MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751613

Device Problems Particulates (1451); Reflux within Device (1522)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/13/2021

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 customer reported reflux occurred with a whitish deposit in the eye during a vitreoretinal procedure.Additional information was received from the surgeon who stated small white floating particles were noticed coming out of the vitrectome head during cutting while performing a pars plana vitrectomy procedure, for epi-retinal membrane and multiple retinal tears.The vitrectome was replaced and the procedure was completed; however, postoperatively, surgeon observed the particles at the gas-liquid interface in a patients right eye.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.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.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 12468516
• MDR Text Key: 271303486
• Report Number: 1644019-2021-00561
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657516131
• UDI-Public: 00380657516131
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 8065751613
• Device Lot Number: 2441995H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM; CONSTELLATION VISION SYSTEM
• Patient Age: 84 YR