TECNIS IOL ZXT225 (REF ZXT225U140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474605671), received between Aug 10, 2017 and Sep 15, 2020 — classified as 8 injuries.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE). THE IOL WAS EXPLANTED DUE TO COMPLAINTS OF DYSPHOTOPSIA. THERE WAS NO PATIENT INJURY, AND NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. PATIENT STATUS POST-OP WAS REPORTED AS FINE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING A NON-JJSV LENS WAS IMPLANTED AS THE REPLACEMENT LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 10533414 ↗
• InjuryJun 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED BILATERAL IMPLANTS BUT SHE CAN¿T SEE UP CLOSE, INTERMEDIATE ITEMS, SEES HALOS & CAN¿T DRIVE AT NIGHT. IT WAS LEARNED THAT SHE ALSO HAS GLARES. THE PATIENT IS SO UPSET BECAUSE HER VISUAL CONCERNS HAVE BEEN GOING ON SINCE AROUND THE BEGINNING OF IMPLANTING OF THE INTRAOCULAR LENSES (IOLS) UNTIL NOW. THE PATIENT CLAIMS THAT THE SYMPTOMS SIGNIFICANTLY INTERFERE WITH HER REGULAR ACTIVITIES. SHE FOUND ANOTHER DOCTOR WHO EXPLANTED HER IOL FROM HER RIGHT EYE (OD). THE DOCTOR WANTS TO WAIT SO SEE HOW THE PATIENT DOES BEFORE POTENTIALLY EXPLANTING THE LENS IN THE OTHER EYE. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE OD. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Halo; No Code Available

  MAUDE report 10202049 ↗
• InjuryJun 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DOCTOR REPORTED AN INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT OPERATIVE EYE. THE LENS WAS LATER EXPLANTED AND REPLACED WITH A ZXT150, 19.5 DIOPTER IOL DUE TO BLURRY VISION AT 1 DAY POST-OP. THE DOCTOR REVEALED THAT THE PATIENT HAS A LOSS OF 2 OR MORE LINES OF BEST CORRECTED VISUAL ACUITY (BSCVA). REPORTEDLY, THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND THE PATIENT IS DOING WELL AFTER DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

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

  MAUDE report 10190915 ↗
• InjuryJan 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A SYMFONY TORIC INTRAOCULAR LENS (IOL) COMPLAINED OF RINGS AND WANTED THE IOL EXPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE IOL WAS EXPLANTED FROM THE RIGHT EYE DUE TO POSITIVE DYSPHOTOPSIA. THERE WERE NO COMPLICATIONS AT THE TIME OF SURGERY. HOWEVER, THE REPLACEMENT LENS WAS FOUND TO BE ROTATED 90 DEGREES (TO 180º INSTEAD OF 90º). THE REPORT CAPTURES THE EVENT FOR THE EXPLANTED IOL. THE REPORT FOR THE ROTATION OF THE REPLACEMENT LENS IS BEING SUBMITTED IN A SEPARATE MDR.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9604686 ↗
• InjuryMay 22, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT COMPLAINED ONE DAY POST-OP THAT HE COULD NOT SEE. THE DOCTOR FOUND THAT THE INTRAOCULAR LENS (IOL) HAD ROTATED. THE LENS WAS ROTATED IN A SECONDARY PROCEDURE TO CORRECT ROTATION. ALL WENT WELL AND THE PATIENT IS DOING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8634602 ↗
• InjuryDec 4, 2017Invalid Sensing; Invalid Sensing

  THE SURGERY CENTER REPORTED THAT A FEMALE PATIENT'S EYE WAS IMPLANTED WITH TECNIS SYMPHONY TORIC INTRAOCULAR LENS (IOL) ON (B)(6) 2017. IT WAS REPORTED THAT PATIENT WAS NOT HAPPY AND DOCTOR WAS PLANNING AN EXPLANT. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS CONFIRMED THAT THE EXPLANT WAS PERFORMED ON (B)(6) 2017. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7080929 ↗
• 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 14.0 DIOPTER IOL WAS IMPLANTED INTO THE LEFT EYE (OS) 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 LEFT EYE. A SEPARATE REPORT WILL BE FILED FOR THE RIGHT EYE

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

  MAUDE report 6854095 ↗
• InjuryAug 10, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED. THE PATIENT WAS -2.00 +2.00 X 153. THE DOCTOR WAS GOING FOR A BIT MORE MYOPIA BECAUSE THE PATIENT WAS HAVING SOME DIFFICULTY WITH READING IN HER FIRST EYE, SO HE AIMED FOR -0.5. THE IOL WAS REPLACED WITH AN IOL OF THE SAME MODEL BUT DIFFERENT DIOPTER. THERE WERE NO COMPLICATIONS DURING THE IOL EXCHANGE. WHEN DISCHARGED, THE PATIENT WAS DOING WELL AND WAS STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6787052 ↗