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

Catalog Number	8065753027
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The physician reported that vacuum building suddenly stopped advisory or error message was coming during the cataract surgery.No patient impact was reported.
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
A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Based on our current tracking, there are no adverse trends for this reported complaint.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).
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.Current tracking indicates no adverse trend for this lot for this event.The customer reported a vacuum building suddenly stopped and a system message code occurred.The returned sample was visually inspected and functionally tested.Both irrigation and aspiration luers were intact.Flare shape was observed in the blue socket fitting at the aspiration tubing insertion end.The sample was tested using a calibrated legion console with the current software revision.The sample could be primed and tuned, and the service data could be retrieved from the console.The maximum vacuum, aspiration and irrigation free flow met specification.The root cause of the customer's complaint could not be established since the returned sample met specifications.No contributing factors could be identified that could cause the reported complaint.After the investigation of this complaint, it has been determined that this sample met specifications.Therefore, no action will be taken at this time.Based on our current tracking, there are no adverse trends for this reported complaint.Quality assurance will continue to monitor customer complaints via the complaint review meetings and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
The physician reported that vacuum building suddenly stopped and advisory or error message was coming during the cataract surgery.No patient impact was reported.Additional information was updated that the surgery was completed after replacing the cassette with another one.
Additional Manufacturer Narrative
Additional information provided in b.5.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: 20520277
• Report Number: 1644019-2024-02472
• Device Sequence Number: 8830779
• Product Code: LRO
• UDI-Device Identifier: 00380657530274
• UDI-Public: (01)00380657530274(17)251231(11)240109(10)16EJHH
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/29/2025

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: 12/31/2025
• Device Catalogue Number: 8065753027
• Device Lot Number: 16EJHH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: 12/19/2024; 03/10/2025; 04/04/2025
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 01/09/2025; 04/04/2025; 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2024
• 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 Sex: Unknown