TECNIS IOL ZXT300 (REF ZXT300U260)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474606500), received between Jul 24, 2019 and Sep 6, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD THE IOL IMPLANTED IN PATIENT¿S BOTH OPERATIVE EYES. REPORTEDLY RIGHT EYE HAD IMPLANT ON (B)(6) 2018 AND THE LEFT EYE HAD IMPLANT ON (B)(6) 2018. 1 MONTH LATER PATIENT WAS COMPLAINING HALOS, STARBURST AND NIGHT DRIVING. DOCTOR HAS DISCUSSED POSSIBLE EYE DROPS IN THE FUTURE PRIOR TO NIGHT DRIVING TO HELP CONSTRICT PUPILS AND HAS BEEN MONITORING THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED, AND IT WAS LEARNT THAT AT 6 MONTHS VISIT PATIENT WAS EXTREMELY BOTHERED STARBURSTS AND GLARE WHICH IS AFFECTING NIGHT DRIVING AND DAILY ACTIVITIES. THE LENS IN BOTH THE EYES REMAINS IMPLANTED WITH NO INTERVENTION PLANNED. THIS REPORT WILL CAPTURE INFORMATION FOR PATIENT¿S LEFT EYE. ANOTHER REPORT IS BEING SUBMITTED FOR PATIENT¿S RIGHT EYE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Dry Eye(s); Halo; No Code Available; Visual Disturbances

  MAUDE report 8968324 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ZXT300 26.0 DIOPTER LENS WAS THE SECOND JNJ IOL IMPLANTED IN THE PATIENT¿S LEFT EYE. THE PATIENT IS EXPERIENCING BLURRY VISION SINCE SHE CANNOT READ CLOSE-UP. SHE FEELS THIS IS AFFECTING HER DAILY LIFE. CONSEQUENTLY, SHE WILL HAVE TO WEAR CONTACT LENSES. AT THE TIME OF THIS CALL NO ADDITIONAL PROCEDURES HAD BEEN PLANNED OR SCHEDULED. PER THE PATIENT, THE DOCTOR SUGGESTED SURGERY, BUT THE PATIENT IS NOT CONSIDERING ANY MORE SURGERIES. VIA FOLLOW-UP IT WAS LEARNED THAT THE DOCTOR PRESCRIBED CONTACT LENSES. HOWEVER, SHE HAS MORE ASTIGMATISM THAN THE DOCTOR EXPECTED AND THE CONTACT LENSES DID NOT HELP HER VISION. REPORTEDLY, THE DOCTOR SAID THEY WILL HAVE TO TRY TORIC HARD CONTACT LENSES TO FIX HER ASTIGMATISM. ADDITIONALLY, THE PATIENT REPORTED THAT HER DOCTOR ONLY TESTED HER PRE-SURGERY WITH CONTACT LENSES ON. SHE PROVIDED THE FOLLOWING PRE AND POST VISION OUTCOME. PRE-SURGERY VISION WITH CONTACTS: LEFT EYE: 20/50 +2, RIGHT EYE: 20/30 -2. POST-SURGERY LEFT EYE: L 21/50 +2 (WITHOUT CONTACTS) NOTE:PATIENT LIKELY MEANT 20/50, BUT HER VISION WAS BLURRY SO THE IOL WAS EXPLANTED. SECOND LENS INFORMATION FOR THE LEFT EYE-THIS REPORT. SECOND LENS FOR THE LEFT EYE ''SOO

  Patient problems: Blurred Vision; No Code Available

  MAUDE report 8820242 ↗