MAUDE Adverse Event Report: Alcon Research, LLC - Houston Viscous Fluid Control Tubing Set (Silicone Oil Inj/Ext); Tubing, noninvasive

Catalog Number	8065750957
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported via health authority that the surgeon used a silicone oil injection/aspiration to inject silicone oil into the vitreous cavity however, the blue connector of the injector could not be securely tightened and repeatedly popped open under injection pressure, preventing the establishment of a sealed pathway for silicone oil infusion during vitrectomy surgery.The surgeon immediately discontinued use of the affected injector and opened a new one.After confirming a secure connection, the procedure was completed successfully.There was no information about patient impact at the time of reporting.
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).

• Brand Name: Viscous Fluid Control Tubing Set (Silicone Oil Inj/Ext)
• Common Device Name: Tubing, noninvasive
• 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 ; +1(800)757-9780
• MDR Report Key: 50469472
• Report Number: 1644019-2026-04489
• Device Sequence Number: 13277651
• Product Code: GAZ
• UDI-Device Identifier: 00380657509577
• UDI-Public: (01)00380657509577(17)271231(11)260116(10)17VYH6
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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: 8065750957
• Device Lot Number: 17VYH6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/03/2026
• Initial Report FDA Received Date: 08/27/2026
• Date Device Manufactured: 01/16/2026
• 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 Age: 57 YR
• Patient Sex: Female