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	06/03/2026
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 needle within the viscoelastic delivery tubing was obstructed resultng in failure to aspirate as intended during surgery.The procedure type was unknown.The surgery was completed on the same day after replacing the product with another one.There was no patient impact.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.The vfc infusion cannula(s), referred to by the customer was not returned.Because the viscous fluid control cannula product was not available for testing, the investigation could not verify the reported conditions or attempt to reproduce the failure.As a result, the assessment relied solely on customer¿provided information, which was insufficient to establish a definitive causal mechanism.The vfc tubing set and 10ml syringe were returned and were in good condition.It's important to remind the customer to return all product associated with the reported event for a full evaluation.Receipt of complaint product or additional information pertinent to this complaint will result in re-evaluation of the complaint investigation.The investigation conducted a non-conformance review of the reported lot number.No deviation were identified that would have contributed to this event 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 confirm the reported event.The vfc infusion cannulas was not returned with the product.A deviation/discrepancy related to the infusion cannula can cause a system message code.However, the symptom code was not reported and therefore we are unable to ascertain which fault error occurred for this event.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, therefore no action will be taken for this occurrence.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: 25652014
• Report Number: 1644019-2026-03441
• Device Sequence Number: 9839058
• Product Code: GAZ
• UDI-Device Identifier: 00380657509577
• UDI-Public: (01)00380657509577(17)271031(11)251130(10)17TXP2
• 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): 06/29/2026

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: 17TXP2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2026
• Initial Report FDA Received Date: 06/29/2026
• Date Device Manufactured: 11/30/2025
• 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