MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752438
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
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 non-healthcare professional reported that air valve would not open and would not drain during vitrectomy surgery.The procedure was completed on same day after replacement of product.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The returned products was visually inspected, and no obvious defects were found that would contribute to the reported event.The product tested on a calibrated console and an infusion error occurred indicating an infusion flow (auto infusion valve) error.Analysis of the straight-through connector on the infusion cannula assembly identified a blockage in the flow path caused by excess molded material (flash).The system is designed to perform a quality safety to detect for this unwarranted condition and alert the user during priming, prior to surgery.The infusion cannula assembly 'straight through connector' is a supplier-produced molded component.The investigation conducted a non-conformance review of the reported lot number.No deviations that could have contributed to this event were identified and all corresponding production release specifications defined in the device master record were met.The investigation determined that the reported infusion flow error was caused by a blockage within the straight-through connector of the infusion cannula assembly.The root cause of the customer¿s complaint was identified to be insufficient draft on the core pin which led to material adhesion and subsequent degradation of the shutoff surface, resulting in intermittent flash.This excess molded material partially occluded the bore, restricting flow and leading to the customer¿s experience during priming.The straight-through connector is a molded component supplied by an external manufacturer.Action was taken and to address root cause the supplier has replaced damaged core pins, repaired tool damage, and completed gate area tooling repairs.Production of the part will also be ran at nominal parameters for a minimum prescribed period with engineering batch review, along with engineering trials to evaluate increased draft effectiveness.Additionally, supplier will execute verification production runs under heightened inspection to confirm absence of stretched necks, flash, or bore occlusion.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).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE 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: 24127869
• Report Number: 1644019-2026-00454
• Device Sequence Number: 5457284
• Product Code: LRO
• UDI-Device Identifier: 00380657524389
• UDI-Public: (01)00380657524389(17)270731(11)250831(10)17MAL2
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2026

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 Catalogue Number: 8065752438
• Device Lot Number: 17MAL2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2025
• 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