TECNIS IOL ZXT225 (REF ZXT225U220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 05050474605831), received between Feb 22, 2017 and May 14, 2021 — 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2021Unstable; Unstable

  THE SURGERY CENTER REPORTED OF A 10-DEGREE ROTATION OF AN INTRAOCULAR LENS (IOL) IN THE RIGHT EYE OF A PATIENT IN AN UNMASKED CLINICAL STUDY. NO REPOSITIONING OF THE IOL HAS BEEN PERFORMED AND NO INTERVENTION IS PLANNED. THE VISUAL SYMPTOMS REPORTED ON BOTH EYES OF THE PATIENT. REPORTEDLY, THE SYMPTOMS SIGNIFICANTLY IMPACT THE PATIENT¿S DAILY ACTIVITIES. THERE WERE NO SURGICAL INTERVENTIONS SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES REQUIRED. THERE WAS NO PATIENT INJURY REPORTED. PREOPERATIVE VISIT: ON (B)(6) 2020, VISUAL ACUITY: UCDVA FOR RIGHT EYE (OD) 20/150 AND FOR LEFT EYE (OS) 20/30; BCDVA OD 20/50, OS 20/25. 1 WEEK STUDY VISIT: ON (B)(6) 2020 - RIGHT EYE. IMPLANT WAS PLACED AT 102 DEGREES AND REPORTED AT 92 DEGREES DURING THE 1-WEEK VISIT. THERE WAS NO INTERVENTION REPORTED. 1 MONTH STUDY VISIT: ON (B)(6) 2021: UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) FOR BOTH EYES (OU): 20/20; BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA FOR BOTH EYES (OU): 20/20. THE SUBJECT REPORTED OF BEING MODERATELY BOTHERED BY HALOS; READING COMPUTER SCREEN BRIGHT LIGHTS (INDOOR/OUTDOOR) CAUSE FATIGUE/MILD HEADACHES; MODERATELY BOTHERED BY STARBURSTS-DRIVING; VERY BOTHERED BY SENSITIVITY TO

  Patient problems: Blurred Vision; Flashers; Halo; Headache; Visual Disturbances

  MAUDE report 11828462 ↗
• InjuryFeb 5, 2020Adverse 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) 2020 DUE TO UNEXPECTED POST-OP REFRACTION. THE PATIENT COMPLAINED OF EXPERIENCING VISUAL DISTURBANCE, HALO AND STARBURSTS, AND WAS UNABLE TO DRIVE SAFELY. THE OUTCOME WAS NOTED TO SIGNIFICANTLY INTERFERE WITH DAILY ACTIVITIES. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT LOWER DIOPTER. AT EXCHANGE, THERE WAS NO INCISION ENLARGEMENT AND NO INJURY REPORTED. THE CURRENT PATIENT STATUS WAS REPORTED AS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 9674181 ↗
• InjuryJul 9, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZXT225 22.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. HOWEVER, A PLANNED EXPLANT OF THE LENS IS SCHEDULED FOR (B)(6) 2018, BECAUSE THE PATIENT IS DISSATISFIED, INTOLERANT OF IMAGES AT NIGHT, AND BECAUSE THE LENS DECENTERED. REPORTEDLY, THE DOCTOR AND PATIENT HAVE TRIED EVERYTHING, BUT THE PATIENT IS STILL MISERABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7672102 ↗
• InjuryAug 22, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 22.0 DIOPTER, WAS EXPLANTED FROM THE PATIENT'S LEFT EYE. IN ADDITION, IT WAS REPORTED THAT THE PATIENT EXPERIENCED VISUAL DISTURBANCES AND AN EXPLANT WAS PERFORMED ON (B)(6) 2017. THE REPLACEMENT LENS WAS A ZXT225 23.5 DIOPTER AND THERE WAS NO INCISION ENLARGEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6812450 ↗
• InjuryAug 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN EXPLANT OF A TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL), MODEL ZXT225 22.0 DIOPTER DUE TO A MYOPIC OUTCOME. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6806230 ↗
• InjuryAug 2, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 22.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT EXPERIENCING NIGHT TIME GLARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6762647 ↗
• InjuryMay 3, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT PATIENT UNDERWENT AN IMPLANTATION OF A ZXT225 22.0 DIOPTER TECNIS SYMFONY TORIC INTRAOCULAR LENS (IOL) ON (B)(6) 2017. THE PATIENT PRESENTED POST OP WITH THE LENS OFF CENTER AND EXPERIENCING VISUAL DISTURBANCE. SURGEON SCHEDULED TO PERFORM AN IOL EXPLANT ON (B)(6) 2017. FURTHER INFORMATION WAS PROVIDED IN FOLLOW UP WITH THE SURGERY CENTER. IT WAS LEARNED THE LENS WAS ON AXIS, JUST DECENTERED (NO ROTATION NOTED). THE AFFECTED EYE IS THE LEFT EYE. THE LENS WAS EXPLANTED AND AN INCISION ENLARGEMENT AND ONE SUTURE WERE REQUIRED, THERE WAS NO VITRECTOMY PERFORMED. THE REPLACEMENT LENS WAS ANOTHER ZCT225 OF A HIGHER DIOPTER (23.5).

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6542879 ↗
• InjuryFeb 22, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT225 22.0 INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT EXPERIENCING STARBURSTS AND POOR VISION. THE PATIENT'S PRIMARY COMPLAINT IS DYSPHOTOPSIA AT NIGHT TIME. THE PRESCRIBED GLASSES DID NOT RESOLVE THE GLARE AND STARBURSTS. THERE WAS NO INCISION ENLARGEMENT OR NO VITRECTOMY REQUIRED. ADDITIONALLY, NO FEMTO OR ORA (OCULAR RESPONSE ANALYZER) WAS USED. THE PATIENT'S LEFT EYE IS DOMINANT. REFRACTION IS PLANO +0.50 X 165 ADD +1.50. THE PHYSICIAN NOTED THAT THERE WAS NO PRODUCT QUALITY OR PATIENT ANATOMY ISSUE. THE EXPLANTED ZXT225 LENS WAS REPLACED WITH A ZCT225 22.5 DIOPTER IOL. THROUGH FOLLOW-UP IT WAS LEARNED THAT THE PATIENT IS NOW HAPPY WITH ONLY THE LEFT EYE SYMPHONY EXCHANGE. PATIENT DOES NOT WANT OR NEED TO HAVE HIS RIGHT SYMPHONY LENS EXCHANGED. PATIENT NOW HAS A MINIMONOVISION FOR INTERMEDIATE AND IMPROVED NIGHT TIME DYSPHOTOPSIA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6348354 ↗