TECNIS IOL ZXT225 (REF ZXT225U175)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474605749), received between Dec 23, 2016 and Mar 25, 2020 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AT A 6-MONTH CLINICAL STUDY VISIT, THE SUBJECT WAS UNHAPPY, COMPLAINED OF NEAR VISUAL ACUITY (VA), BLURRED VA IN THE LEFT EYE (OS) AND REQUESTED FOR THE LENS TO BE EXPLANTED. THE INTRAOCULAR LENS (MODEL ZXT225 17.5 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (18.5) WAS USED. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THE PATIENT¿S OUTCOME AT THE TIME OF DISCHARGE WAS REPORTED TO BE GOOD AND THERE WAS NO PATIENT INJURY. UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) FOR THE LEFT EYE (OS): 20/30, BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) FOR OS: 20/20. PREOPERATIVE VISUAL ACUITY: UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) FOR THE LEFT EYE (OS): 20/80, BEST CORRECTED VISUAL ACUITY (BCVA) FOR OS: 20/20. THE 1-MONTH VISIT WAS ON (B)(6) 2019. MONOCULAR UCDVA ¿ OD: 20/30; OS: 20/30, MONOCULAR BCDVA ¿ OD: 20/25; OS: 20/25 . NO FURTHER INFORMATION WAS REPORTED.

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

  MAUDE report 9878261 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 IOL 17.5 DIOPTER WAS IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE PATIENT COMPLAINED THAT HER VISION IS NOT GOOD. SYMPTOMS SEEM TO SIGNIFICANTLY INTERFERE WITH DAILY LIFE ACTIVITY. THE DOCTOR PERFORMED A YAG (YTTRIUM-ALUMINUM GARNET) PROCEDURE TO HER RIGHT EYE. THRU FOLLOW-UP THE DOCTOR EXPLAINED THAT THE SYMPTOMS ARE GLARE. HE DOES NOT THINK THERE IS ANYTHING WRONG WITH THE IOL AND DOES NOT PLAN ON EXPLANTING IT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9468936 ↗
• InjurySep 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO NOT HAVING GOOD VISION AT DISTANCES AND BAD HALOS POST OPERATIVELY. A REPLACEMENT LENS IS A ZXR00 IOL. THERE IS NO INCISION ENLARGEMENT OR SUTURE REQUIRED. PATIENT OUTCOME IS GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8976122 ↗
• InjuryJun 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT225 17.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE INCORRECT DIOPTER BEING SELECTED. THE EXPLANTED IOL WAS REPLACED WITH THE SAME MODEL IOL OF A HIGHER DIOPTER (19.0). THERE WAS NO INTERVENTION REQUIRED AND THE PATIENT WAS DOING WELL POST-EXCHANGE. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8737660 ↗
• InjurySep 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE RIGHT EYE OF A (B)(6)YEAR-OLD FEMALE PATIENT, DUE TO THE PATIENT COMPLAINING OF SEVERE HALOS AND GLARE. REPORTEDLY, THE PATIENT SUFFERS FROM PRESBYOPIA AND ASTIGMATISM PRE AND POST CATARACT SURGERY. KETOROLAC AND PILICARPINE DROPS WERE APPLIED ALONG WITH A BANDAGE CONTACT LENS (BCL) ON (B)(6) 2017 DURING THE LENS IMPLANT SURGERY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS EXPLANTED AND REPLACED WITH A NON-AMO LENS. THE EXPLANTED LENS WAS DISPOSED OF BY THE CUSTOMER. THE INCISION WAS ENLARGED SLIGHTLY BUT THERE WAS NO LOSS OF VITREOUS. THE PATIENT OUTCOME POST EXPLANTATION WAS REPORTED BEING GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6871265 ↗
• InjuryJun 16, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED BY FEMALE PATIENT THAT A ZXT225 INTRAOCULAR LENS WAS IMPLANTED IN HER RIGHT EYE ON (B)(6) 2016. THE LENS MOVED OUT OF POSITION AND HAD TO BE RE-CENTERED ON (B)(6) 2016, AND THEN ON (B)(6) 2016, IT HAD TO BE SUTURED INTO PLACE. HER BEST VISION IS 20/200 AND EYE GLASSES CANNOT CORRECT ANY FURTHER. SHE REPORTS THAT SHE HAS NO MID OR NEAR RANGE VISION AND SEEMS TO HAVE LOST ALL CONTRAST SENSITIVITY. SHE WAS TOLD THE LENS IS PERFECTLY CENTERED AND THE MACHINES SAY SHE SHOULD SEE GREAT SO THEY (DOCTORS) DO NOT REALLY KNOW WHY SHE EXPERIENCING ISSUES OTHER THAN TO SAY THAT SHE HAS HAD A NUMBER OF SURGERIES, INCLUDING IOL EXCHANGE AND (NOW) THE EYE IS JUST TOO STRESSED TO FUNCTION. HER EYE PRESSURE AFTER EACH SURGERY FELL TO 2MM HG. THE LENS REMAINS IMPLANTED BECAUSE THEY (DOCTORS) ARE TOO AFRAID TO REMOVE IT. PATIENT CLAIMS THAT HER VISION CERTAINLY AFFECTS ALL ACTIVITIES AND BEEN DECLARED LEGALLY BLIND. THIS REPORT IS TO CAPTURE THE 3RD IMPLANTED LENS, TECNIS SYMFONY, THAT HAD TO BE SUTURED IN PLACE AND REMAINS IMPLANTED.

  Patient problems: Intraocular Pressure, Delayed, Uncontrolled; Visual Disturbances; Visual Impairment

  MAUDE report 6649083 ↗
• InjuryDec 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 17.5 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO IOL SURPRISE. LENS WAS REMOVED IN A SECONDARY PROCEDURE AND REPLACED WITH A ANOTHER IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY OR NO PATIENT INJURY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6203326 ↗