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

Catalog Number 8065752202

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

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

An operating room assistant reported that the ultrasound tip broke during the phacoemulsification phase of a cataract procedure.The surgeon retrieved the broken tip.The tip was replaced and the procedure was completed.There was no patient impact.

Manufacturer Narrative

Additional information provided in d.10, h.3, h.6 and h.10.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 phaco tip was visually inspected and deemed nonconforming, the phaco tip is broken at the cone to cannula transition, remaining tip was not returned.The break is not jagged.The wall thickness is uneven, with a very thin wall.The complaint evaluation confirms the phaco tip is broken.The reason for breakage is due to a uneven wall thickness creating a weak region at the thinner section.The uneven wall thickness is a manufacturing issue created at the machining process for the phaco tips.An investigation photo of the returned broken phaco tip has been issued within the learning management system for review with the applicable production personnel to raise awareness of this issue.Operators control both the part concentricity and inside/outside diameter of the cannula to insure the wall thickness is manufactured to specification.All phaco tips are 100% visually inspected by trained operators using 30x magnification throughout the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No additional action is required at this time.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: 9349762
• MDR Text Key: 182624373
• Report Number: 1644019-2019-00178
• 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: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 8065752202
• Device Lot Number: 2248927H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 01/19/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK