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

Catalog Number 8065752192

Device Problem Device Fell (4014)

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

Event Date 02/28/2020

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 customer reported the tip fell into a patient's eye during a procedure.No details concerning the procedure details and patient's outcome at this time.

Manufacturer Narrative

A sample was not received.The report of piece chipped off the phaco tip cannot be confirmed in the photo attached to the parent complaint, damage on the phaco tip bevel and foreign material is confirmed based on the photo attached to the parent complaint.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.Based on the photo attached to parent complaint is confirmed damage on the phaco tip bevel and foreign material, which can be perceived as the phaco tip chipped.However, because a sample was not received and the device history record review of the lot number provided indicated the product was released to the product¿s acceptable criteria, 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).

Manufacturer Narrative

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

Event Description

Additional information received from the surgeon.The surgeon reported a metallic piece chipped off from the phaco tip during a cataract procedure.The chip was observed on the iris at the end of the quadrant removal phase of the procedure and it was safety removed.The procedure was completed and there was no harm to the patient.

• 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: 9788498
• MDR Text Key: 185010966
• Report Number: 1644019-2020-00123
• 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: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 8065752192
• Device Lot Number: 2299913H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1