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

Catalog Number 8065751766

Device Problems Positioning Failure (1158); Dull, Blunt (2407)

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

Event Date 12/03/2020

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 physician reported that the trocar was not sharp and was not possible to place in the sclera.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of the trocars are not sharp enough; 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.Because a sample was not received at the manufacturing site and the device history record review indicated that the product was processed and released according to the product¿s acceptance criteria, the exact root cause for this complaint is unknown.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.All trocar blades are 100% inspected.Non-conforming product is removed from the lot.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

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).

• 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: 11072177
• MDR Text Key: 224414431
• Report Number: 1644019-2020-00724
• 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
• Remedial Action: Other
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 8065751766
• Device Lot Number: 2392632H
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/24/2020
• Supplement Dates Manufacturer Received: 02/25/2021; 03/03/2021
• Supplement Dates FDA Received: 03/04/2021; 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1