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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that the surgeon performed a right eye silicone oil removal procedure.After completion of the initial surgical steps, preparation was made for silicone oil extraction.The viscoelastic control tubing was opened, and the plunger within the tubing was inserted into the syringe and connected to the machine.During silicone oil removal, it was observed that the plunger could not retract under a vacuum setting of 650 millimeters of mercury (mmhg), preventing normal silicone oil extraction.A new viscoelastic control tubing set was replaced, and the procedure continued without further abnormalities.The patient completed the surgery and returned to the ward in stable condition.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).

• 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: 50671490
• Report Number: 1644019-2026-04661
• Device Sequence Number: 18519921
• Product Code: GAZ
• UDI-Device Identifier: 00380657509577
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 17KN5A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 08/15/2025
• 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