TECNIS IOL ZXT150 (REF ZXT150U260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 05050474605329), received between Dec 23, 2016 and Mar 5, 2020 — classified as 7 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. 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.

• InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TECNIS SYMFONY TORIC (MODEL ZXT150 +26.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S LEFT EYE IN SECONDARY SURGICAL PROCEDURE BECAUSE OF PATIENT EXPERIENCING DYSPHOTOPSIA. PATIENT IS OUTCOME IS REPORTED AS OKAY. REPORTEDLY PATIENT HAD A MONOFOCAL INTRAOCULAR LENS AS REPLACEMENT LENS. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9791224 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT WITH BILATERAL IMPLANT OF INTRAOCULAR LENSES (IOLS) THAT HE WAS EXPERIENCING BLURRED VISION, HALOS AND GLARE WHICH BEGAN SOON AFTER THE LENSES WERE IMPLANTED. THE SYMPTOMS AFFECT HIS ABILITY TO DRIVE AT NIGHT. ADDITIONAL INFORMATION RECEIVED REVEALED THAT PATIENT HAS USED PRESCRIPTION AND OVER THE COUNTER (OTC) EYE DROPS TO TREAT DRY EYE ISSUES WHICH ALSO BEGAN AFTER THE IOLS WERE IMPLANTED. THE EYE DROPS DID NOT HELP ALLEVIATE THE DRY EYE AND HE HAS DISCONTINUED THERE USE. THE PATIENT REPORT HIS VISION IS GOOD BUT THE GLARE IS SEVERE. NO ADDITIONAL INFORMATION WAS RECEIVED. THIS REPORT IS FOR THE RIGHT EYE (OD); A SEPARATE REPORT IS BEING SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 8502349 ↗
• InjuryNov 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ZXT150 INTRAOCULAR LENS (IOL) +26.0 DIOPTER, WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018. REPORTEDLY, ONE DAY POST-OP THE PATIENT PRESENTED A MYOPIC OUTCOME/POOR DISTANCE VISUAL ACUITY. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND A ZXT150 +24.5 DIOPTER LENS WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY WAS PERFORMED AND NO SUTURES WERE USED. THE PATIENT WAS REPORTED BEING HAPPY AFTER THE LENS EXCHANGE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8093935 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 26.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A RESIDUAL REFRACTIVE ERROR. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS A ZXR00 25.0 DIOPTER LENS. THERE WAS NO PATIENT INJURY AND THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7958956 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 26.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE. IT WAS LATER EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7695858 ↗
• InjuryMay 7, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT150, +26.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM THE PATIENT¿S RIGHT EYE BECAUSE AN INCORRECT LENS POWER WAS SELECTED INITIALLY. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT PATIENT WAS EXPERIENCING BLURRY VISION AND THE WRONG POWER WAS IMPLANTED. THE LENS WAS REPLACED WITH ANOTHER ZXT150 OF A LOWER DIOPTER (24.0). THE PATIENT WAS REPORTED TO BE DOING GREAT WHEN DISCHARGED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7493289 ↗
• InjuryDec 23, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 26.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO THE PATIENT'S MACULAR DRUSEN WHICH WAS WORSE THAN ORIGINALLY THOUGHT, THUS THE PATIENT WAS NOT SATISFIED WITH HER VISION. THE LENS WAS REPLACED WITH A ZCT150 LENS. THE PHYSICIAN NOTED THAT THE LENS WAS NOT AT FAULT. THE MACULAR DRUSEN WAS NOT VERY APPARENT BEFORE REMOVING THE CATARACT BECAUSE THE CATARACT WAS BLOCKING THE BETTER VIEW OF THE RETINA. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6203408 ↗