TECNIS IOL ZXT225 (REF ZXT225U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474605725), received between Apr 14, 2017 and Nov 8, 2023 — classified as 9 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT RIGHT EYE DURING SECONDARY SURGERY DUE TO GLARES AND HALOS. TRIED LENS FOR 1.5 YEARS BUT COULD NOT ADJUST. THERE WAS INCISION ENLARGEMENT, SUTURES REQUIRED. THE LENS WAS REPLACED WITH WITH ANOTHER COMPANY IOL. PATIENT WAS FULLY RECOVERED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Halo; Visual Disturbances

  MAUDE report 18097405 ↗
• InjuryApr 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT (OS) EYE DURING THE SECOND PROCEDURE BECAUSE OF VISUAL DISTURBANCES. THE LENS WAS REPLACED WITH A DIFFERENT MODEL LENS. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THE CARTRIDGE USED WITH THE LENS HAS BEEN DISCARDED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11750460 ↗
• InjuryNov 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S OPERATIVE EYE BECAUSE HE EXPERIENCING GLARES AND HALOS AROUND LIGHT SOURCES, ESPECIALLY AT NIGHT, IN THE SHAPE OF SPIDERWEBS. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED. THE REPLACEMENT LENS IS A ZCU150, 17.0 DIOPTER LENS. THE PATIENT WAS REPORTED TO BE DOING WELL. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 10788891 ↗
• InjuryAug 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) EXCHANGE OCCURRED FIVE MONTHS AFTER THE ORIGINAL SURGERY TO GIVE THE PATIENT PLENTY OF TIME TO NEUROADAPT TO THE SYMFONY TORIC IOL. THE DOCTOR INDICATED THAT THE PATIENT HAD TECNIS ZLB00 IN HER OTHER EYE AND CONSTANTLY, ALL THROUGH THE SMOOTH PERIOD, PREFERRED HER VISION IN THAT EYE. VISUAL ACUITY (VA) IN OPERATIVE EYE WAS PRE-OP 20/60, VA POST-OP 20/20. VISUAL SYMPTOMS WERE SYMPTOMS BLURRY AND HALOS. NO ADVERSE EVENTS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 10423134 ↗
• InjuryAug 14, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A FEMALE PATIENT WAS IMPLANTED WITH A 16.5 DIOPTER, MODEL ZXT225 INTRAOCULAR LENS (IOL) IN HER RIGHT EYE (OD). APPROXIMATELY 26 WEEKS POSTOP, THE PATIENT EXPERIENCED HALOS, A LOT OF GLARE AT NIGHT, AND A LACK OF NEAR VISUAL ACUITY. PATIENT'S BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WAS 20/20. ON (B)(6) 2018, ORIGINAL LENS WAS EXCHANGED WITH 17.0 DIOPTER, MODEL ZCT225 IOL AND ISSUES HAVE BEEN RESOLVED WITH THE PATIENT'S BCDVA AT 20/15. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 7783495 ↗
• InjuryMar 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT225, +16.5 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT'S LEFT EYE BECAUSE OF RESIDUAL REFRACTIVE ERROR AND PATIENT COMPLAINING OF BLURRY VISION. REPORTEDLY MODEL ZXT300, +18.0 DIOPTER WAS USED AS REPLACEMENT LENS FOR THE PATIENT. NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED, NO OTHER MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED DOING WELL WHEN DISCHARGED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7340258 ↗
• InjuryOct 16, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO A REFRACTIVE SURPRISE. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, OR SUTURES USED. REPORTEDLY, THE PATIENT IS DOING FINE POST-OPERATIVELY. THE LENS WAS REPLACED WITH A ZXT150 16.0 DIOPTER IOL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS ANOTHER IOL THAT WAS OPENED IN ERROR BY THE TECHNICIAN, BUT WAS NOT USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6950655 ↗
• InjurySep 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 16.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT WAS UNHAPPY WITH THE LENS AND IT WAS LATER EXPLANTED ON (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6854316 ↗
• InjuryApr 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNEXPECTED (POST OP) OUTCOME AFTER IMPLANT OF A ZXT225 16.5 DIOPTER INTRAOCULAR LENS. THROUGH FOLLOW UP IT WAS LEARNED THAT THE IMPLANT AFFECTED THE PATIENT'S DAILY ACTIVITIES AND THEY WERE VERY UNHAPPY WITH THE OUTCOME. IT WAS ALSO LEARNED THAT THE PHYSICIAN WILL PROCEED WITH A YTTRIUM-ALUMINUM-GARNET (YAG) CAPSULOTOMY FIRST; THEN EXPECT THE NEED TO PERFORM A PHOTOREFRACTIVE KERATECTOMY (PRK). THE DOCTOR WILL EVALUATE THE SITUATION AGAIN TO DETERMINE THE POSSIBILITY OF NEEDING TO REMOVE THE IMPLANTED LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6495181 ↗