TECNIS IOL ZCU300 (REF ZCU300U165)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474660083), received between Jul 31, 2020 and Mar 16, 2021 — classified as 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryMar 16, 2021Application Program Problem: Dose Calculation Error; Application Program Problem: Dose Calculation Error

  IT WAS REPORTED THAT THE INTRAOCULAR LENS (IOL) WAS EXPLANTED FROM PATIENT'S LEFT EYE DUE TO DIOPTER MISS AND THE PATIENT WAS NOT HAPPY. THE ORIGINAL LENS DIOPTER WAS 16.5 AND THE REPLACEMENT LENS HAVE THE DIOPTER 19.0. NO OTHER MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Discomfort

  MAUDE report 11494748 ↗
• InjuryJul 31, 2020Adverse 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 (OS) DUE TO THE PATIENT BEING DISSATISFIED WITH HER VISION POST-OP. AFTER INITIAL IMPLANT, THE PATIENT NOTICED THAT COLORS APPEAR MORE VIVID, OBJECTS APPEAR BRIGHTER. THE PATIENT IS NOT HAPPY WITH HER OVERALL VISION, SHE FEELS HER NEAR VISION FIELD IS A LOT LARGER THAN IT WAS BEFORE THE SURGERY. IT WAS INDICATED THAT THE PATIENT IS HAVING TROUBLE SEEING IN THE DISTANCE, HAVING TROUBLE SEEING THE TELEVISION OR EVEN ACROSS THE STREET. HOWEVER, THE PATIENT DOES FEEL HER VISION IS IMPROVING. A REPLACEMENT LENS MODEL ZCU375 19.0 DIOPTER WAS USED. THE PATIENT OUTCOME WAS REPORTED TO BE OK. NO FURTHER INFORMATION WAS PROVIDED. POSTOP REFRACTION, +1.75-.25X150. POST OPERATION DISTANCE VISION FOR OS: 20/50 -1, PH: 20/25 -1. AUTO REFRACTION TYPE: NON-DILATED AR; BINOCULAR PD: 57.0 (DIST): +2.00 -0.25 X 068. MANIFEST REFRACTION: +1.75 -0.25 X 060 ADD: +2.25, 20/25 +1 J1+. THE PATIENT HAD BILATERAL LENSES IMPLANTED. THIS REPORT IS FOR PATIENT'S LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE PATIENT'S RIGHT EYE.

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

  MAUDE report 10351446 ↗