TECNIS IOL ZXT225 (REF ZXT225U115)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474605626), received between Jun 20, 2018 and Sep 20, 2021 — 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. How this data works · Data updated Oct 13, 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.

• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED REPORT INDICATING THE PATIENT VISITED THEIR DOCTOR AT 6-MONTH POST-OP. THEIR VISUAL ACUITY WAS REPORTED AS FOLLOWS, UNCORRECTED DISTANCE VISUAL ACUITY (UCDVA) FOR THE RIGHT EYE (OD) WAS 20/30 AND FOR THE LEFT EYE (OS) 20/25. THEIR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/20 FOR BOTH EYES (OU). THE PATIENT REPORTED BEING VERY BOTHERED BY HALOS, VERY BOTHERED BY STARBURSTS, MODERATELY BOTHERED WITH SENSITIVITY TO LIGHT, VERY BOTHERED BY GLARE WHILE WORKING ON A COMPUTER AND READING BOOKS. THERE ARE NO PLANS FOR SURGICAL INTERVENTION AND THE PATIENT IS NOT ON ANY MEDICATION OUTSIDE OF THE REGULAR CURRICULUM. HOWEVER, THE SYMPTOMS ARE REPORTED TO BE DEBILITATING TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE LEFT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR THE RIGHT EYE.

  Patient problems: Flashers; Halo; Visual Disturbances

  MAUDE report 12502862 ↗
• InjurySep 10, 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 RIGHT EYE DUE TO PATIENT COMPLAINING OF DYSPHOTOPSIA. THERE WAS NO VITRECTOMY, INCISION ENLARGEMENT, OR SUTURES REQUIRED. ANOTHER JOHNSON & JOHNSON LENS, DIFFERENT MODEL DIU225 AND LOWER DIOPTER (11.0) WAS IMPLANTED AS A REPLACEMENT. THE PATIENT IS DOING GREAT AND VERY HAPPY POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: Visual Disturbances

  MAUDE report 12451895 ↗
• InjuryJul 19, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE POSTOPERATIVE GLARE AT NIGHT. ORIGINAL SURGERY (B)(6) 2019 WITH IMPLANT OF A ZXT225 TORIC INTRAOCULAR LENS (IOL). THE LENS HAD ROTATED AND WAS REPOSITION (B)(6) 2019. VISUAL ACUITY PRE-OP: 20/200. VISUAL ACUITY POST OP: 20/20-1. POSTOPERATIVE REFRACTION WAS +0.25 +0.50 X 005 20/20. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8809760 ↗
• InjuryMay 13, 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 ON THE LEFT EYE AND THEN LATER REMOVED DUE TO REFRACTIVE SURPRISE. THERE WAS NO PATIENT POST-OP INJURY. PRODUCT WAS DISCARDED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8605830 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED BECAUSE OF AN RESIDUAL REFRACTIVE ERROR, THE PATIENT ENDED UP MYOPIC. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THE PATIENT IS DOING WELL. THE REPLACEMENT LENS WAS THE SAME MODEL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8453714 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE ZXT225 +11.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2018. REPORTEDLY, THE PATIENT WANTED MORE NEAR VISION, THEREFORE THE SURGEON EXPLANTED THE LENS ON (B)(6) 2018 AND IMPLANTED A ZXT225 +12.5 DIOPTER AS A REPLACEMENT. THERE WAS NO WOUND ENLARGEMENT, NO VITRECTOMY AND THE PATIENT WAS REPORTED TO BE OKAY. IT WAS NOTED THAT THE EXPLANTED LENS IS NOT AVAILABLE FOR INSPECTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 8005529 ↗
• InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A CAPSULAR TEAR WHILE A ZXT225 11.5 DIOPTER LENS WAS BEING INSERTED INTO THE OPERATIVE EYE. THE LENS WAS CUT OUT BY THE DOCTOR AND AN ALTERNATIVE LENS WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Capsular Bag Tear

  MAUDE report 7617984 ↗