER INFORMATION PROVIDED.

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

  MAUDE report 9427536 ↗
• InjuryAug 30, 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 EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO A REFRACTIVE MISS. THE EXPLANTED IOL WAS REPLACED WITH A ZXT150 OF A DIFFERENT DIOPTER. ADDITIONAL INFORMATION RECEIVED REVEALED THE PATIENT WAS DIAGNOSED WITH BLURRY VISION. THERE WAS NO ADDITIONAL INTERVENTION PERFORMED AND THE PATIENT WAS DOING WELL POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8949533 ↗
• InjuryJan 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE LEFT EYE (OS) OF THE PATIENT ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, DUE TO GLARE AND BLURRY VISION. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES. THE LENS WAS REPLACED WITH A NON-AMO LENS 23.5 DIOPTER. REPORTEDLY, PATIENT IS DOING FINE POST-OPERATIVELY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7210873 ↗
• InjuryOct 17, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT300 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017 AND ROTATED TO 100 DEGREES FROM THE TARGET DEGREE OF 80, WHICH WAS A DIFFERENCE OF 20 DEGREES. IN ADDITION, THE PATIENT'S POST-OPERATIVE VISUAL ACUITY WAS 20/80 AND SHE COMPLAINED OF BLURRY VISION. THEREFORE, A SECOND SURGERY IS SCHEDULED TO BE PERFORMED ON (B)(6) 2017 TO ROTATE THE LENS BACK TO THE 80 DEGREES. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6956743 ↗
• InjuryJul 28, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A ZXT300 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A MECHANICAL COMPLICATION OF THE IOL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6750960 ↗