LuxOR Revalia 00380657530731Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657530731), received between Jul 10, 2025 and Oct 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Movement” (2 reports).

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.

• MalfunctionOct 8, 2025Unintended Movement; Unintended Movement

  A PHYSICIAN REPORTED THAT, AN OPHTHALMIC MICROSCOPE ASSY HANDLE CLUTCH WAS FOUND UNTIGHT. THERE WAS NO PATIENT CONTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NONE RECEIVED TILL DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23242715 ↗
• MalfunctionJul 10, 2025Defective Component; Unintended Movement; Defective Component; Unintended Movement

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE OPHTHALMIC MICROSCOPE'S CAMERA MOUNT WAS DAMAGED, AND THE MICROSCOPE HEAD HANDLES WERE LOOSE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; NONE HAS BEEN RECEIVED TILL DATE.

  Patient problems: Insufficient Information

  MAUDE report 22466955 ↗