MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT); TUBING, NONINVASIVE

Catalog Number 8065750957

Device Problems Disconnection (1171); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/04/2023

Event Type  malfunction  

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 Description

A nurse reported that the connection between the control tube and the silicone oil injector ruptured and separated during the silicone oil injection of the vitrectomy surgery.The surgery was completed after replacing the product.There was no patient harm.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.It is important to remind the customer directions for use (dfu) for the viscous fluid control (vfc) device stipulates in the warnings section the system used in conjunction with the vfc pak constitutes a complete surgical system.Use of disposables other than those of the customer used bausch + lomb device may affect system performance and create potential hazards.In addition, it also reminds the customer mismatch of consumable components and use of settings not specially adjusted for a particular combination of consumable components may create a patient hazard.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.There was also no specific images or evidence provided to ascertain causality of this event.A review of the report indicates the root cause of the event is likely related to the customer not following the device's directions for use.The report confirms a mismatch of devices during this event which is not recommended when using the vfc device.The root cause for this complaint is related to the customer not following the device instructions/warnings, therefore, specific action with regards to this complaint will not be taken.Current tracking indicates no adverse trend for this lot for this event.In-process controls are established to ensure each device meet acceptance criteria prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISCOUS FLUID CONTROL TUBING SET (SILICONE OIL INJ/EXT)
• Type of Device: 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: 16834120
• MDR Text Key: 314215491
• Report Number: 1644019-2023-00493
• Device Sequence Number: 1
• Product Code: GAZ
• UDI-Device Identifier: 00380657509577
• UDI-Public: 00380657509577
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750957
• Device Lot Number: 1502RU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1