TECNIS IOL ZXT150 (REF ZXT150U250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05050474605305), received between Jun 29, 2017 and Sep 17, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Application Program Problem: Dose Calculation Error” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2021Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem; Application Program Problem: Dose Calculation Error; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 MODEL INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S RIGHT EYE DUE TO BLURRY VISION. THERE WAS NO INJURY AND NO MEDICAL/ SURGICAL INTERVENTIONS WERE REQUIRED. PATIENT WAS DOING OKAY DURING THE POST OP. A REPLACEMENT LENS OF MODEL ZXT300,19.5 DIOPTER WAS USED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Blurred Vision

  MAUDE report 12489493 ↗
• InjuryMar 30, 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 PATIENT'S OPERATIVE EYE REASON FOR EXPLANT NOT PROVIDED. ANOTHER JOHNSON & JOHNSON LENS MODEL ZXR00, LOWER DIOPTER 24.0 WAS IMPLANTED AS A REPLACEMENT. THERE WAS NO COMPLICATIONS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11587297 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED THAT AFTER HIS BILATERAL SURGERIES IN 2018, HIS EYES WOULD CLOSE ON HIM CONTINUOUSLY AND IT IS A STRUGGLE TO KEEP THEM OPEN WHILE DRIVING. THE PATIENT IS LIGHT SENSITIVE AND INDICATED THAT HIS EYES KEEP CLOSING EVEN WHEN HE IS IN A SHADED ENVIRONMENT, NOT EXPOSED TO LIGHTS. THE PATIENT ALMOST QUIT DRIVING BECAUSE OF HIS SYMPTOMS. AFTER HIS SURGERY, THE PATIENT INFORMED HIS DOCTOR OF THE SYMPTOMS, BUT THE DOCTOR DID NOT RESPOND TO HIS COMPLAINT AT THE TIME AND TOLD HIM TO COME BACK AFTER ONE YEAR. THE PATIENT NEEDED TO RETIRE AS HE IS (B)(6) AND STILL FEELS LIKE HE HAS ENERGY TO KEEP GOING, BUT THIS PROBLEM IS HURTING HIM. THE PATIENT HAS ORDERED UV PROTECTION SUNGLASSES WHICH USES THEM. THE PATIENT MADE AN APPOINTMENT TO SEE A SPECIALIST ON (B)(6) 2021, THIS WOULD BE HIS SECOND APPOINTMENT. THE FIRST TIME, THE PATIENT WAS TOLD THAT HE HAS DRY EYE AND WAS PRESCRIBED WITH THERA TEARS (1DROP/4TIMES A DAY) WHICH HE SOMETIMES USES IT EVEN MORE THAT 4 TIMES/DAY. THE PATIENT INDICATED THAT HE DID NOT HAVE ANY DRY EYE ISSUES BEFORE HIS CATARACT SURGERIES. THE PATIENT NOTED THAT THE DROPS DID NOT HELP WITH HIS SYMPTOMS. THE DOCTOR STATED THAT THE PATIENT¿S EYES ARE LAZY W

  Patient problems: Dry Eye(s); Visual Disturbances

  MAUDE report 11305829 ↗
• InjuryJul 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED IN THE PATIENT'S LEFT (OS) OPERATIVE EYE ON (B)(6) 2019. IT WAS LATER EXPLANTED ON (B)(6) 2019, DUE TO AN UNEXPECTED REFRACTIVE OUTCOME. THERE WAS NO COMPLICATIONS REPORTED DURING POSTOP. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8770057 ↗
• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INTRAOCULAR LENS WAS EXPLANTED FROM THE PATIENTS LEFT EYE DUE TO A MYOPIC MISS. THE LENS WAS REPLACED WITH ANOTHER LENS OF THE SAME MODEL BUT LOWER DIOPTER (24.0). THERE WAS NO OTHER INTERVENTION REQUIRED AND THE PATIENT WAS REPORTED TO BE DOING GOOD POST-EXCHANGE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT PREVIOUSLY HAD A RK (RADIAL KERATOTOMY) PROCEDURE WHICH MAY CAUSE THE HEALING PROCESS TO TAKE A LITTLE LONGER. THE PATIENT VISUAL ACUITY AFTER THE INITIAL IMPLANT POST-OP DAY ONE WAS 20/40, AND 20/25, J1 FOLLOWING THE EXCHANGE. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8761240 ↗
• InjuryJun 6, 2019Adverse 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 PATIENTS RIGHT EYE. AFTER INSERTION, THE PATIENT COMPLAINED OF DYSPHOTOPSIA AND THE OUTCOME SIGNIFICANTLY INTERFERED WITH ACTIVITIES OF DAILY LIFE. THE IOL WAS EXCHANGED FOR A NON-JOHNSON AND JOHNSON IOL. THERE WAS NO INCISION ENLARGEMENT PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available; Visual Disturbances

  MAUDE report 8673239 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MODEL ZXT150 INTRAOCULAR LENS (IOL) WAS IMPLANTED INTO THE PATIENT¿S LEFT EYE (OS). POST IMPLANT THE PATIENT DISLIKED THE LENS AND THE LENS WAS SUBSEQUENTLY EXPLANTED. THE EXPLANTED LENS WAS REPLACED WITH A MODEL ZCT LENS. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Code Available

  MAUDE report 7535932 ↗
• InjuryOct 23, 2017Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT A ZXT150 25.0 DIOPTER INTRAOCULAR LENS (IOL) WAS IMPLANTED ON (B)(6) 2017. IT WAS LATER EXPLANTED ON (B)(6) 2017 DUE TO REFRACTIVE ERROR. THERE WAS AN INCISION ENLARGEMENT PERFORMED AND A SUTURE WAS USED. REPORTEDLY, THERE WAS NO PATIENT INJURY. THE LENS WAS REPLACED WITH THE SAME MODEL, BUT DIFFERENT DIOPTER OF 22.5. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6967912 ↗
• InjuryJun 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 25.0 DIOPTER INTRAOCULAR WILL BE EXPLANTED FOR A DIFFERENT POWER SYMFONY LENS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 6679736 ↗