REZOOM IOL NXG1 (REF NXG1BU0215)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05050474520295), received between Dec 12, 2025 and Dec 12, 2025 — 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. How this data works · Data updated Oct 13, 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.

• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING DIFFICULTY SEEING SMALL NUMBERS WITH IMPLANTED INTRAOCULAR LENSES (IOL) IN BOTH EYES. THE PATIENT REPORTED THAT A DOCTOR WHO IS NO LONGER AT THE FACILITY HAD PERIODICALLY LASERED OFF A FILM THAT DEVELOPED ON THE EYES AFTER THE INITIAL IMPLANT SURGERIES, WHICH RESOLVED THE ISSUE IN THE PAST. THE NEW DOCTOR AT THE FACILITY HAS ADVISED THE PATIENT TO USE GLASSES INSTEAD OF PERFORMING THE SAME PROCEDURE. THE PATIENT REPORTED BEING ABLE TO SEE LARGER OBJECTS WELL AND IS GENERALLY SATISFIED WITH OVERALL VISION. THE PATIENT REPORTED A HISTORY OF DIABETES AND DRY EYE BUT HAS NEVER BEEN INFORMED THAT EITHER CONDITION WAS AFFECTING THE VISION. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR THE LEFT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE RIGHT EYE OF THE PATIENT.

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 23790858 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING DIFFICULTY SEEING SMALL NUMBERS WITH IMPLANTED INTRAOCULAR LENSES (IOL) IN BOTH EYES. THE PATIENT REPORTED THAT A DOCTOR WHO IS NO LONGER AT THE FACILITY HAD PERIODICALLY LASERED OFF A FILM THAT DEVELOPED ON THE EYES AFTER THE INITIAL IMPLANT SURGERIES, WHICH RESOLVED THE ISSUE IN THE PAST. THE NEW DOCTOR AT THE FACILITY HAS ADVISED THE PATIENT TO USE GLASSES INSTEAD OF PERFORMING THE SAME PROCEDURE. THE PATIENT REPORTED BEING ABLE TO SEE LARGER OBJECTS WELL AND IS GENERALLY SATISFIED WITH OVERALL VISION. THE PATIENT REPORTED A HISTORY OF DIABETES AND DRY EYE BUT HAS NEVER BEEN INFORMED THAT EITHER CONDITION WAS AFFECTING THE VISION. NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT HAD BILATERAL LENS IMPLANTATION. THIS REPORT IS FOR THE RIGHT EYE. A SEPARATE REPORT WILL BE SUBMITTED FOR THE LEFT EYE OF THE PATIENT.

  Patient problems: Blurred Vision; Posterior Capsule Opacification

  MAUDE report 23789974 ↗