TECNIS IOL ZXT300 (REF ZXT300U145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05050474606272), received between Sep 5, 2017 and Dec 21, 2020 — classified as 5 injuries.

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. 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.

• InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WHICH WAS IMPLANTED IN A PATIENT¿S LEFT EYE ABOUT 3 MONTHS AGO WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING HALO AND GLARE. IT WAS LEARNED THE PATIENT WAS UNABLE TO DRIVE AT NIGHT DUE TO STARBURST/GLARE. AT EXPLANT, THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES, AND NO POST-EXPLANT INJURIES. A MONOFOCAL LENS WAS USED AS THE REPLACEMENT IOL. THE EXPLANTED LENS WAS CUT IN TWO TO REMOVE, AND WAS NOT SAVED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 11051930 ↗
• InjuryJan 6, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A MODEL ZXT300 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE BECAUSE OF BLURRED VISION AND MECHANICAL COMPLICATION OF LENS. PRE-OP VISUAL ACUITY (VA) 20/80. NO SURGICAL INTERVENTION SUCH AS VITRECTOMY, INCISION ENLARGEMENT OR SUTURES WERE REQUIRED. THE REPLACEMENT LENS USED IS A MODEL ZXT300 WITH 12.0 DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 9556051 ↗
• InjuryMay 16, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT300, +14.50 DIOPTER) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE BECAUSE OF THE PATIENT EXPERIENCING RESIDUAL ASTIGMATISM AND LENS DISLOCATION. THE LENS WAS REPLACED WITH MODEL ZA9003, +15.0 DIOPTER. AT EXPLANT THE INCISION WAS ENLARGED AND SUTURES WERE USED. THE PATIENT WAS REPORTED TO BE DOING WELL AT DISCHARGE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7517386 ↗
• InjuryMar 23, 2018Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A ZXT300 14.5 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2017. POST-OPERATIVELY, THE PATIENT HAD RESIDUAL ASTIGMATISM AND THE LENS ROTATED OUT OF IT'S INITIAL AXIS POINT. THEREFORE, A LENS REPOSITIONING PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO PLACE THE LENS BACK AT IT'S ORIGINAL AXIS POINT. ALSO, THE DOCTOR USED AN OCULAR RESPONSE ANALYZER (ORA), WHICH TOLD HIM NO MORE ROTATION WAS RECOMMENDED. REPORTEDLY, THE PATIENT STILL HAD A RESIDUAL CYLINDER OF 2.75 AFTER THE LENS REPOSITIONING PROCEDURE AND THE FINAL REFRACTION WAS 0.50 X -2.50 X 65 DEGREES. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THERE ARE NO PLANS OF ANYMORE SURGICAL INTERVENTION AT THIS MOMENT IN TIME. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT IS DOING FINE POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7364796 ↗
• InjurySep 5, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT300 14.5 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE LEFT EYE (OS) ON (B)(6) 2017 BASED ON OCULAR RESPONSE ANALYZER (ORA) CALCULATIONS. HOWEVER, THE PATIENT OUTCOME WAS 1.5 DIOPTER MYOPIA POST-OPERATIVELY. THE DOCTOR EXPLANTED THE LENS ON (B)(6) 2017. THE LENS WAS REPLACED WITH THE SAME MODEL NUMBER, BUT LOWER DIOPTER OF 13.0, WHICH WAS THE DOCTOR''S ORIGINAL CALCULATIONS WITHOUT ORA. THE PATIENT IS NOW HAPPY AND SEES BETTER WITH A VISUAL ACUITY OF 20/25. IT WAS ALSO NOTED THE PATIENT IS 20/25 WITH A ZXT300 IN THE RIGHT EYE (OD). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6844173 ↗