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 Problem No Information (3190)

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.(b)(4).

Event Description

A customer reported that patient returned last month to have fibers removed from the eye.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

Additional information provided.The finished good lot specific to this event is not known; therefore, lot history and device history record review was not possible.The customer reported that they found white fibers in the patient¿s eye.A sample has not been returned for this complaint.When this type of issue occurs, a sample will need to be returned so that a proper investigation can be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.Without a 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.Action will not be taken for this occurrence.Quality assurance will continue to monitor and take action for any future occurrences as is deemed necessary.It is recommended that the customer place the surgical instruments on a mayo tray and if applicable avoid placing them directly on a mayo stand cover or the back table cover.Additionally, the instruments should be wiped before passing back to the surgeon.This will assist in preventing lint contamination on instruments and help to reduce the risk of lint getting into the patient eye.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, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 7952658
• MDR Text Key: 123496943
• Report Number: 1644019-2018-00239
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/10/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1