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 Problem Device Embedded In Tissue or Plaque (3165)

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 that a patient had fibers in eye (left eye) from a previous surgery.A secondary procedure was performed and fibers removed without incident.Physician indicated that the patient will use standard post operative drops.

Manufacturer Narrative

Additional information provided in d.10., h.3., h.6., and h.10.The customer did not retain the product lot information for this custom pak, therefore the device history records traceable to the reported pack could not be reviewed.One specimen cup with a medicine cup inside was returned and was visually inspected.Visual inspection confirmed some small debris inside of the medicine cup.Microscopic examination identified several opaque particles up to 8ooum in length.The particle was isolated and analyzed using microscopic fourier transform infrared spectroscopy (micro ft-ir), the opaque particle was identified as (salts).Balanced salt solution (bss) is present and utilized during eye surgery.No fiber was found in the medicine cup.The root cause of the customer's complaint could not be determined conclusively.Custom paks are manufactured in an environmentally controlled area (eca) that is routinely monitored.In addition, the manufacturing area operates in a controlled positive pressure environment and is continuously monitored to prevent entry of foreign material.No action will be pursued at this time for this occurrence.Complaints are continuously monitored to identify product and/or process areas where debris 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.Custom pak manufacturing management has been made aware of this complaint through the consumer affairs review meeting.The manufacturer internal reference number is: 2020-14095.

• 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
• MDR Report Key: 9865997
• MDR Text Key: 184483679
• Report Number: 1644019-2020-00166
• 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: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Date Manufacturer Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACRYSOF SP NATURAL IQ,; BSS BAG 500ML; ACRYSOF SP NATURAL IQ,; BSS BAG 500ML
• Patient Outcome(s): Required Intervention