TECNIS IOL ZXT300 (REF ZXT300U155)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606296), received between May 10, 2017 and Jan 7, 2020 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) OPERATIVE EYE ON (B)(6) 2019. PATIENT COMPLAINED THAT SHE COULD NOT SEE FOOD ON HER PLATE, COULD NOT READ, AND COULD NOT SEE THINGS IN HER KITCHEN CABINETS WITHOUT READERS. SHE CANNOT CLEAN HER COUNTER TOPS, OR READ A NEWSPAPER. RIGHT EYE ASTIGMATISM WAS NOT CORRECTED. SHE HAS HALOS AND BLURRY VISION IN BOTH EYES, FLOATERS IN HER RIGHT EYE. SURGEON SAID BECAUSE THE IOL WAS ALIGNED WITH THE AXIS THERE IS STILL ASTIGMATISM. THE SURGEON WOULD LIKE TO DO LASIK OR A PHOTOREFRACTIVE KERATECTOMY (PRK) AT THE NEXT FOLLOW UP VISIT. SHE DOES NOT WANT TO DRIVE AT NIGHT. WHEN SHE WOULD COVER HER LEFT EYE EVERYTHING WAS BLURRY, WHEN SHE COVERED HER RIGHT EYE EVERYTHING WAS PERFECT. LEFT EYE IS WORKING 20/20, AND THE SURGEON TOLD HER THAT HER RIGHT EYE IS 20/20 AS WELL. SHE WAS INFORMED THAT SHE HAD DIABETIC RETINOPATHY ABOUT TWO WEEKS AFTER HER SURGERY, DURING SECOND POST-OP VISIT. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT REPRESENTS THE RIGHT EYE. A SEPARATE REPORT WILL BE FILED FOR THE LEFT EYE.

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 9560745 ↗
• InjuryApr 12, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT300 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE OF RESIDUAL MYOPIA. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 14.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7427838 ↗
• InjuryOct 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 15.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO VISUAL DISTURBANCES. REPORTEDLY, THERE WAS NO INCISION ENLARGEMENT. THE LENS WAS REPLACED WITH A ZCT225 15.0 DIOPTER IOL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6967640 ↗
• InjuryOct 11, 2017Adverse Event Without Identified Device or Use Problem; Unintended Movement; Adverse Event Without Identified Device or Use Problem; Unintended Movement

  IT WAS REPORTED THAT A ZXT300 15.5 DIOPTER INTRAOCULAR LENS (IOL) IS PLANNED TO BE EXPLANTED DUE TO THE LENS ROTATING. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6943016 ↗
• InjuryMay 10, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (MODEL ZXT300, +15.5 DIOPTERS) WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AS THE ASTIGMATISM WAS OVERCORRECTED. REPORTEDLY, ANOTHER LENS, DIFFERENT MODEL SAME DIOPTER (ZXT150 +15.5) WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6559281 ↗