TECNIS IOL ZXT225 (REF ZXT225U255)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474605909), received between Nov 4, 2016 and Nov 7, 2018 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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.

• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT225 25.5 DIOPTER INTRAOCULAR LENS (IOL) IS SCHEDULED TO BE EXPLANTED ON (B)(6) 2018 DUE TO PATIENT'S SYMPTOMS OF SEVERE HALOS, GLARE AND SEVERE VISUAL DISTURBANCES IN BOTH EYES (OU). THE SYMPTOMS ARE CAUSING SEVERE MIGRAINES AND THE PATIENT AND IS UNABLE TO ACCOMMODATE. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE PATIENT¿S LEFT EYE (OS). A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE (OD).

  Patient problems: Halo; Headache; No Code Available; Visual Disturbances

  MAUDE report 8047240 ↗
• 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 RIGHT EYE (OD). A SEPARATE REPORT HAS BEEN SUBMITTED TO LEFT EYE (OS).

  Patient problems: Halo; No Code Available

  MAUDE report 7656133 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT A PATIENT EXPERIENCED INFLAMMATION, GLARES AND LIGHT SENSITIVITY ON BOTH EYES ON A POST ¿OP EXAM AFTER IMPLANTATION OF A TECNIS SYMFONY MULTIFOCAL MODEL ZXT225 INTRAOCULAR LENS (IOL) IN BOTH EYES. BOTH INITIAL PROCEDURES WERE DONE IN (B)(6) 2017. THE SURGERY CENTER INDICATED THE SURGERIES WENT WELL AND THE PATIENT OVERALL HAS BEEN SATISFIED WITH VISION. THE UNCORRECTED DISTANCE VISION HAS RANGED BETWEEN 20/30 TO 20/40 IN EACH EYE AND THE UNCORRECTED NEAR VISION HAS RANGED BETWEEN J2 TO J3 FOR EACH EYE. THE REFRACTION HAS BEEN -0.25 SPHERE FOR THE RIGHT EYE AND LEFT EYE. THE PATIENT COMPLAINT¿S THAT IS THAT THE NIGHT TIME GLARE REALLY BOTHERS HER AND THE PATIENT DOES NOT LIKE TO GO OUT AT NIGHT BECAUSE OF THAT. THE PATIENT ALSO FINDS CERTAIN LIGHTING TO BE QUITE BOTHERSOME. THE PATIENT WAS TREATED WITH ALPHAGAN DROPS AND PILOCARPINE DROPS. THE SURGERY CENTER RECOMMENDED TRYING ANTI-REFLECTIVE COATING AT NIGHT AND DURING THE DAY UV PROTECTIVE SUNGLASSES. THE PATIENT FINDS NOTHING HAS HELPED WITH THE GLARE. THE PATIENT HAS HAD LONGSTANDING POST-OP INFLAMMATION THAT HAS RECENTLY SETTLED DOWN USING DUREZOL DROPS. THE PATIENT¿S SYMPTOMS ARE INTERFERING WITH DAI

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 6995343 ↗
• InjuryDec 13, 2016Adverse 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 EXPLANTED FROM A FEMALE PATIENT'S LEFT EYE, AS THE PATIENT'S VISION WAS NOT AS CLEAR AS THE PHYSICIAN HAD INTENDED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6172416 ↗
• MalfunctionNov 4, 2016Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BLACK PARTICLES WERE NOTICED ON AN INTRAOCULAR LENS (IOL). NO PATIENT CONTACT REPORTED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A BACKUP LENS. THE PATIENT WAS REPORTED BEING FINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 6078060 ↗