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

Catalog Number 8065752451

Device Problem Fluid/Blood Leak (1250)

Patient Problem Retinal Injury (2048)

Event Date 10/01/2021

Event Type  Injury  

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 while indenting the globe a fresh retinal foramen was found.The foramina were treated with laser the eye was supplied with gas and patient had to camp.No hospitalization was required.The postoperative course was uncomplicated.Additional information received from the company representative indicating during the surgery all the 27g and 25g trocars were spontaneously leaking immediately after insertion leaked out of the valves.There were multiple products reported from the site and it is still unknown if this actual product is associated with the complaint.This report is third of the of three reports.This one represents the 25 gauge valved trocars.

Manufacturer Narrative

Additional information provided in h.6.And h.10.A sample was not received at the manufacturing site for evaluation; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.A sample was not received at the manufacturing site and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, therefore; the root cause for the customer complaint issue cannot be determined.Investigations have been completed and manufacturing process enhancements have been implemented in order to improve the performance of the valves.Complaints are reviewed and monitored at regular intervals to evaluate effectiveness of actions taken.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 PAK
• 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: 14014492
• MDR Text Key: 288606283
• Report Number: 1644019-2022-00253
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524518
• UDI-Public: 00380657524518
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 8065752451
• Device Lot Number: 2362495H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CUSTOM PAK, BEL
• Patient Outcome(s): Required Intervention
• Patient Sex: Male