MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LUXOR OPHTHALMIC MICROSCOPES; MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC

Model Number	LX3
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that an ophthalmic microscope head was moved between two surgeries and also had camera problem.Details of procedure was not reported.No patient impact was reported.
Additional Manufacturer Narrative
Additional information is provided in sections b.5.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
Additional information received reporting that the event occurred before cataract surgery.
Additional Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.The event ¿fluid/air exchange issue¿ (a0512) was removed due to "head was moved between 2 surgeries" is an intentional movement of the head rather than the head moving on its own, so "component loose - reportable malfunction" should be removed, and it is not likely that a recurrence would result in serious injury.No further reports will be submitted under mfg report number: 2028159-2025-00484.The manufacturer internal reference number is: (b)(4).

• Brand Name: LUXOR OPHTHALMIC MICROSCOPES
• Common Device Name: MICROSCOPE, OPERATING & ACC., AC-POWERED, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21855557
• Report Number: 2028159-2025-00484
• Device Sequence Number: 11942449
• Product Code: HRM
• UDI-Device Identifier: 00380657530724
• UDI-Public: (01)00380657530724(17)320719(11)220722(10)14X7UA
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LX3
• Device Catalogue Number: 8065753072
• Device Lot Number: 14X7UA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/28/2025
• Supplement Date Received by Manufacturer: 04/12/2025; 05/08/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 04/29/2025; 05/29/2025
• Date Device Manufactured: 07/22/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown