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

Catalog Number	8065751058
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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 physician reported that cassette occurred leakage during the vitrectomy surgery.The surgery was completed on same day by replacing the product.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.Evaluation of the photo of the product confirms the top and base of the auto infusion valve separated indicating a weak weld between the two components which can result in the customer's experience.An auto infusion valve (aiv) process review was performed to include testing, training, and design.The investigation found the aiv tops and bases do not have energy directors.These energy directors primarily help focus and direct the ultrasonic energy to the weld location.Adding energy directors to either the aiv top or base can enable the formation of better and stronger welds.In addition, there were steps of training identified related to in-process testing that likely contributed to this event.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.The root cause of this event was determined to be related to the manufacturing process.The following contributing factors were identified; inadequate in-process testing to detect weak aiv welds, inadequate training for aiv operators to conduct the ¿squeeze/pinch test¿ between the top and base, and design factors.An internal investigation was completed, and action was taken to address each of the contributing factors identified.Actions include procedural enhancements, validation of new molds for the top and base to ensure continued control of critical dimensions and a feasibility study to enhance aiv design to promote a better weld.Complaints are reviewed and monitored for adverse trends on a monthly basis.An adverse trend has been identified related to broken fluid air exchange components.This event is associated with this trend.A non-conformance investigation was conducted, corrective and preventative action implementation is on-going.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 is 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: 22466550
• Report Number: 1644019-2025-02204
• Device Sequence Number: 8093806
• Product Code: LRO
• UDI-Device Identifier: 00380657510580
• UDI-Public: (01)00380657510580(17)260831(11)240913(10)1725YU
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2025

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: 08/31/2026
• Device Catalogue Number: 8065751058
• Device Lot Number: 1725YU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/17/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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 Sex: Unknown