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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
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 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.
Additional Manufacturer Narrative
Additional information is provided in sections d.9, h.3, h.6 and h.11.The company representative was able to confirm the reported event.The initial report description describes installation of a non-enhanced led upgrade on the microscope by a representative from the customer site (not by a company representative).The dovetail was replaced by the company representative to address the issue.However, the representative mentioned they attributed the initial reported issue to a ¿user error.¿ the system was tested and found to meet product specifications.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 non-conformance based review of the serial number was performed there were no relevant contributing factors identified.A review for complaints reported against this serial number was performed.No similar complaints were reported for the product serial under investigation.The root cause of the reported event is attributed to use error.Manufacturer 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: 21582382
• Report Number: 2028159-2025-00340
• Device Sequence Number: 8833188
• Product Code: HRM
• UDI-Device Identifier: 00380657525607
• UDI-Public: (01)00380657525607(17)250203(11)150428(10)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JM
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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 Expiration Date: 02/03/2025
• 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): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2015
• 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: Male