MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION Surgical Procedure Pack; GENERAL SURGERY TRAY (KIT)

Catalog Number	8065752448
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/07/2026
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).H.10 reflects all related report numbers associated with this product event that have been submitted at this time.
Event or Problem Description
A non-healthcare professional reported that probe did not cut at during the vitrectomy surgery.The surgery was completed by opening new pack.There was patient contact during the vitreous removal phase but no information about patient impact.

• 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: 25388681
• Report Number: 1644019-2026-02967
• Device Sequence Number: 5191438
• Product Code: LRO
• UDI-Device Identifier: 00380657524488
• UDI-Public: (01)00380657524488(17)270331(11)250417(10)17C7F2
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/29/2026

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: 8065752448
• Device Lot Number: 17C7F2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/24/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2026
• Supplement Date Received by Manufacturer: 06/12/2026; 09/03/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 07/07/2026; 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION SURGICAL PROCEDURE PACK; CONSTELLATION SURGICAL PROCEDURE PACK; CONSTELLATION SURGICAL PROCEDURE PACK; CONSTELLATION SURGICAL PROCEDURE PACK
• Patient Sex: Unknown