LuxOR Revalia 00380657530724Recalls & reported problems
Alcon Laboratories, Inc. · Surgical Microscope · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380657530724), received between Apr 17, 2025 and Jul 30, 2026 — 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.
Reports received per month
Most reported problems
Device problems
- Unintended Movement2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2026Unintended Movement
Patient problems: Insufficient Information
MAUDE report 50080384 ↗MalfunctionApr 17, 2025Unintended Movement; Unintended Movement
ADDITIONAL INFORMATION RECEIVED REPORTING THAT THE EVENT OCCURRED BEFORE CATARACT SURGERY.
Patient problems: Insufficient Information
MAUDE report 21855557 ↗
Other MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC devices
- LuxOR 00380657525607Alcon Laboratories, Inc. · MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC35 reports
- OPMI Lumera 700 6634Carl Zeiss Meditec AG · Microscope, Operating & Accessories, Ac-Powered, Ophthalmic2 reports
- LuxOR Revalia 00380657530731Alcon Laboratories, Inc. · MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC2 reports
- ARTEVO 750/850 6649Carl Zeiss Meditec AG · Microscope, Operating & Accessories, Ac-Powered, Ophthalmic1 report
- PROVEO 8 Optics Carrier 000000000010448800Leica Microsystems (Schweiz) AG · MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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