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

Catalog Number	8065751767
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A physician reported that actuation issue of vitrectomy probe occurred during cataract and vitrectomy combined surgery.The condition of aspirating was unknown.The surgery was completed after replacing the product with another one.There was 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.2., h.3., h.6.And h.11.Upon visual inspection of the probe the shut pneumatic driveline was detached from engine port.It appeared there was insufficient solvent on the tubing end which likely resulted in a weak bond contributing to the customer's experience.The detachment of the pneumatic tubing renders the device inoperable (unable to use) and is typically visually detectable by the user during setup.The investigation conducted a non-conformance review of the reported lot number.No deviation was identified that would have contributed to this event and all corresponding production release specifications defined in the device master record were met.The most likely root cause of the customer's complaint is consistent with a manufacturing error than can occur during the wetting/assembly process of the pneumatic tubing with solvent and subsequent insertion to the probe engine.In order to mitigate the occurrence of this type of event, during the manufacturing process, in-process checks during assembly and after final assembly are utilized to help screen out this type of defect from occurring.Potential contributing factor could be related to improper handling of the product if the user chooses to disengage the rear ergonomic shell, which can pull-on the pneumatic tubing that are bonded to the engine ports.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.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trends and take further action, as appropriate.Complaint data for all company products is reviewed monthly to monitor 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 trends 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: 22886267
• Report Number: 1644019-2025-03000
• Device Sequence Number: 20068512
• Product Code: LRO
• UDI-Device Identifier: 00380657517671
• UDI-Public: (01)00380657517671(17)260430(11)240525(10)16U8RN
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/10/2026

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 8065751767
• Device Lot Number: 16U8RN
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2024
• 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: CONSTELLATION VISION SYSTEM.
• Patient Sex: Unknown