TECNIS IOL ZXT375 (REF ZXT375U145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474606869), received between Jan 13, 2017 and May 6, 2021 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2021Adverse 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 IMPLANTED IN THE PATIENT'S RIGHT EYE (OD). POST-IMPLANT THE PATIENT WAS MYOPIC BY 1.75D, WITH SOME RESIDUAL CYLINDER, AND THE PATIENT WAS VERY UNHAPPY DUE TO HALOS. THE IOL WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A MODEL DIU225 LENS. PATIENT CHART NOTED THAT OD VISION IS WORSE. PATIENT SEES STARBURSTS, ESPECIALLY WHEN DRIVING AT NIGHT AND ONCOMING TRAFFIC LIGHTS ARE VERY BRIGHT. ALSO NOTED WAS POSTERIOR CAPSULE OPACIFICATION (PCO) IN OD, AND A YTTRIUM ALUMINUM GARNET (YAG) PROCEDURE WAS DONE. THERE WERE NO POST-EXCHANGE ADVERSE EVENTS OR INJURIES REPORTED. NO OTHER INFORMATION PROVIDED.

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

  MAUDE report 11787637 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE DOCTOR THAT HE HAD TO EXPLANT A SYMFONY INTRAOCULAR (IOL) LENS FROM THE PATIENT'S RIGHT EYE (OD), DUE TO THE PATIENT EXPERIENCING HALOS WHILE DRIVING AT NIGHT. SYMPTOMS SIGNIFICANTLY AFFECTED DAILY ACTIVITIES. AT EXPLANT, AN INCISION ENLARGEMENT, AND SUTURES WERE REQUIRED, MEDICATION WAS PRESCRIBED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo

  MAUDE report 11325823 ↗
• MalfunctionDec 4, 2018Contamination; Contamination

  IT WAS REPORTED THAT DIRT WAS NOTICED ON THE ZXT375 14.5 DIOPTER INTRAOCULAR LENS (IOL) DURING HANDLING AND PRIOR TO INSERTION. NO PATIENT CONTACT WAS REPORTED. THE ACCOUNT COMMENTED THAT THE LENS WAS DISCARDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8128109 ↗
• InjuryOct 21, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT375 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT REPORTED HIS VISION WAS AMAZING AND HE LOVED IT, BUT GRADUALLY TOWARDS THE END OF (B)(6) 2017 HIS VISION BECAME BLURRY. FOLLOW UP WITH THE DOCTOR SHOWED THAT THE LENS ROTATED 23 DEGREES FROM ITS ORIGINAL POSITION. LASER TREATMENT - LIMBAL RELAXATION INCISION (LRI) AND LENS REPOSITIONING WAS PERFORMED ABOUT A MONTH FROM (B)(6) 2017, BUT WITH NO IMPROVEMENT AS THE LENS WAS STILL OFF BY 11 DEGREES. AT THE PATIENT'S MOST RECENT FOLLOW UP VISIT WITH THE DOCTOR ON (B)(6) 2017, THE POST-OPERATIVE REFRACTION WITHOUT CORRECTION WAS 20/70. HOWEVER, REFRACTION WITH CORRECTION WAS 20/25. THERE IS ALSO NO PLAN TO EXPLANT THE LENS. REPORTEDLY, THE PATIENT HAS HAD A LONG HISTORY OF ASTIGMATISM AND HAD A DETACHED RETINA IN BOTH EYES (OU) A WHILE BACK. THE PATIENT WAS LATER REFERRED TO A DIFFERENT DOCTOR, WHO ALSO REPOSITIONED THE LENS WITH NO IMPROVEMENT AS THE LENS DID NOT ROTATE BACK. THE PATIENT STILL COMPLAINED OF BLURRY VISION, INCLUDING THE INABILITY TO DRIVE AND HAVING DIFFICULTY READING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Visual Impairment

  MAUDE report 6967599 ↗
• InjuryMay 24, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT AFTER IMPLANTATION OF A ZXT375 14.5 DIOPTER INTRAOCULAR LENS (IOL), THE PATIENT HAD ABOUT 2.8D OF ASTIGMATISM. THE PATIENT STILL HAS 1.7D LEFT AND THEIR VISION WAS TERRIBLE. THE AXIS DID NOT FLIP. IN FOLLOW UP WITH THE PHYSICIAN IT WAS NOTED THERE IS NO MISALIGNMENT OF THE IOL, RETAINED VISCOELASTIC, OR DISLOCATION/DECENTRATION OF THE IOL. FROM LOOKING AT THE POST?-OP DATA AS IS; IT APPEARS AN IOL EXCHANGE WOULD NEED TO BE DONE. THROUGH A LATER FOLLOW-UP IT WAS LEARNED THAT THE LENS HAD ROTATED 10 DEGREES POST IMPLANTATION. THE PHYSICIAN REPOSITIONED THE IOL ON (B)(6) 2017 AND THE PROCEDURE WENT WELL. THERE WERE NO MORE COMPLAINTS FROM THE PATIENT AND NO PLANS FOR EXPLANT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6589730 ↗
• InjuryJan 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT375 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO PATIENT NOT BEING HAPPY WITH THEIR VISION. THE LENS WAS REPLACED WITH A ZLB00 14.5 DIOPTER LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available; Pain

  MAUDE report 6248486 ↗