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

Catalog Number ASKU

Device Problem Insufficient Information (3190)

Patient Problems Edema (1820); Foreign Body In Patient (2687)

Event Date 11/08/2016

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.(b)(4).

Event Description

A customer reported that a patient had a fiber removed from the eye; the patient had cystoid macular edema (cme).The surgeon believes the fiber came from the back table cover during the original surgery.No sample returning for this event.Additional information has been requested.

Manufacturer Narrative

The custom pak lot specific to this event is not known; therefore, lot history and device history reviews are not possible.A sample has not been returned for this complaint; therefore, visual inspection could not be performed.Additionally, the customer did not provide any details describing the type of fiber found.This file will be processed for closure and opened at a later date if a sample is returned.The customer's pack was reviewed and various sources were identified as potential contributory factors to fibers for example, gowns, drapes, towels, sponge gauze, eye spears and the back table cover.The root cause of the customer's complaint is not known; a sample was not returned for investigation.An action has been opened to document the investigation and associated corrective action(s) related to custom pak contamination.(b)(4).

• Brand Name: CUSTOM-PAK SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6112565
• MDR Text Key: 60329650
• Report Number: 1644019-2016-01444
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: Yes
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention