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

Catalog Number	8065751765
Medical Device Problem Codes	Suction Problem (2170); Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/27/2025
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 the probe could not cut or aspirate during the vitrectomy surgery.The surgery was completed on same day by replacing the product.There was no report of patient impact.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The returned product was visually inspected and confirmed the gray line on the probe manifold were detached due to insufficient solvent.The observed defect most likely resulted in customers complaint.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 most probable root cause of the customer¿s complaint was an assembly error that occurred during manufacturing of the probe manifold for this specific product configuration.During assembly, the tubing that forms part of the probe manifold is required to be wetted with a specified amount of solvent to ensure proper adhesion and mechanical bonding.Evidence collected during the returned product evaluation specifically the detachment of the gray line from the probe manifold indicates that insufficient solvent was applied during the wetting step.When an inadequate amount of solvent is used, the tubing surface is not fully activated, resulting in reduced bonding strength.Over time, or when subjected to normal operational stresses, this insufficient bond can lead to detachment of the manifold components.The failure mode observed on the returned product is consistent with incomplete wetting or improper application of solvent during assembly.Since no deviations, processing anomalies, or material defects were identified during the device record review for the reported lot, the issue is considered isolated to the manual wetting process step for this specific probe manifold product type.This process involves operator dependent tasks, and the variation in solvent application is likely attributable to a single unit assembly error rather than a systemic manufacturing issue.No evidence suggests that other units within the lot or other product lines are affected.This complaint has been reviewed and it is determined that no further actions will be pursued at this time.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all 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.No adverse trends have been observed associated with the reported product and event.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: 23628519
• Report Number: 1644019-2025-04948
• Device Sequence Number: 13357278
• Product Code: LRO
• UDI-Device Identifier: 00380657517657
• UDI-Public: (01)00380657517657(17)270131(11)250225(10)179302
• 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): 05/19/2026

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: 8065751765
• Device Lot Number: 179302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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