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 Problems Hemorrhage/Bleeding (1888); Hyphema (1911); Foreign Body In Patient (2687)

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Event Description

A physician reported the patient experienced postoperative anterior chamber hemorrhage post trabeculectomy procedure.During postoperative examination the physician noticed fibrous foreign body attached to the nasal side of the anterior chamber of the left eye.Additional procedure was performed to remove the foreign material from the eye.

Manufacturer Narrative

The customer did not retain the product lot information for this custom pak, therefore the device history records traceable to the reported procedure pack could not be reviewed.The customer reported that a piece of foreign was present in their pak.One plastic case with reported foreign material was returned.Several foreign materials were observed in the returned case, however, the customer identified that no.1 of attached picture is the foreign material of the reported complaint.Approximately 1 mm of brownish fiber-like foreign material was observed.Analysis from the particle lab determined that the material inside of the cup was wypall fibers (paper).While the sample confirmed the presence of wypall fibers, the root cause of the customer's complaint could not be conclusively determine as it is unknown when or where the material was first introduced to the pak.An action plan is in place to improve debris containment in the custom pak manufacturing environment to prevent recurrence.Complaints are continuously monitored to identify product and/or process areas where debris and hair is occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of wearing proper personal protective equipment (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).

Manufacturer Narrative

The sample has been received, and in-house evaluation is in progress.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
• 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 ; 8007579780
• MDR Report Key: 13685590
• MDR Text Key: 286876989
• Report Number: 1644019-2022-00179
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male