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

Catalog Number 8065752201

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2019

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 physician reported that the tip of the irrigation/aspiration sleeve was found to be torn during a procedure.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed, this is the third complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The customer returned two infusion sleeves.The first infusion sleeve with was visually inspected and it was found that the tip of the sleeve was completely torn off.No damage was identified with the second infusion sleeve.The torn off tip shaft was not returned.Microscopic examination found the damage is consistent with damage that occurs when a phaco tip snags the sleeve during mounting of the sleeve onto the phaco tip.The root cause of the customer¿s complaint is related to user error.The entire tip and shaft of the infusion sleeve was torn off which is consistent with damaged observed when the sleeve is mounted improperly during setup of the handpiece.No action will be taken for this occurrence, as the root cause is related to user error of the product.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 9175536
• MDR Text Key: 182968622
• Report Number: 1644019-2019-00152
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 8065752201
• Device Lot Number: 2251134H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM