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

Catalog Number ASKU

Device Problem Contamination (1120)

Patient Problem Foreign Body In Patient (2687)

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 surgeon found that lint was retained within a patient's eye postoperatively.The current patient outcome is unknown.

Manufacturer Narrative

The customer did not retain the product lot information for this infiniti procedure pack, therefore the device history records traceable to the reported procedure pack could not be reviewed.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 to determine if it was lint.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 product was manufactured in an environmentally controlled area (eca) that is routinely monitored.In addition, the manufacturing area operates in a controlled positive pressure environment and is continuously monitored to prevent entry of foreign material.No action will be pursued at this time for this occurrence.Complaints are continuously monitored to identify product and/or process areas where debris is occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of wearing proper ppe and maintaining clean work areas.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending.The manufacturer internal reference number is: (b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10748084
• MDR Text Key: 214803652
• Report Number: 1644019-2020-00574
• 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: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1