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

Catalog Number ASKU

Device Problem Break (1069)

Patient Problems Fluid Discharge (2686); Device Embedded In Tissue or Plaque (3165)

Event Date 11/05/2019

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

Event Description

A company representative reported a surgeon experienced a broken phaco needle during a procedure.Upon completion of the procedure, it appeared as "nothing was wrong".The patient returned for the one day postoperative visit and was experiencing a wound leakage.The surgeon took the patient back to the operating room to place a suture in the wound and during this procedure, he found a small, clear piece of material in the wound.During the sixth day postoperative visit after the second procedure, the surgeon indicated the patient is doing well, the eye was quiet and the wound was secure.

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of phaco needle broke off in eye, wound leak and foreign material retained; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot record reviews could not be conducted.A sample was not received at the manufacturing site and no lot information was provided; therefore, the root cause for the customer complaint issue cannot be determined.The exact root cause for this complaint is unknown; therefore, specific action with regards to this complaint cannot be taken.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.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: 9387156
• MDR Text Key: 168434073
• Report Number: 1644019-2019-00184
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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?: No
• Date Manufacturer Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention