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	12/25/2025
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 nurse reported that the tubing leaked occurred during vitrectomy surgery.The surgery was completed on the same day after replacing the product with another one.There was no impact to the patient.
Additional Manufacturer Narrative
Additional information provided in d.9., h.3., h.6.And h.11.The unused viscous fluid control (vfc) tubing set, small parts tray (smpt) and 10millilitre (ml) syringe were returned and visually inspected.In return condition, the gray tip plunger was inside the smpt.The vfc tubing set, 10ml syringe, and smpt were found to be in good condition.The 25 guage (ga), 23ga and 20ga vfc cannula needle tips could fit into 10ml syringe.The vfc tubing set and gray tip plunger could fit into lab 10ml syringe.The vfc tubing set was tested using a calibrated console.The light emitting diode rings on the console turned green as the gray connector was engaged to the console indicating the proper communication between the connector and the console.The plunger performed smoothly; radio frequency identification (rfid) connection to the console and the syringe to the adaptor/tubing securely engaged, not detached.The pressure was stable in both injection and extraction settings.No air leak occurred from the sample during testing.The investigation conducted a non-conformance review of the reported batch number.No deviations that could have contributed to this event were identified and all corresponding production release specifications defined in the device master record were met.Based on the evaluation of the information and materials received, the investigation was unable to identify the root cause or origin of the reported event.The product functioned per specifications.Additionally, no manufacturing-related deficiencies were found that potentially could have contributed to the complaint.No further investigative or manufacturing actions are warranted at this time due to the product meeting specifications.Receipt of additional relevant information or supporting materials will prompt a re-evaluation of the complaint investigation.Complaint data for all products is reviewed monthly to monitor for adverse trends.During the last review, no adverse trends were observed for the reported product and event combination.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No further action warranted at this time.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: 24141768
• Report Number: 1644019-2026-00476
• Device Sequence Number: 21207797
• Product Code: GAZ
• UDI-Device Identifier: 00380657509577
• UDI-Public: (01)00380657509577(17)270731(11)250815(10)17KN5C
• 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,Followup
• Report Date (Section B): 05/21/2026

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: 17KN5C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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