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

Catalog Number 8065751777

Device Problem Disconnection (1171)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  Injury  

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.(b)(4).

Event Description

A surgeon reported when he started injecting the silicone oil, while using the extrusion to remove the perfluorocarbon liquid (pfcl), the infusion tube disconnected from the infusion's metal piece while the metal piece stayed attached to the trocar.The surgeon tried twice with a new infusion from a new cassette, and the same happened.He ended the procedure with the heavy liquid remaining in the eye and had the patient scheduled for additional procedure.Additional information was received from the surgeon.The procedure was completed on a different day.He indicated the view wasn¿t great because the pfcl was mixed with silicone oil however he managed to remove it and replace it with silicone oil.He indicated the "previous lasers were scarred" and holding the retinectomy.He indicated he didn¿t perform a direct exchange pfcl/oil but fluid air exchange (fax) then silicone oil.

Manufacturer Narrative

The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

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.The customer reported, that the infusion tube on the cassette disconnected from its metal tip.No sample has been returned for evaluation.Therefore, the condition of the product could not be verified.The root cause of the customer's complaint could not be established, as a sample has not been received.And the condition of the product could not be verified.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any of the device to the reported incident cannot be determined.The root cause for this complaint is not known.Therefore, specific action with regards to this complaint cannot be taken.In-process controls are established to ensure each final assembled cassette is verified, that all required tests have been performed and all acceptance criteria are met prior to release.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
• MDR Report Key: 10927651
• MDR Text Key: 218939568
• Report Number: 1644019-2020-00636
• Device Sequence Number: 1
• Product Code: GAZ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751777
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 02/10/2021; 03/03/2021
• Supplement Dates FDA Received: 03/01/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention