TECNIS IOL ZXT225 (REF ZXT225U120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05050474605633), received between Feb 14, 2018 and Jan 21, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 21, 2019Scratched Material; Scratched Material

  IT WAS REPORTED THAT THE LENS WAS OBSERVED TO BE SCRATCHED WHEN REMOVING FROM PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8265615 ↗
• InjuryOct 30, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT225, 12.0 DIOPTER, INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO LENS ROTATION WHICH LED TO POOR VISION SECONDARY TO INCORRECT ASTIGMATISM. THERE WAS AN INCISION ENLARGEMENT, BUT NO SUTURES OR VITRECTOMY WERE REQUIRED. REPORTEDLY, THE PATIENT IS VERY HAPPY POST-EXPLANT. PRE-OP BEST CORRECTED VISUAL ACUITY (BCVA) WAS 20/40 AND AFTER THE LENS EXCHANGE IT WAS REPORTED TO BE 20/25. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8022487 ↗
• InjuryMar 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. HOWEVER, THERE IS A PLANNED EXPLANT SCHEDULED FOR (B)(6) 2018 DUE TO AN UNEXPECTED POST-OPERATIVE REFRACTION/MYOPIA. REPORTEDLY, THE PATIENT WAS VERY MYOPIC TO BEGIN WITH, THE IOL IS IN PERFECT POSITION, AND THE DOCTOR REPEATED MEASUREMENTS MULTIPLE TIMES. THROUGH FOLLOW UP EXPLANT OF THE LENS WAS CONFIRMED AND THERE WAS NO VITRECTOMY AND NO INCISION ENLARGEMENT REQUIRED, BUT ONE 10.0 NYLON SUTURE WAS PLACED. REPORTEDLY, THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 10.5. THERE WAS NO PATIENT INJURY, BUT THE PATIENT HAD SIGNIFICANT CORNEAL EDEMA AT THEIR ONE DAY POST-OPERATIVE EXAM. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Corneal Edema; No Code Available

  MAUDE report 7375184 ↗
• InjuryFeb 14, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT225 12.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 BECAUSE THE PATIENT DEVELOPED MYOPIA. THERE WAS AN INCISION ENLARGEMENT, BUT THERE WERE NO SUTURES NEEDED. THE REPLACEMENT LENS WAS A MODEL ZXT225 10.0, A SMALLER DIOPTER LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7272120 ↗