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

Catalog Number 8065751617

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 10/28/2020

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 pharmacist reported that the "trocar falls off the knife after injection of the oil" during two procedures.Additional information was requested; however, none has been received to date.This is one of three reports for this facility.

Event Description

Additional information provided by the pharmacist who indicated the trocar is separated from the knife during the hand movement between the scleral marking and the placement of the trocar.

Manufacturer Narrative

Based on the information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.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: 10897796
• MDR Text Key: 218699389
• Report Number: 1644019-2020-00629
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065751617
• Device Lot Number: 2394196H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1