TECNIS IOL ZXT150 (REF ZXT150U190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05050474605183), received between Dec 27, 2016 and Mar 31, 2021 — classified as 17 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 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 A PATIENT¿S LEFT EYE IN A SECONDARY SURGICAL PROCEDURE DUE TO PATIENT EXPERIENCING HYPEROPIA CAUSING ANISOMETROPIA AND ASTHENOPIA. THE PATIENT¿S SYMPTOMS WERE BLURRED VISION WHICH STARTED ON (B)(6) 2020 AND HAD PROGRESSION. A REPLACEMENT LENS MODEL ZXT225 OF 20.5 DIOPTER WAS USED. THE PATIENT OUTCOME AT THE TIME OF DISCHARGE FOR THE LENS EXCHANGE WAS 20/20 AND NO INJURY WAS REPORTED. THE EXPLANTED LENS WAS DISCARDED BY THE ACCOUNT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Impairment

  MAUDE report 11593969 ↗
• InjuryFeb 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TORIC INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE AS IT OVERCORRECTED THE ASTIGMATISM. THE PATIENT ATTEMPTED GLASSES BUT COULD NOT TOLERATE AND WAS HAVING SEVERE SHADOWING OF LETTERS. THE ONSET OF THE VISUAL SYMPTOMS WERE IMMEDIATE AFTER THE SURGERY. THE REPLACEMENT LENS USED IS OF DIFFERENT MODEL SN_(B)(4). THE PATIENT HAS RECOVERED POST-OP. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Visual Impairment

  MAUDE report 11380549 ↗
• InjuryMar 12, 2020Unintended Movement; Unintended Movement

  IT WAS INITIALLY REPORTED THAT A ZXT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) ROTATED. AT ONE DAY POST-OP THE IOL WAS AT 156 DEGREES. THE PATIENT WAS SEEN AGAIN (B)(6) 2019 AND REPORTED BLURRY VISION. THE REPORTED ISSUE WAS NOTED TO SIGNIFICANTLY AFFECT THE PATIENT¿S DAILY ACTIVITIES AS THE PATIENT WAS UNABLE TO SEE CLEARLY, AND AS A LIBRARIAN, SHE NEEDS TO BE ABLE TO SEE. THE PATIENT WAS BROUGHT BACK IN (B)(6) 2019, THE IOL IN THE LEFT EYE WAS ROTATED 34 DEGREES CLOCKWISE AND REMAINS IMPLANTED. THERE WERE NO PATIENT INJURIES. REPORTEDLY, THE PATIENT¿S VISION IS GREAT NOW AND THEY ARE VERY HAPPY. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision

  MAUDE report 9822412 ↗
• InjuryJul 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) SUBLUXATED A FEW DAYS AFTER IT WAS IMPLANTED IN THE PATIENT'S LEFT EYE. THE PATIENT THEN WAS REFERRED TO ANOTHER DOCTOR WHO EXPLANTED THE LENS. IT WAS LEARNT THAT THE SECOND DOCTOR WHO EXPLANTED THE LENS ALSO DID VITRECTOMY BUT THERE WAS NO INCISION ENLARGEMENT AND NO SUTURES PERFORMED. THE LENS WAS REPLACED WITH A THREE PIECE SUTURED LENS. PATIENT WAS WELL POST-EXPLANT. NO FURTHER ACTION IS NEEDED.

  Patient problems: No Code Available; Vitrectomy

  MAUDE report 8820163 ↗
• InjuryJul 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED HAVING BILATERAL IMPLANTS IN (B)(6) 2017 AND IS SEEING HALOS AND STARBURST AROUND THE LIGHTS. THE PATIENT ALSO SEE'S SHADOW LINES WHICH HER DOCTOR INFORMED HER THAT SHE IS SEEING THE RIDGES ON THE LENS. THE PATIENT HAS BEEN SEEING HER DOCTOR EVERY SIX MONTHS AND WAS TOLD THERE IS NOTHING THE DOCTOR CAN DO. AT THIS TIME, THE LENS REMAINS IMPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT REPRESENT THE LENS IMPLANTED IN PATIENTS RIGHT EYE.

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8790794 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THERE WAS A TWO DIOPTER MISS ISSUE WITH THE INTRAOCULAR LENS (IOL) IMPLANTED IN THE PATIENT¿S RIGHT EYE. THE IOL WAS EXPLANTED AND REPLACED WITH A SAME MODEL LENS BUT A HIGHER DIOPTER (21.5). AT EXPLANT THERE WERE NO MEDICAL/SURGICAL INTERVENTION, NO VITRECTOMY, NO SUTURES, AND NO INCISION ENLARGEMENT REQUIRED. PATIENT IS REPORTED TO BE DOING FINE POST-EXCHANGE. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8742983 ↗
• InjuryApr 2, 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 AS THE PATIENT WAS NOT HAPPY WITH HER VISION. THE LENS WAS REPLACED WITH THE SAME MODEL, A DIFFERENT DIOPTER LENS. THE PATIENT REPORTED HER VISION HAD IMPROVED POST OP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8472311 ↗
• InjuryMar 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED AND REPLACED WITH A DIFFERENT MODEL, A ZXT300 17.5 DIOPTER LENS. THERE WAS AN INCISION ENLARGEMENT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8427145 ↗
• InjuryJan 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2019 DUE TO UNKNOWN REASONS. THERE WAS NO INCISION ENLARGEMENT AND NO VITRECTOMY, BUT A SUTURE WAS USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 17.0. 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 8291611 ↗
• InjuryOct 12, 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) WAS IMPLANTED INTO THE PATIENT'S RIGHT EYE ON (B)(6) 2018. REPORTEDLY, THE PATIENT STARTED COMPLAINING OF BLURRY VISION IMMEDIATELY POST-OP AND EVER SINCE. AT 3 MONTHS POST-OP THE SURGEON ASKED FOR A JOHNSON & JOHNSON CONSULTATION TO DISCUSS POSSIBLE REASONS FOR THE UNHAPPY PATIENT, WHOSE VISION CAN NOT GET ANY BETTER THAN 20/60. NO OTHER MEDICAL INTERVENTION WAS PERFORMED BUT THE SURGEON INSERTED A PUNCTAL PLUG DUE TO DRY EYE POST OP. PATIENT HAS NOT BEEN SEEN SINCE AND THEREFORE, IT IS UNKNOWN HOW THE PATIENT IS CURRENTLY DOING. THE SURGEON COMMENTED THAT THERE IS NO PLAN TO EXPLANT THE LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Dry Eye(s); Visual Impairment

  MAUDE report 7963037 ↗
• 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, +19.0 DIOPTER) WAS EXPLANTED IN A SECONDARY PROCEDURE FROM PATIENT'S RIGHT EYE DUE TO THE PATIENT EXPERIENCING VISUAL DISTURBANCE POST IMPLANT. A MODEL ZXT150, WITH A LARGER DIOPTER OF +21.0 WAS IMPLANTED AS THE REPLACEMENT LENS. THE PATIENT HAS RECOVERED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 7315514 ↗
• InjuryJan 3, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE AND REPLACED WITH A NON-AMO LENS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7162659 ↗
• InjurySep 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE LEFT EYE ON (B)(6) 2017. POST-OPERATIVELY, SYMPTOMS WERE SIGNIFICANTLY INTERFERING WITH THE PATIENT'S DAILY ACTIVITIES. THE LENS WAS EXPLANTED ON (B)(6) 2017, DUE TO UNEXPECTED POST-OPERATIVE REFRACTION, VISUAL DISTURBANCE, AND BLURRY VISION. THE LENS WAS REPLACED WITH THE SAME DIOPTER, BUT DIFFERENT MODEL PCB00. REPORTEDLY, THERE WAS AN INCISION ENLARGEMENT. THE EXPLANTED LENS WAS NOTED TO BE DISCARDED. THE PATIENT HAS RECOVERED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 6874633 ↗
• InjuryJul 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SYMFONY TORIC INTRAOCULAR LENS (MODEL ZXT150 +19.0 DIOPTERS) WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2017, FROM THE LEFT EYE OF A FEMALE PATIENT BECAUSE THE PATIENT WAS UNHAPPY WITH THE RESULT. REPORTEDLY, THE PATIENT HAD NO READING VISION AND POOR DISTANCE VISION. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE SURGEON ATTRIBUTES THE EVENT TO PATIENT ISSUES. THE POOR DISTANCE AND NEAR VISION OCCURRED WITH AND WITHOUT RESIDUAL CORRECTION PLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Impairment

  MAUDE report 6746188 ↗
• InjuryApr 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A FEMALE PATIENT'S RIGHT EYE DUE TO STARBURST AND VISUAL DISTURBANCE AT NIGHT. IN ADDITION, THE PATIENT FELT UNSAFE TO DRIVE AT NIGHT. THE LENS WAS REPLACED WITH A ZLB00 18.5D IOL. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY AND NO PATIENT POST-OP INJURY.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 6459187 ↗
• InjuryMar 16, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TORIC INTRAOCULAR LENS (IOL) ROTATED AFTER IMPLANTATION. REPORTEDLY, THE SURGEON WAS PLANNING ON KEEPING THE LENS IN THE PATIENT'S EYE AND REPOSITIONING THE LENS IN A SECONDARY SURGICAL PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNED THAT THE LENS ROTATED BY 141 DEGREES AND IT WAS REPOSITIONED ON (B)(6) 2017, (ONE WEEK AFTER THE IMPLANTATION). NO PATIENT INJURY WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6411976 ↗
• InjuryDec 27, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 19.0 DIOPTER INTRAOCULAR LENS WAS EXPLANTED DUE TO REFRACTIVE ERROR. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 6207532 ↗