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

Catalog Number 10564

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

Patient Problem Endophthalmitis (1835)

Event Date 08/13/2020

Event Type  Injury  

Manufacturer Narrative

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.A custom-pak 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 pak and item in the pak meets customer, process, and regulatory requirements.Several sizes are available to accommodate the best fit for the custom-pak.Once the custom-pak is assembled and sealed, they are all sterilized as a complete unit.The sterilization validation 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.A sample was not returned; therefore, the root cause for the customer reported event cannot be determined.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Custom pak and the components inside of the paks are single-use items provided to the customer in a sterile manner.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that a patient experienced endophthalmitis postoperatively.The surgeon has performed "eye draining" everyday.The current patient outcome is unknown.Additional information was received during follow-up.The reporter informed that the patient was still admitted to the hospital.Visual ability has improved and the patient is still receiving antibiotics.

• 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
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514979
• MDR Report Key: 10505193
• MDR Text Key: 206089694
• Report Number: 1644019-2020-00470
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 10564
• Device Lot Number: 2358407H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BILLION BLUE 5 CC; CONSTELLATION SURGICAL PROCEDURE PAK; DUOVISC; MA60AC
• Patient Outcome(s): Hospitalization; Required Intervention