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	11/01/2025
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 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.
Additional Manufacturer Narrative
Additional information provided in sections d.9.H.3.H.6.And h.11.A non-conformance based review of the serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.Service history was reviewed for the system.A service record relevant to the reported complaint was found.Service record (sr) to address the reported event.Per the sr, a manufacturing representative performed an on-site assessment and replicated the reported event.To resolve the issue, the tightened the internal screw, then found the system to meet manufacturing specifications per service test procedure (stp).Per the sr, a manufacturing representative performed an on-site assessment and replicated the reported event.To resolve the issue, the tightened the internal screw, then found the system to meet manufacturing specifications per service test procedure (stp).Given the age of the device and the absence of manufacturing or historical service issues regarding the loose handle, the most likely root cause of the loose handle is normal wear and gradual loosening of internal screws over time.While the exact point at which the screws became loose cannot be determined, the condition is consistent with long-term use rather than a manufacturing-related deficiency.The root cause of the reported event is attributed to gradual loosing of the screws internal of the handle due to wear.However, as to how or when they became loose remains inconclusive.As a correction, an manufacturer representative performed an on-site assessment of the equipment and tightened the untight part.Actions taken per the sr resolved the reported event.This complaint has been reviewed and based on a low occurrence rate, it is determined that no further actions are necessary at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 23703810
• Report Number: 2028159-2025-01786
• Device Sequence Number: 10670658
• Product Code: HRM
• UDI-Device Identifier: 00380657525607
• UDI-Public: (01)00380657525607(17)270131(11)170131(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LX3
• Device Catalogue Number: 8065752560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2017
• 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