MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON VISEO SURGICAL DRAPE; DRAPE, PATIENT, OPHTHALMIC

Catalog Number 8065153220

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

Patient Problem Foreign Body In Patient (2687)

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 nurse reported issue with a fiber from the drape going into the patient's eye.In this case, it as not noticed during the initial procedure and the patient returned for an additional procedure to remove a fiber that was observed embedded in the incision during the one week postoperative visit.

Manufacturer Narrative

As the customer did not retain the finished goods lot number, device history record (dhr) and lot history could not be reviewed.The customer reported a fiber in the eye.No sample was returned for this investigation therefore evaluation of the fiber/product could not be performed.It's important to remind the customer an image at a minimum will assist the investigation.The manufacturing area operates in a controlled positive pressure environment and is continuously monitored to prevent entry of foreign material and hair.Additionally, procedures are in place requiring all assembly room personnel to put on a hairnet with an additional hood, as well as a beard cover, when applicable, prior to entering the assembly area.These measures help mitigate the introduction of foreign material and hair into the product.The root cause of the customer's complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.No action will be pursued at this time for this occurrence.Complaints are continuously monitored to identify product and/or process areas where debris or hair is occurring.In addition, routine training and awareness is conducted with all manufacturing associates to reinforce the importance of wearing proper personal protection equipment and maintaining clean work areas.The manufacturer internal reference number is: (b)(4).

• Brand Name: VISEO SURGICAL DRAPE
• Type of Device: DRAPE, PATIENT, OPHTHALMIC
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 9557567
• MDR Text Key: 173914210
• Report Number: 1644019-2020-00021
• Device Sequence Number: 1
• Product Code: HMT
• Combination Product (y/n): N
• PMA/PMN Number: K830822
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065153220
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK; CUSTOM-PAK SURGICAL PROCEDURE PACK
• Patient Outcome(s): Required Intervention