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 left eye silicone oil removal surgery.After completing the patient's preliminary surgical preparations, the surgeon prepared to remove the silicone oil.The viscoelastic control tubing was opened, and the plunger within the tubing was fully advanced into the syringe before being connected to the machine for silicone oil removal.During the procedure, it was observed that under a vacuum setting of 650 millimeters of mercury (mmhg), the plunger failed to retract normally, preventing the silicone oil removal procedure from being carried out as intended.The surgery was completed on same day after replacing the product with another one, and there were no other abnormalities.The patient returned smoothly to the ward after completing the surgery.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: 50672150
• Report Number: 1644019-2026-04665
• Device Sequence Number: 15992176
• 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: 17DL44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/16/2026
• Initial Report FDA Received Date: 09/08/2026
• Date Device Manufactured: 05/01/2025
• 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