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

Catalog Number 8065752451

Device Problem Mechanical Problem (1384)

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

Event Date 09/01/2020

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.(b)(4).

Event Description

A customer reported the vitrectomy probe as not cutting during a procedure.The vacuum was reduced and it started to cut intermittently.The issue was resolved after replacing the product with another one.

Manufacturer Narrative

Based on this 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).

Event Description

Additional information was received indicating the customer reported in error and there was no product complaint.

• 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: 10594062
• MDR Text Key: 209233970
• Report Number: 1644019-2020-00521
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

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: 01/31/2022
• Device Catalogue Number: 8065752451
• Device Lot Number: 2364822H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/28/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1