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

Catalog Number 8065752450

Device Problems Failure to Cut (2587); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2022

Event Type  malfunction  

Event Description

An ophthalmic surgeon reported the cutter made noise but did not cut when the cutter was used during a surgery.The surgery type was unknown.The surgery was completed after replacing the product.There was no patient harm.Additional information received from the company representative who indicated the aspiration condition of the cutter was unknown.

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).

Manufacturer Narrative

Additional information provided in d.9., h.3., h.6.And h.10.One opened probe was received, without a tip protector, with bent needle, in a bag.However, the reported lot number was expired when the sample was received at the manufacturing site.Therefore, no product evaluation was performed due to the reported functional issue.A review of the device history record traceable to the lot number obtained from the device¿s radio frequency identification (rfid) tag, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was returned and the device history record review of the lot number obtained from the device¿s radio frequency identification (rfid) tag indicated the product was processed and released according to the product¿s acceptable criteria.However, when the sample was received at the manufacturing site it was determined that the device was beyond its expiry date; therefore, a root cause was unable to be determined.No specific action with regard to this complaint was taken by the manufacturing location because the complaint sample exceeded its expiration date when the sample was received at the manufacturing site.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15930690
• MDR Text Key: 305981482
• Report Number: 1644019-2022-01024
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10380657524508
• UDI-Public: 00380657524501
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

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: 12/31/2022
• Device Catalogue Number: 8065752450
• Device Lot Number: 2450840H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/07/2022
• Supplement Dates Manufacturer Received: 03/22/2023
• Supplement Dates FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CUSTOM-PAK SURGICAL PROCEDURE PACK