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

Catalog Number 8065752200

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

A product sample was received and it is awaiting evaluation.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 nurse reported that the phaco tip broke in the patients eye during a procedure.The sleeve held the needle.The product was replaced and the procedure was completed.Patient outcome is unknown.Additional information has been requested.

Manufacturer Narrative

A review of the device history records traceable to two possible lot numbers indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination indicates there were no additional complaints associated with the lot for the reported issue.A visual inspection of the phaco tip received was performed and deemed nonconforming.The tip is broken at the transition between the cone and cannula.The wall thickness at the break area is uneven, resulting in the thin wall section.The complaint does confirm the phaco tip is broken.The reason for the breakage is due to a nonconforming thin wall present at the break area.This thin wall is a manufacturing issue created at the machining process for the phaco tip.A photo of the broken phaco tip section was shown to machine operators to make then aware of this complaint issue for a thin wall and the importance of controlling the process to insure a good wall thickness is obtained.Operators control both the part concentricity and inside and outside diameter of the cannula to insure the wall thickness is manufactured to specification.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: 8422073
• MDR Text Key: 138995008
• Report Number: 1644019-2019-00034
• Device Sequence Number: 0
• Product Code: LRO
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Date Manufacturer Received: 04/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK