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

Catalog Number ASKU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 03/28/2019

Event Type  Injury  

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 reported a patient developed toxic anterior segment syndrome after a cataract procedure.Additional information was requested; however, none has been received to date.This is one of seven reports for this surgeon.

Manufacturer Narrative

The lot complaint history was reviewed; this is the seventh complaint for the finish goods lot and seventh for this issue for this lot.The device history record shows the product was released per specifications.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.Custom-paks is an assemblage of single-use medical devices and accessories provided to the customer in a sterile manner.An evaluation is conducted to ensure each requested item meets customer, process, and regulatory requirements.Several sizes are available to accommodate the best fit for the custom-pak.Once the custom-paks are assembled and sealed, they are all sterilized as a complete unit.Sterilization has taken into account the worst case of the pouches to ensure all custom-paks meet all sterilization cycle parameters for acceptability prior to release.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.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.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.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: 8679904
• MDR Text Key: 147369247
• Report Number: 1644019-2019-00095
• 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: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: ASKU
• Device Lot Number: 2219149H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; CENTURION VISION SYSTEM
• Patient Outcome(s): Other