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

Catalog Number 8065753106

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/01/2023

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 healthcare professional reported that air infusion was not functioning and fluid infusion continued when fluid air exchange was selected during cataract/vitrectomy combination surgery.The surgery was completed after a new pack was opened.There was no patient impact.

Manufacturer Narrative

A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.No sample has been returned for evaluation; therefore, the condition of the product could not be verified.There was also no specific images or evidence provided to ascertain causality and confirm this reported event.Similar cases have found that a fluid/air exchange error may have resulted from a manufacturing related issue, however, without the sample we are unable to evaluate and confirm failure mode and root cause.The root cause of the customer's complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.Current tracking indicates no adverse trend for this lot for this event.In-process controls are established to ensure each final assembled auto infusion manifold is verified that all required tests have been performed and all acceptance criteria are met prior to release.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 18235380
• MDR Text Key: 329327535
• Report Number: 1644019-2023-01729
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657531066
• UDI-Public: 00380657531066
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065753106
• Device Lot Number: 158E21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1