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

Catalog Number	8065753037
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Endophthalmitis (1835); Inflammation (1932)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A healthcare professional reported ventilation filters was not good and did not draw air as soon as a vacuum forms in the bottle during surgery.A cannula was inserted into the top of the bottle to make it run.It was meant that the solution was no longer sterile.There was inflamed eyes and endophthalmitis reported.The surgery details were not reported.
Additional Manufacturer Narrative
No product has been returned the investigation site for evaluation; therefore, the condition of the product could not be verified.Receipt of complaint product or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The investigation conducted a non-conformance review of the reported lot number.No deviations, were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information received, the investigation was unable to conclusively identify the root cause for the reported event as a product was not returned for evaluation.The root cause and its origin are inconclusive and further investigative, or manufacturing actions are not warranted at this time.No manufacturing-related deficiencies were found that potentially could have contributed to the complaint.Potential contributing factor: the customer acknowledged using another company product with concerned company¿s system and should be reminded the directions for use stipulates the use of non-company product can create potential hazards.No further investigative or manufacturing actions are warranted at this time, based on our current tracking, there are no adverse trends for this reported complaint and lot.Complaint data for all company products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.The manufacturer internal reference number is: (b)(4).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.

• 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: 22607404
• Report Number: 1644019-2025-02500
• Device Sequence Number: 10106030
• Product Code: LRO
• UDI-Device Identifier: 00380657530373
• UDI-Public: (01)00380657530373(17)261031(11)241104(10)174HPT
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: TBD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Catalogue Number: 8065753037
• Device Lot Number: 174HPT
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 10/15/2025
• Date Device Manufactured: 11/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALCON MICROSURGICAL INSTRU, CANNULA OPHTHALMIC; BSS STERILE IRRIGATING SOLUTION; LEGION SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown