TECNIS IOL ZXT225 (REF ZXT225U125)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474605640), received between Apr 27, 2017 and Feb 19, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2021Unstable; Unstable

  A REPORT WAS RECEIVED FOR A STUDY PATIENT WHO WAS IMPLANTED WITH A TECNIS SYMFONY INTRAOCULAR LENS (IOL). THE SITE HAS NOTED AN AXIS MISALIGNMENT ON (B)(6) 2021, IN THE SUBJECT'S RIGHT EYE (OD). PRE-OPERATIVE BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA): 20/30 RIGHT EYE. IOL AXIS PLACEMENT: 90 AT TIME OF SURGERY. AT ONE-MONTH POST-OP VISIT ON (B)(6) 2021; UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) 20/30, BCDVA 20/25 RIGHT EYE. IOL AXIS PLACEMENT 67 (POST-OP AXIS). NO INTERVENTION PLANNED AT THIS TIME, THE SUBJECT IS SATISFIED WITH THEIR VISION CURRENTLY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11347095 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO RESIDUAL ASTIGMATISM AT 1-DAY POST OPERATION. THE PATIENT OUTCOME (BEST CORRECTED VISUAL ACUITY) WAS REPORTED AS 20/20 WITH -1.25 CORRECTION. THE REPLACEMENT LENS IS A ZXT375, 12.5 DIOPTER IOL. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION PERFORMED DURING THE SECONDARY PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10248928 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT IS EXPERIENCING ISSUES WITH BILATERAL SYMFONY LENSES, HENCE THE SURGEON IS PLANNING ON BILATERAL EXPLANT IN A SECONDARY SURGICAL PROCEDURE. HOWEVER, THE EXPLANT HAS NOT YET BEEN CONFIRMED. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S LEFT EYE. A SEPARATE REPORT IS BEING SUBMITTED FOR PATIENT¿S RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8657056 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT225, +12.5 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE IN A SECONDARY PROCEDURE BECAUSE OF PATIENT EXPERIENCING VISUAL DISTURBANCE AND MILD POSTERIOR CAPSULE OPACIFICATION, PCO. ALSO REPORTED WAS ANISOCORIA - RIGHT PUPIL IS LARGER IN DARK AND LIGHT AND SHE NOTICED THIS AROUND EARLY (B)(6) 2017. ANOTHER MANUFACTURER'S MONOFOCAL LENS WAS USED AS THE REPLACEMENT LENS FOR THE PATIENT. REPORTEDLY PATIENT IS EXPERIENCING HALOS WITH THIS REPLACEMENT LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7405366 ↗
• InjurySep 8, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A DOCTOR NOTICED GLISTENING ON SYMFONY INTRAOCULAR LENSES (IOL) THAT HE HAD BILATERALLY IMPLANTED INTO A PATIENT 6 MONTHS AGO. IN ADDITION, THE PATIENT COMPLAINED OF BLURRY VISION AND FLASHING OF LIGHTS. A ZXT225 12.5 DIOPTER IOL WAS IMPLANTED INTO THE RIGHT EYE (OD) ON (B)(6) 2017. REPORTEDLY, THE SURGEON IS CONSIDERING AN EXPLANT IN THE NEXT FEW MONTHS, BUT IT WAS NOT SPECIFIED WHICH EYE WILL BE EXPLANTED FIRST. THE LENS WILL BE REPLACED WITH A NON-AMO CONVENTIONAL MONOFOCAL IOL. NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT WILL CAPTURE THE LENS IMPLANTED IN THE PATIENT'S RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

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

  MAUDE report 6854100 ↗
• InjuryApr 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 12.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S LEFT EYE AS THE PHYSICIAN DECIDED TO EXCHANGE THE DIOPTER POWER. THE LENS WAS REPLACED WITH THE SAME MODEL LENS WITH A HIGHER DIOPTER POWER (15.5). THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR CAPSULE TEAR REPORTED. FURTHERMORE, THE PATIENT'S DOING WELL. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6526868 ↗