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

Catalog Number	8065752435
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that there was no flow from infusion line during vitrectomy surgery.The procedure was completed by replacing the product with new one.There was patient contact but no patient impact.
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 d.9., h.3., h.6., and h.11.The used infusion cannula was returned and visually inspected.The infusion cannula line was occluded with a piece of flash inside the straight through connector.Hard flash was also observed on both sides of the straight through connector.The occlusion in the straight through connector restricted air and fluid from flowing in the infusion cannula line and caused priming failure with a system message code.The system is designed to perform quality safety to detect for this unwarranted condition and alert the user during priming, prior to surgery.The straight through connector is a molded component by our supplier manufacturer.The investigation conducted a non-conformance review of the reported lot number.No relevant deviations were identified, all corresponding production release specifications defined in the device master record were met.The root cause of the customer¿s complaint is related to insufficient draft on the core pin led to material adhesion and subsequent degradation of the shutoff surface, resulting in intermittent flash and/or occlusion of the molded bore.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: 24232042
• Report Number: 1644019-2026-00610
• Device Sequence Number: 10269557
• Product Code: LRO
• UDI-Device Identifier: 00380657524358
• UDI-Public: (01)00380657524358(17)270930(11)251028(10)17R89M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/20/2026

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: 8065752435
• Device Lot Number: 17R89M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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 Age: 67 YR
• Patient Sex: Female