MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752201

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

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

Event Description

A customer reported that aspiration failure was brought by the clogged balanced tip during a procedure.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

One opened phacoemulsification tip in a tray was received for the report of the tip was clogged during surgery.The phacoemulsification tip was visually inspected and deemed nonconforming.There was clear foreign material present in the aspiration bypass (ab) hole inside diameter causing occlusion.There was also wear on the flange and threads.The phacoemulsification tip with the foreign material in the ab hole was sent to particle lab for analysis.The foreign material inside the ab hole was analyzed using fourier-transformer infrared spectroscopy (ftir) analysis and the elemental composition of the clear occluding material closest match was bovine albumin (protein).The exact identity is unknown.A review of the device history records traceable to the reported lot number, indicates that the product was processed and released according to the product¿s acceptance criteria.The complaint evaluation confirms the phacoemulsification tip ab hole was occluded with foreign material.The foreign material was analyzed using ftir analysis and the elemental composition of the clear occluding material to best match bovine albumin (protein); however the exact identity is unknown.Bovine albumin (protein) is not used in the manufacturing or packaging process of phacoemulsification tips.How and when the foreign material became present in the ab hole cannot be determined from this evaluation and a root cause for or the customer complaint issue cannot be determined.No specific action with regard to this complaint was taken because the source of the foreign material is not related to any manufacturing process.All phacoemulsification tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No the manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 11088911
• MDR Text Key: 224840233
• Report Number: 1644019-2020-00732
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 8065752201
• Device Lot Number: 2381559H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM, ITC.; CENTURION VISION SYSTEM.