LuxOR 00380657525607Recalls & reported problems
Alcon Laboratories, Inc. · Surgical Microscope System · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Alcon LuxOR surgical microscope system is used for eye surgery. The 35 reports mostly describe hardware coming loose or shifting during procedures — loose handles, arms, heads and attachments, plus parts detaching and optics problems. Four reports mention injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00380657525607), received between Mar 10, 2021 and Dec 17, 2025 — classified as 4 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (18 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loose or Intermittent Connection18
- Unintended Movement10
- Optical Problem3
- Detachment of Device or Device Component2
- Appropriate Device Problem Term/Code Not Available1
- Defective Component1
- Unstable1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Insufficient Information13
- Capsular Bag Tear4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Inflammation2
- Discomfort1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 17, 2025Unintended Movement; Unintended Movement
THE NURSE REPORTED THAT OPHTHALMIC MICROSCOPE WITH LOOSE HANDLE, THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 23825982 ↗MalfunctionDec 3, 2025Unintended Movement; Unintended Movement
A CUSTOMER REPORTED THAT THE OPTICS HAD FALLEN OFF AND ONE OF THE GRIPS WAS LOOSE ON THE OPHTHALMIC MICROSCOPE. 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 23706459 ↗MalfunctionDec 3, 2025Unintended Movement; Unintended Movement
A NURSE REPORTED THAT AN OPHTHALMIC MICROSCOPE HANDLE WAS LOOSE. THE INTERNAL SCREWS WERE TIGHTENED, AND THE PROBLEM WAS RESOLVED. THE PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED TO DATE.
Patient problems: Insufficient Information
MAUDE report 23703810 ↗MalfunctionApr 24, 2025Unintended Movement; Unintended Movement
A PHYSICIAN REPORTED THAT DURING SURGERY AN OPHTHALMIC OPERATING MICROSCOPE'S ILLUMIN-I BLOCK DETACHED AND REMAINED IN THE PHYSICIAN'S HANDS WHILE MANIPULATING THE MICROSCOPE TO POSITION IT OVER THE PATIENT'S EYE (UNKNOWN). OTHER PROCEDURE DETAILS HAVE NOT BEEN PROVIDED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21897061 ↗MalfunctionApr 21, 2025Unintended Movement; Unintended Movement
A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE HEAD SLIGHTLY WIGGLE. 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 21871760 ↗MalfunctionMar 21, 2025Unintended Movement; Unintended Movement
A CUSTOMER REPORTED THAT THE ARM OF THE OPHTHALMIC MICROSCOPE IS 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 21662857 ↗MalfunctionMar 12, 2025Unintended Movement; Unintended Movement
A HEALTHCARE PROFESSIONAL REPORTED THAT DURING RETINAL DETACHMENT SURGERY, THE BIOM (BINOCULAR INDIRECT OPHTHALMOSCOPY MICROSCOPE) ATTACHMENT DETACHED FROM THE OPHTHALMIC MICROSCOPE HEAD. THE ATTACHMENT HAD BEEN SECURED WITH ONLY TWO PIECES OF ADHESIVE TAPE, WHICH FAILED TO MAINTAIN STABILITY. THE SURGERY WAS COMPLETED ON THE SAME DAY, AND THE BIOM ATTACHMENT REMAINED IN PLACE THROUGHOUT THE ENTIRE PROCEDURE, WITH NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21582382 ↗MalfunctionMar 6, 2025Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT THE OPHTHALMIC MICROSCOPE HAD THE ISSUE WITH THE HEAD ASSEMBLY LOOSE; THEY TRIED TIGHTENING THE HEAD ASSEMBLY, BUT THE ISSUE WAS STILL THERE. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21534528 ↗MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT, AN OPHTHALMIC MICROSCOPE PART DETACHED FROM THE OPTICAL HEAD. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21195889 ↗MalfunctionJan 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
A CUSTOMER REPORTED THAT BEFORE CATARACT SURGERY, THE LOWER PART OF THE OPTICAL HEAD OF AN OPHTHALMIC MICROSCOPE WAS DETACHED. THE DETAILS OF THE PROCEDURE WAS NOT REPORTED.
Patient problems: Insufficient Information
MAUDE report 21093321 ↗MalfunctionDec 6, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE LIBERO HEAD POSITION WAS NOT AT CENTER AND WHEN THE PHYSICIAN PLACES IT ON CENTER TO RESET IT DRIFTS. PROCEDURE DETAILS WAS NOT REPORTED. THERE WAS IMPACT ON THE PATIENT.
Patient problems: Insufficient Information
MAUDE report 20862435 ↗MalfunctionDec 2, 2024Unintended Movement; Unintended Movement
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC MICROSCOPE OPTICAL HEAD WAS MOVING ON ITS OWN. DETAILS OF PROCEDURE WAS NOT REPORTED. NO PATIENT IMPACT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 20816233 ↗MalfunctionJun 26, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE LIBERO SCREWS REQUIRED THE FIXING. THE DETAILS OF PROCEDURE AND PATIENT IMPACT WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEN REQUESTED AND NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 19615223 ↗MalfunctionMar 29, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE WAS UNSTABLE AND SHAKING. PROCEDURE DETAILS WAS NOT PROVIDED AND THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19003393 ↗MalfunctionMar 1, 2024Unintended Movement; Unintended Movement
A CUSTOMER REPORTED THAT DURING A SURGERY, THE OPHTHALMIC MICROSCOPE WHEELS ARE NOT LOCKING INTO PLACE SO ITS ROLLING AROUND. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 18815330 ↗MalfunctionFeb 26, 2024Unintended Movement; Unintended Movement
A CUSTOMER REPORTED THAT DURING SURGERY AN OPHTHALMIC MICROSCOPE WAS NOT LOCKED AND MOVED. WHEN DOCTOR PUTS FACE UP TO LENSES MICROSCOPE ROCKED AND BOTTOM PIVOT. PROCEDURE DETAILS AND PATIENT IMPACT HAVE NOT BEEN PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: Insufficient Information
MAUDE report 18776706 ↗MalfunctionDec 11, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AFTER A CATARACT SURGERY IN AN OPHTHALMIC MICROSCOPE SCREW WAS FOUND TO BE LOOSE. THERE WAS NO IMPACT TO THE SURGERY AND PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18303296 ↗MalfunctionAug 23, 2023Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AN OPATHALMIC OPERATING MICROSCOPE HEAD WAS LOOSE. PROCEDURE WAS PATIENT IMPACT DETAILS WERE NOT REPORTED. ADDITIONAL INFORMATION REQUESTED NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17601874 ↗MalfunctionJul 27, 2023Defective Component; Defective Component
A HEALTHCARE PROFESSIONAL REPORTED THAT AN OPHTHALMIC MICROSCOPE EXHIBITED WITH LOOSE WHEEL AND CAMERA LOOSE AND OUT OF FOCUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17403406 ↗InjuryApr 21, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
A CUSTOMER REPORTED THAT DURING THE CATARACT PROCEDURE AN OPHTHALMIC MICROSCOPE HAD INCORRECT SETTINGS AFTER THE UPGRADE TO LED LIGHTS. A PATIENT UNDERWENT UNPLANNED ANTERIOR VITRECTOMY PROCEDURE DURING THE IRRIGATION/ASPIRATION (IA) AND POSTERIOR CAPSULAR TEAR. PROCEDURE WAS COMPLETED AND THE SULCUS LENS WAS PLACED.
Patient problems: Capsular Bag Tear
MAUDE report 16783107 ↗MalfunctionAug 18, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AN OPHTHALMIC SURGICAL MICROSCOPE CAMERA WAS MOUNTING LOOSE. PROCEDURE DETAILS AND PATIENT HARM WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15248437 ↗MalfunctionAug 10, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE HEAD IS CLICKING. PROCEDURE DETAILS AND PATIENT IMPACT WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NONE RECEIVED TILL DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15202593 ↗MalfunctionJun 13, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT DURING SET UP OF A SURGERY AN OPHTHALMIC MICROSCOPE HAD LOOSE YOLK SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT OR PROCEDURAL IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14679263 ↗MalfunctionApr 1, 2022Loose or Intermittent Connection; Loose or Intermittent Connection
A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE YOKE SET SCREW WAS LOOSE WHICH UNABLE TO TIGHTEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13974962 ↗MalfunctionDec 2, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
A CUSTOMER REPORTED THAT AN OPHTHALMIC MICROSCOPE'S HEAD DROPPED AND A SYSTEM MESSAGE WAS DISPLAYED DURING A SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12916855 ↗
Other MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC devices
- LuxOR Revalia 00380657530724Alcon Laboratories, Inc. · MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC2 reports
- LuxOR Revalia 00380657530731Alcon Laboratories, Inc. · MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC2 reports
- OPMI Lumera 700 6634Carl Zeiss Meditec AG · Microscope, Operating & Accessories, Ac-Powered, Ophthalmic2 reports
- PROVEO 8 Optics Carrier 000000000010448800Leica Microsystems (Schweiz) AG · MICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC1 report
- ARTEVO 750/850 6649Carl Zeiss Meditec 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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