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	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A non-health care professional reported via health authority that the viscoelastic control line was used to inject silicone oil tubing could not be connected to the vitrectomy machine interface during vitrectomy surgery.The surgery was completed after replacing with the same model tubing.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 ; 8007579780
• MDR Report Key: 25481366
• Report Number: 1644019-2026-03164
• Device Sequence Number: 10520952
• Product Code: GAZ
• UDI-Device Identifier: 00380657509577
• UDI-Public: (01)00380657509577(17)270831(11)250911(10)17MW1T
• 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): 06/11/2026

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: 17MW1T
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 09/11/2025
• 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