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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

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 phaco tip broke inside the sleeve during surgery.It caused a small tear at the incision site which required no action.The phaco tip and sleeve were changed and the procedure was completed with no further problems.

Manufacturer Narrative

One opened phaco tip, tip wrench and infusion sleeve in a glassine envelope was received for evaluation.The tip of the phaco was located in the infusion sleeve.The phaco tip was visually inspected and deemed nonconforming, the phaco tip was broken at the aspiration bypass (ab) hole with a very jagged edge.The phaco had even wall thickness.There was wear on the threads, back of the flange and on the nut corners that was consistent with use.The product was processed and released according to the product¿s acceptance criteria.Photos provided were reviewed by the manufacturing site.The photos are of a phaco tip, an infusion sleeve and it appears a piece of phaco tip is inside the infusion sleeve package label and a tyvek, the reported product and lot information is confirmed.The complaint evaluation confirms the phaco tip was broken.The root cause for the broken phaco tip cannot be determined from this evaluation.The phaco tip visual inspection does not show any manufacturing issue that would cause the broken phaco tip.No specific action with regard to this complaint was taken because the root cause for the complaint issue cannot be determined from this evaluation.All phaco tips are 100% visually inspected by trained operators using 30x magnification during the manufacturing process.Any nonconformance, such as the broken phaco tip exhibited on the returned opened sample, is removed from the lot and scrapped.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: 11446488
• MDR Text Key: 240618074
• Report Number: 1644019-2021-00151
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657522002
• UDI-Public: 00380657522002
• 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: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 8065752200
• Device Lot Number: 2362408H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2021
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTURION VISION SYSTEM; CUSTOM-PAK SURGICAL PROCEDURE PACK