TECNIS IOL ZXT150 (REF ZXT150U150)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 05050474605107), received between Mar 24, 2017 and Jan 31, 2022 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2022Adverse 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 DUE TO BLURRINESS, CLOUDINESS, AND GLARE. SYMPTOMS PRESENT SINCE FIST DAY AFTER SURGERY. A NON JOHNSON AND JOHNSON IOL WITH THE SAME DIOPTER SIZE WAS USED AS REPLACEMENT IOL. THERE WAS NO INCISION ENLARGEMENT OR ANY OTHER ADVERSE EVENTS. THE PATIENT WAS HAPPY WITH THE REPLACEMENT LENS. THE SUSPECT PRODUCT HAS BEEN DISPOSED. IT WAS INDICATED THAT A NON JOHNSON AND JOHNSON IOL WAS ALSO IMPLANTED IN THE SECOND EYE OF THE PATIENT AND THE PATIENT WAS MUCH HAPPIER WITH THAT LENS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Blurred Vision; Visual Disturbances

  MAUDE report 13403081 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A MALE PATIENT WAS IMPLANTED BILATERAL INTRAOCULAR LENSES FOR CATARACT. FOR THE LEFT EYE (OS), ZXR00 WAS IMPLANTED. THEN FOR THE RIGHT EYE (OD), ZXT150 WAS IMPLANTED. SOON AFTER BOTH IMPLANTS, THE PATIENT DEVELOPED VISUAL ISSUES. HIS CONCERNS ARE THAT HIS EYES ARE TIRED AND REPEATEDLY ATTEMPT TO CLOSE AFTER 5 PM. ALSO, HIS EYES FEEL DRY, ALSO A LATE AFTERNOON OBSERVATION. BOTH EYES TEAR FREQUENTLY, MORE AT EVENING BUT THROUGHOUT THE DAY. THE SENSATION OF LOOKING THROUGH FRAMES, AS IF USING BINOCULARS. HIS READING VISION IS WORSE THAN IT HAS EVER BEEN. HE HAD ANTICIPATED NOT WEARING GLASSES. THE DARK SPOTS CONTINUE TO SHOW UP OCCASIONALLY, BUT THEY ARE REDUCED IN FREQUENCY. IT WAS LEARNED THROUGH FOLLOW-UP THAT HE HAD YTTRIUM-ALUMINUM-GARNET LASER TREATMENT (YAG) TO REMOVE CELL GROWTH. THE PATIENT MENTIONED THAT HE HAS DRY EYES AND IT MAKES HIS EYES FEEL LIKE THEY HAVE SAND IN THEM AND HIS EYES TEAR. OVER THE COUNTER EYE DROPS WERE PROVIDED BY THE DOCTOR FOR THE DRY EYE SYMPTOMS. THE DROPS HAVE HELPED BUT HAVE NOT ELIMINATED THE SYMPTOMS. HIS DOCTOR HAD NO PLAN TO EXPLANT AND PROVIDED HIM A LETTER INDICATING THAT HIS RESULTS FALL WITHIN THE PARAMETERS OF A SUCCE

  Patient problems: Dry Eye(s); Excessive Tear Production; Visual Impairment

  MAUDE report 9781994 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTRAOCULAR LENS (IOL), MODEL ZXT150 15.0 DIOPTER WAS EXPLANTED DUE TO THE REPORTED HALOS AND GLARE ISSUES. THE REPLACEMENT IOL WAS A MODEL ZCT150 OF THE SAME DIOPTER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 9310848 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM THE PATIENT'S LEFT EYE ON (B)(6) 2018 DUE TO SEVERE GLARE AND HALOS. THERE WAS NO PATIENT INJURY AND NO ADDITIONAL INTERVENTION WAS REQUIRED. THE REPLACEMENT LENS MODEL AND DIOPTER WAS NOT PROVIDED. THE ACCOUNT COMMENTED THAT THE EXPLANTED LENS WILL NOT BE RETURNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Halo; No Code Available

  MAUDE report 8243494 ↗
• InjuryNov 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) MALE PATIENT REPORTED THAT HE HAD BILATERAL INTRAOCULAR LENS IMPLANT IN (B)(6) 2017, AND ISSUES STARTED ALMOST IMMEDIATELY AFTER THE LENSES WERE IMPLANTED. REPORTEDLY, THE ISSUES ARE VARIABLE FOCUS (SOMETIMES HIS VISION IS FINE, OTHER TIMES IT IS BLURRY), NIGHT VISION IS BAD DUE TO HALOS AND HE HAS CONTRAST ISSUES. HE IS ALSO EXPERIENCING SOME TEARING. THE TEARING CAN OCCUR WHEN LOOKING AT ITEMS CLOSE-UP SUCH AS WHEN LOOKING AT HIS DINNER PLATE OR FAR AWAY WHEN READING ROAD SIGNS. THE PATIENT REPORTED THAT ACCORDING TO HIS DOCTOR, THE LENSES ARE WELL POSITIONED AND THERE WERE NO ISSUES DURING THE IMPLANTATION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT PERTAINS TO THE LEFT EYE (OD). A SEPARATE MDR WILL BE FILED FOR THE RIGHT EYE (OS).

  Patient problems: Blurred Vision; Halo; Visual Disturbances

  MAUDE report 8068652 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT150 15.0 DIOPTER INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM A MALE PATIENT'S RIGHT EYE DUE TO PATIENT EXPERIENCING TOO MANY HALOS.

  Patient problems: Halo; No Code Available

  MAUDE report 6430696 ↗