TECNIS IOL ZXT225 (REF ZXT225U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474605893), received between Mar 15, 2018 and Apr 27, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 27, 2021Adverse 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 PATIENT'S LEFT EYE DUE TO MYOPIC MISS. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS (SAME MODEL, BUT LOWER DIOPTER) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING WELL POST-OPERATIVELY AND IS HAPPY WITH VISION. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Impairment

  MAUDE report 11730375 ↗
• InjuryMay 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT AT THE 4TH MONTH VISIT, DEVELOPED HALOS/STARBURSTS AND REPORTS THEY HAVE WORSENED COMPARED TO BEFORE SURGERY. IT WAS STATED THAT PATIENT IS VERY BOTHERED OF THE VISUAL ISSUES, DRIVING AT NIGHT. NEVERTHELESS, THE PREOPERATIVE MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WERE 20/25 FOR RIGHT EYE (OD) AND 20/30 FOR LEFT EYE (OS). AT 4TH MONTH VISIT, VISUAL ACUITY REPORTED TO BE 20/40 RIGHT EYE (OD), 20/32 LEFT EYE (OS). THERE WAS NO INTERVENTION PLANNED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8580816 ↗
• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT225 INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENT'S LEFT EYE (OS) (B)(6) 2018. REPORTEDLY, THE PATIENT WAS HAVING TROUBLE FUNCTIONING DUE TO THE HALOS AND GLARE. HER SYMPTOMS WERE FIRST REPORTED (B)(6). THERE WAS NO PATIENT INJURY REPORTED AND THE PATIENT WAS DOING FINE POST SURGERY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7774621 ↗
• InjuryJul 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY, THE PHYSICIAN PERFORMED CATARACT SURGERY ON (B)(6) 2017 ON PATIENT'S EYE. THE PHYSICIAN IMPLANTED SYMFONY TORIC MULTIFOCAL LENSES. AFTER THE INITIAL SURGERY, PATIENT DID EXPERIENCE GLARING HALOS AND WAS UNABLE TO DRIVE A CAR. PRIOR TO SURGERY, PATIENT WAS NOT AWARE THAT THESE SYMPTOMS WOULD OCCUR. CONSEQUENTLY, OTHER PHYSICIAN EXPLANTED HER MULTIFOCAL LENSES ON (B)(6) 2017. THE PHYSICIAN IMPLANTED PATIENT'S RIGHT EYE (OD) DUE TO A STIGMATISM, WHILE THE OTHER LEFT EYE (OS) WAS IMPLANTED WITH STANDARD LENS. PER FOLLOW-UP, THE PATIENT DID NOT RECALL WHICH EYE WAS EXPLANTED FIRST AND STATED THAT THE PROBLEMS STARTED IMMEDIATELY, BUT COULD NOT PROVIDE AN EXACT DATE. THE PATIENT MENTIONED HER SYMPTOMS TO THE DOCTOR. AND SHE WAS ADVISED TO WAIT FOR HER EYES TO ADAPT. PATIENT WAS ALSO PRESCRIBED GLASSES BY HER DOCTOR, BUT DIDN¿T HELP. MOREOVER, THE SYMPTOMS WERE SO BAD THAT THEY AFFECT HER ABILITY TO DRIVE. IT WAS STATED THAT THERE WAS NO PATIENT INJURY HOWEVER. NO ADDITIONAL INFORMATION PROVIDED. THIS REPORT PERTAINS TO LEFT EYE (OS). A SEPARATE REPORT HAS BEEN SUBMITTED TO RIGHT EYE (OD).

  Patient problems: Halo; No Code Available

  MAUDE report 7656176 ↗
• InjuryMar 15, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT A ZXT225 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED BECAUSE OF SUBLUXATION OF THE LENS. THE REPLACEMENT LENS WAS A SINGLE-FOCUS 3-PIECE IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7343280 ↗