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

Catalog Number	8065752449
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
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 non healthcare professional reported that vitrectomy probe had failed to aspirate or vacuum at an unknown timing.The procedural type was unknown.The surgery was completed after replacing the product with another one.There was no information about patient impact.
Additional Manufacturer Narrative
Additional information provided in h.11.Upon further review of the new information received for this complaint, it was confirmed that the reported suspect product and event was found to be a duplicate of mfg.Report number 1644019-2025-04869.Hence, no further reports will be submitted under mfg.Report number: 1644019-2025-04877.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: 23601184
• Report Number: 1644019-2025-04877
• Device Sequence Number: 18583351
• Product Code: LRO
• UDI-Device Identifier: 00380657524495
• UDI-Public: (01)00380657524495(17)270630(11)250710(10)17HWF3
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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
• Report Date (Section B): 02/04/2026

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: 8065752449
• Device Lot Number: 17HWF3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 07/10/2025
• 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