TECNIS IOL ZXT150 (REF ZXT150U240)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 05050474605282), received between Nov 18, 2016 and Oct 22, 2021 — classified as 13 injuries, 1 malfunction.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A FEMALE PATIENT COMPLAINED THAT SHE IS NOT GETTING THE VISION SHE WAS PROMISED IN HER LEFT EYE. THE PATIENT CAN SEE UP CLOSE AND SURROUNDING BUT FAR AWAY REMAINS BLURRY. THE PATIENT CONSULTED WITH A SECOND DOCTOR AND WAS TOLD THAT SHE WOULD HAVE NEEDED A DIFFERENT INTRAOCULAR LENS (IOL). THE PATIENT HAS BEEN HAVING NAUSEA AND IS NOT ABLE TO DRIVE AT NIGHT. ON (B)(6) 2021, THE IOL WAS EXPLANTED IN A SECONDARY SURGICAL PROCEDURE AND REPORTEDLY A COMPETITOR'S LENS WAS USED AS A REPLACEMENT. THE PATIENT VISITED HER DOCTOR ON (B)(6) 2021 FOR A POST-OPERATIVE EVALUATION AND INDICATED THAT HER VISION IS NOW GOOD. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Nausea

  MAUDE report 12686519 ↗
• InjuryDec 16, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT A TECNIS SYMFONY INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S RIGHT (OD) EYE DUE TO MECHANICAL FAILURE. THERE WAS NO ADDITIONAL SURGICAL INTERVENTION REQUIRED AND PATIENT OUTCOME WAS NOT REPORTED. NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 11024089 ↗
• InjuryJun 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS WAS EXPLANTED FROM A PATIENT'S LEFT EYE IN A SECONDARY PROCEDURE. THE PATIENT OUTCOME WAS REPORTED TO BE OKAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 10177086 ↗
• InjuryMar 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (MODEL ZXT150 24.0 DIOPTER) WAS EXPLANTED FROM PATIENT¿S RIGHT EYE (OD) IN SECONDARY SURGICAL PROCEDURE DUE TO MYOPIC MISS. A REPLACEMENT LENS OF THE SAME MODEL, BUT DIFFERENT DIOPTER (22.0) WAS USED. THE PATIENT IS DOING FINE POST-OPERATION AND NO PATIENT INJURY WAS REPORTED. THERE WERE NO OTHER SURGICAL OR MEDICAL INTERVENTIONS REQUIRED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 9858695 ↗
• InjuryMay 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STUDY PATIENT AT THE 4TH MONTH VISIT, DEVELOPED HALOS/STARBURSTS AND REPORTS THEY HAVE WORSENED COMPARED TO BEFORE SURGERY. IT WAS STATED THAT PATIENT IS VERY BOTHERED OF THE VISUAL ISSUES, DRIVING AT NIGHT. NEVERTHELESS, THE PREOPERATIVE MONOCULAR BEST CORRECTED DISTANCE VISUAL ACUITY (BCDVA) WERE 20/25 FOR RIGHT EYE (OD) AND 20/30 FOR LEFT EYE (OS). AT 4TH MONTH VISIT, VISUAL ACUITY REPORTED TO BE 20/40 RIGHT EYE (OD), 20/32 LEFT EYE (OS). THERE WAS NO INTERVENTION PLANNED. NO OTHER INFORMATION WAS PROVIDED. THIS MDR REPORT PERTAINS TO THE RIGHT EYE (OD). A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE (OS).

  Patient problems: Halo; No Code Available; Visual Disturbances

  MAUDE report 8580819 ↗
• InjuryMar 22, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT LENS MODEL, ZXT150 24.0 DIOPTER IOL (INTRAOCULAR LENS) WAS EXPLANTED DUE TO MECHANICAL COMPLICATIONS OF IOL. THE REPLACEMENT LENS WAS A ZCT150 25.0 DIOPTER LENS. IT WAS ALSO NOTED THAT THERE WAS NO INTERVENTION REQUIRED SUCH AS INCISION ENLARGEMENT, SUTURE AND VITRECTOMY. AFTER THE REPLACEMENT, PATIENT HAD NO COMPLAINTS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8446463 ↗
• InjuryFeb 18, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 24.0 DIOPTER INTRAOCULAR LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 DUE TO A MYOPIC SURPRISE AND THE PATIENT BEING UNHAPPY WITH THE LENS. THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 22.0. 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 8346858 ↗
• InjuryDec 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTREME HALOS AND GHOSTING "CONSTANTLY" SINCE IMPLANT OF THE SYMPHONY INTRAOCULAR LENS (IOL), MODEL ZXT150 (24.0 DIOPTER) IN HER RIGHT EYE (OD). THE LENS WAS EXPLANTED DUE TO PATIENT'S DISSATISFACTION WITH HER VISION, WHICH REPORTEDLY AFFECTED HER QUALITY OF LIFE. THE INCISION WAS ENLARGED AT EXPLANT, REQUIRING SUTURES. VISUAL ACUITY PRE-OPERATIVE: RIGHT EYE (OD): 20/25. VISUAL ACUITY POST-OPERATIVE: RIGHT EYE (OD) SANS CORRECTED: 20/60. OD-GLARE TEST 20/70. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8122806 ↗
• InjuryNov 22, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PLACEMENT OF THE ZXT150 INTRAOCULAR LENS (IOL) IN THE LEFT EYE OF THE PATIENT WAS NOTICED TO BE MISALIGNED DURING THE POST-OP EXAM. THE PATIENT COMPLAINED OF BLURRY VISION AND THE IOL WAS EXPLANTED ON (B)(6) 2018. THE INCISION WAS ENLARGED TO REMOVE THE LENS AND SUTURES WERE USED; NO VITRECTOMY WAS PERFORMED. THE PATIENT WAS REPORTED BEING IN GOOD CONDITION FOLLOWING THE SURGERY. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WAS DISCARDED. ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS LEARNT THAT THE LENS WAS INITIALLY PLANNED TO BE REPOSITIONED. HOWEVER, THE SURGEON THEN DETERMINED THAT THE PATIENT'S EYE WOULD NOT HOLD THE LENS AND DECIDED TO EXPLANT THE LENS INSTEAD. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8098522 ↗
• MalfunctionOct 24, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A HAIR WAS FOUND UNDER A ZXT150 INTRAOCULAR LENS (IOL) DURING PRODUCT HANDLING AND PRIOR TO INSERTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8003424 ↗
• InjuryOct 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD REFRACTIVE SURPRISE AFTER IMPLANTING MODEL ZXT150 24.0 DIOPTER TECNIS SYMFONY TORIC MULTIFOCAL IOL (INTRAOCULAR LENS) IN HER RIGHT EYE (OD). AS A RESULT, IOL WAS EXPLANTED ON (B)(6) 2018. PATIENT OUTCOME IS UNKNOWN. PRODUCT WILL NOT BE RETURNED AS IT WAS DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 7998410 ↗
• InjuryJun 5, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 24.0 DIOPTER LENS WAS IMPLANTED IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2018. IT WAS LATER EXPLANTED ON (B)(6) 2018 BECAUSE THE PATIENT WAS UNABLE TO FOCUS AND SEE AT NIGHT. VISUAL DISTURBANCES NOTED. THE OUTCOME SIGNIFICANTLY INTERFERES WITH ACTIVITIES OF DAILY LIFE. AT EXPLANT THERE WAS NO INCISION ENLARGEMENT, NO VITRECTOMY, AND NO SUTURES USED. THE REPLACEMENT LENS WAS THE SAME MODEL, BUT DIFFERENT DIOPTER OF 23.5. REPORTEDLY, THERE WAS NO PATIENT INJURY AND THE PATIENT HAS RECOVERED. THE EXPLANTED LENS WAS NOTED TO BE DISCARDED BY THE SURGERY CENTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 7568156 ↗
• InjuryMay 24, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 24.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED DUE TO A WRONG DIOPTER SIZE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6590026 ↗
• InjuryNov 18, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MULTIFOCAL TORIC INTRAOCULAR LENS (IOL) WAS PLANNED TO BE EXPLANTED FROM A PATIENT'S EYE. THE LENS WOULD BE REPLACED WITH A MONOFOCAL TORIC BECAUSE OF THE PATIENT EXPERIENCING UNWANTED HALOS AND GLARE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 6115155 ↗