TECNIS IOL ZXT150 (REF ZXT150U170)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05050474605145), received between Feb 23, 2017 and Jun 21, 2021 — classified as 12 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 MODEL INTRAOCULAR LENS(IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO DYSPHOTOPSIA. THE LENS WAS CUT IN HALF AND THE INCISION WAS WIDENED. THERE WAS NO SUTURES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Visual Disturbances

  MAUDE report 12038147 ↗
• InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENTS LEFT EYE, DUE TO SUBJECTIVE VISUAL DISTURBANCE. THE LENS WAS REPLACED WITH A DIFFERENT MODEL IOL, ZCU225, BUT THE SAME DIOPTER POWER. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, NO SUTURES DONE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Visual Disturbances

  MAUDE report 11198605 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ZXT150 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT¿S OCULAR DEXTER (RIGHT EYE) ON (B)(6) 2019. THE ZXT150 17.0 DIOPTER LENS WAS EXPLANTED ON (B)(6) 2020 AND REPLACED WITH A ZCBOO 17.0 DIOPTER LENS DUE TO COMPLAINTS OF INTOLERABLE SEVERE DYSPHOTOPSIA. THERE WERE NO COMPLICATIONS DURING SURGERY AND THE INCISION WAS NOT ENLARGED. THROUGH FOLLOW UP, CUSTOMER ACCOUNT PROVIDED ADDITIONAL INFORMATION CONFIRMING NO SERIOUS PATIENT INJURY, NO UNPLANNED SUTURE(S), NO UNPLANNED VITRECTOMY, AND PATIENT OUTCOME WAS REPORTED AS: DOING WELL. NO ADDITIONAL INFORMATION WAS PROVIDED TO JOHNSON & JOHNSON SURGICAL VISION.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 9739018 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE LEFT EYE AS THE IOL WAS CAUSING DISTORTION AND ABERRATIONS, WITH GLARE/HALOS/BLURRED VISION. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 9325366 ↗
• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S RIGHT (OD) EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNEXPECTED REFRACTIVE SURPRISE. THE REPLACEMENT LENS IS A SAME MODEL BUT A HIGHER DIOPTER (20.0). THE CUSTOMER INDICATED THAT THE LENS WILL NOT BE RETURNED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8913868 ↗
• InjuryOct 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS EXPERIENCING EXTREMELY POOR NEAR AND INTERMEDIATE VISION, IN ADDITION TO HALOS AND GLARE IN BOTH EYES POST IMPLANT OF AN INTRAOCULAR LENS (IOL). A MODEL ZXT150, 17.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE RIGHT EYE. A FUTURE EXPLANT IS PLANNED FOR THIS LENS ON (B)(6) 2018 AND REPORTEDLY THE SYMFONY TORIC LENS WILL BE EXCHANGED FOR TRADITIONAL TORIC LENS. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT THE TECNIS SYMFONY MULTIFOCAL INTRAOCULAR LENS WAS EXPLANTED FROM PATIENT¿S RIGHT EYE IN A SECONDARY PROCEDURE. THERE WAS NO PATIENT INJURY, NO INCISION ENLARGEMENT, NO VITRECTOMY PERFORMED. THE REPLACEMENT LENS WAS REPORTED TO BE A MODEL ZCT150 20.0 DIOPTER IOL. PATIENT WAS DOING FINE WHEN DISCHARGED. THIS REPORT WILL CAPTURE PATIENT¿S RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR PATIENT¿S LEFT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blurred Vision; Halo; No Code Available

  MAUDE report 7968294 ↗
• InjuryJul 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 17.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S OPERATIVE EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WANTED TO CHANGE THE LENS TO A MULTIFOCAL LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. REPORTEDLY, THE PATIENT IS DOING GOOD POST-OPERATIVELY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7672178 ↗
• InjuryJun 8, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 17.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S RIGHT EYE (OD) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A MYOPIC REFRACTIVE ERROR. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 14.0. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7581371 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (MODEL ZXT150 +17.0 DIOPTER) WAS IMPLANTED IN THE RIGHT EYE OF A FEMALE PATIENT ON (B)(6) 2017. THE LENS WAS EXPLANTED ON (B)(6) 2018 AND REPLACED WITH A COMPETITOR NON-TORIC LENS. THE REASON FOR THE EXPLANT WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535501 ↗
• InjuryMar 5, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A TECNIS SYMFONY TORIC MULTIFOCAL INTRAOCULAR LENS (MODEL ZXT150, +17.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING HALOS, GLARE, VISUAL DISTURBANCE, AND UNEXPECTED POSTOP REFRACTION POST IMPLANT. THE REPLACEMENT LENS WAS A MODEL ZCT150, WITH A SMALLER DIOPTER (+16.5). THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 7315496 ↗
• InjuryJun 14, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 17.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE DUE TO SEVERE HALOS AND GLARE. THE ACCOUNT INDICATED THAT THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE LENS WAS EXPLANTED AND THERE IS NOTHING LEFT TO RETURN. THIS REPORT WILL CAPTURE THE LENS EXPLANTED FROM THE LEFT EYE AND A SEPARATE REPORT WILL BE FILED FOR THE LENS EXPLANTED FROM THE PATIENT'S RIGHT EYE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6642360 ↗
• InjuryFeb 23, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED AS PATIENT NEEDED A DIFFERENT POWER LENS DUE TO FLASHES/FLOATERS AND BLURRY VISION. THE LENS WAS REPLACED WITH A SMALLER, 15.5 DIOPTER LENS. THERE WAS NO INCISION ENLARGEMENT, VITRECTOMY, AND NO SUTURES REQUIRED IN THE EXPLANT SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Flashers; Vitreous Floaters

  MAUDE report 6351953 ↗