MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON LEGION FMS PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065753027
Medical Device Problem Codes	Suction Problem (2170); Failure to Cut (2587)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	01/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported while it was in the quadrant module, it did not cut the cataract or aspirate during cataract surgery (with intraocular lens implant).The patient felt pain.The whole kit was changed and the whole process started again, with no problems in the second kit that was opened and installed.The surgery was completed on the same day.There was a patient contact.The patient condition was resolved.
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).
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A lot number was identified, however the lot does not contain a probe lot number therefore, a device history review, complaint history review, and non-conformance review could not be conducted.The photos were reviewed by the manufacturing site.Photos shows tube with connector.Reported issue cannot be confirmed from photo.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The cause of the reported event cannot be determined with the information obtained; therefore, specific action with regards to this complaint cannot be taken.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: LEGION FMS PACK
• Common Device Name: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 21455767
• Report Number: 1644019-2025-00515
• Device Sequence Number: 18106583
• Product Code: LRO
• UDI-Device Identifier: 00380657530274
• UDI-Public: (01)00380657530274(17)260430(11)240513(10)16TEU6
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: TBD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

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: 04/30/2026
• Device Catalogue Number: 8065753027
• Device Lot Number: 16TEU6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2025
• Supplement Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 02/25/2025
• Supplement Report FDA Received Date: 05/15/2025
• Date Device Manufactured: 05/13/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female