TECNIS IOL ZXT225 (REF ZXT225U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474605695), received between Nov 11, 2016 and Jul 31, 2019 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER IMPLANTATION OF THE ZXT225 INTRAOCULAR LENS (IOL) IN THE PATIENTS RIGHT EYE AND THE REMOVAL OF THE BANDAGES, THE PATIENT COMPLAINED OF BLURRY VISION AT ALL DISTANCES AT ALL TIMES EXCEPT WHEN ILLUMINATED BY BRIGHT WHITE LED LIGHT OR FROM BRIGHT SUNLIGHT OUTDOORS. THIS PROBLEM DID NOT EXIST WITH THE PATIENTS NATURAL LENS. THE PATIENT ALSO REPORTED NOTABLE PHOTIC EFFECTS OF NIGHT VISION MARRED BY EXTREME START-BURSTS EMANATING FROM ALL LIGHT SOURCES AND A BLUISH CAST TO DAYLIGHT SCENES. NO SURGERY RELATED ISSUES HAVE BEEN UNCOVERED IN SUBSEQUENT FOLLOW-UP EXAMS. ADDITIONAL INFORMATION RECEIVED REPORTED THE SYMPTOMS HAVE SIGNIFICANTLY AFFECTED HIS ABILITY TO PERFORM DAILY TASKS SUCH AS DRIVING AT NIGHT. THE SUBJECT IF THERE WERE POTENTIALLY ANY ISSUES WITH THE MANUFACTURING OF THE IOL. THE SUBJECT WAS INFORMED THAT, UPON REVIEW OF THE COMPLAINT IOL, IT WAS DETERMINED THE IOL WAS MANUFACTURED WITHIN SPECIFICATIONS. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 8845948 ↗
• InjuryDec 1, 2017Invalid Sensing; Invalid Sensing

  IT WAS REPORTED THAT LEFT EYE OF A FEMALE PATIENT WAS IMPLANTED WITH INTRAOCULAR LENS (IOL) SYMFONY TORIC 15.0 D ZXT225 ON (B)(6) 2017. AFTER WHICH PATIENT COMPLAINED OF DISABLING NIGHT TIME SYMPTOMS DESCRIBED AS A COBB WEBS FROM HEADLIGHTS AT NIGHT WHICH MAKES HER UNABLE TO DRIVE AT NIGHT. DOCTOR ALSO MENTIONED THAT PATIENT HAS ZXR00 IN THE RIGHT EYE AND HOPES THE PATIENT WOULD NOT NEED AN EXCHANGE OF IOL IN THE RIGHT EYE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT DOCTOR EXPLANTED THE LENS IN LEFT EYE AND REPLACED IT WITH SYMFONY TORIC 14.5D ZCT 225 ON (B)(6) 2017. AN INCISION ENLARGEMENT WAS REQUIRED AND THERE WAS NO PATIENT INJURY REPORTED. THE PATIENT WAS REPORTED FINE AT DISCHARGE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7077166 ↗
• MalfunctionSep 15, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) HAD SHIFTED IN AXIS. DURING FOLLOW UP, IT WAS FOUND THAT THE PATIENT HAD BILATERAL LENS IMPLANTS AND BOTH IOL¿S HAD ROTATED 10 DEGREES EACH. THE DOCTOR IS STILL WAITING FOR THE PATIENT TO GO BACK FOR FOLLOW-UP TO DECIDE ON A PLAN OF ACTION. NO ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT MEDICAL OPTICS. NOTE: 2 MDR¿S WILL BE SUBMITTED, ONE FOR EACH EYE. THIS REPORT CAPTURES THE INFORMATION FOR THE RIGHT EYE.

  Patient problems: No Information

  MAUDE report 6869732 ↗
• InjuryFeb 24, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A PHYSICIAN PERFORMED A LENS EXCHANGE OF A MODEL ZXT225 15.0 DIOPTER INTRAOCULAR LENS (IOL). THE LENS WAS REPLACED WITH A MODEL ZXT150 15.5 DIOPTER DUE TO RESIDUAL CYLINDER. THE PHYSICIAN NOTED THAT THIS ISSUE IS NOT BELIEVED TO BE RELATED TO A LENS FAILURE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6359149 ↗
• InjuryNov 11, 2016Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT PATIENT UNDERWENT INTRAOCULAR LENS IMPLANT IN HIS RIGHT EYE AND WAS EXPERIENCING UNEXPECTED POST OP REFRACTION. THE LENS WAS EXPLANTED. POST OP DAY ONE, DISTANCE VISUAL ACUITY 20/30, J3 NEAR VISION. POST UP WEEK ONE, DISTANCE VISUAL ACUITY 20/40, J7 NEAR VISION. POST OP WEEK THREE, DISTANCE VISUAL ACUITY 20/40, BLURRY, SLOW TO READ, -1.00 + 1.25 X 121, NO NEAR REFRACTION WAS PERFORMED. THE SYMPTOMS HAVE BEEN NOTED TO BE INTERFERING WITH THE ACTIVITIES OF DAILY LIFE FOR THE PATIENT. THE LENS WAS REPLACED WITH A ZCB00 15.5 IOL LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6097047 ↗