TECNIS IOL ZXT225 (REF ZXT225U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474605879), received between Jan 10, 2018 and Sep 30, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• InjurySep 30, 2022Unstable; Unstable

  IT WAS REPORTED POSSIBLE ROTATION OF ZXT225 INTRAOCULAR LENS (IOL) AFTER IMPLANTATION INTO THE PATIENT'S OPERATIVE EYE. THROUGH FOLLOW-UP, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE IOL WAS EXPLANTED DUE TO ROTATION. ZXT225 IOL IS NOT AVAILABLE FOR RETURN AS IT WAS DISCARDED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15515155 ↗
• InjuryMar 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR REPORTED THAT HE REMOVED AN INTRAOCULAR LENS (IOL) FROM A PATIENT'S RIGHT EYE AND REPLACED IT WITH A NON-JOHNSON & JOHNSON LENS. THE REASON FOR THE EXCHANGE WAS DYSPHOTOPSIAS. REPORTEDLY, THERE WAS NO CAPSULE TEAR, NO VITRECTOMY AND NO SUTURES REQUIRED. NO MEDICATION OUTSIDE THE STANDARD OF CARE WAS PRESCRIBED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 13939767 ↗
• InjuryApr 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 24.0 DIOPTER SYMFONY LENS WAS EXPLANTED FROM THE PATIENT¿S RIGHT EYE DUE TO THE PATIENT EXPERIENCING HALOS AND GHOST IMAGES. THE LENS WAS REPLACED WITH A TORIC IOL ZCT225 23.5 DIOPTER. PATIENT¿S BEST CORRECTED VISUAL ACUITY (BCVA) POST-OP IS 20/30. PER FOLLOW-UP INFORMATION THERE WERE NO COMPLICATIONS OF ANY KIND. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8481350 ↗
• InjuryOct 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT REPORTED THAT A SYMFONY TORIC INTRAOCULAR LENS (IOL) WAS IMPLANTED IN HER RIGHT EYE (OD) ON (B)(6) 2018. REPORTEDLY, AT THE FOLLOW UP VISIT WITH THE SURGEON ON (B)(6) 2018, THE PATIENT COMPLAINED THAT THE LENS WAS NOT WORKING AS SHE COULD NOT READ ANYTHING. THE PATIENT REPORTED BEING AN AVID READER AND NOW SHE IS FRUSTRATED NOT BEING ABLE TO READ SMALL OR LARGE PRINT. REPORTEDLY, THE SYMPTOMS HAVE AFFECTED HER ABILITY TO PERFORM DAILY ACTIVITIES. IT WAS ALSO REPORTED THAT PLUGS WERE IMPLANTED IN THE PATIENT'S EYE DUE TO DRY EYE SYMPTOMS AND TO HELP WITH THE PATIENT'S VISION ISSUES; BUT THEY DID NOT HELP. THE PATIENT CONTINUES TO EXPERIENCE THE SAME VISUAL ISSUES. YAG (YTTRIUM ALUMINUM GARNET) LASER WAS ALSO PERFORMED ON (B)(6) 2018. THE PATIENT STATED THAT HER VISION IS BLURRY UP-CLOSE BUT IS HAPPY WITH HER DISTANT VISION. THE SURGEON WILL IMPLANT AN INTRAOCULAR LENS (NON JOHNSON & JOHNSON LENS) IN THE PATIENT LEFT EYE (OS) AND WILL THEN REASSESS THE PATIENT'' VISION TO DETERMINE IF READING GLASSES WILL BE NECESSARY. TO DATE THERE ARE NO PLANNED INTERVENTION FOR THE RIGHT EYE AND THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON AND JOHN

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 7959653 ↗
• InjuryJan 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017, BECAUSE THE PATIENT REPORTED SEVERE GLARE. PRE AND POST-OPERATIVE BEST CORRECTED VISUAL ACUITY FOR THE PATIENT WAS 20/40. THE REPLACEMENT LENS WAS A ZCT150 21.5 DIOPTER LENS. REPORTEDLY, THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7181310 ↗