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

Catalog Number 8065752437

Device Problem No Device Output (1435)

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

Event Type  malfunction  

Event Description

An ophthalmic surgeon reported bss (balanced salt solution) continued to flow from the infusion after switching to liquid air displacement during the procedure.The pak was replaced and the procedure was completed.The procedure type was not known.There was no patient harm.Additional information received from the company representative indicated that switching of liquid/air displacement function did not work and water kept flowing during the procedure.

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

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.The 25+ga (gauge) pak was visually inspected.The pos 3 identification (id) tab was broken off on the pinch plate of the cassette that interfaces with the console.This observed damage will result in the customer's experience.Inspection of the pinch plate indicates the tab likely broke off at some point, however, we were unable to isolate when and where the break occurred.We were able to replicate the customer's experience.During fa/x function, fluid (instead of air) flowed to the infusion cannula line.There was no fluid from the low-pressure air source (lpas) port of the cassette to the infusion cannula line.Console safety checks are established to detect and prevent the reported cassette from being used by the customer.The root cause of the customer's complaint could not be conclusively determine when and where the broken id tab on the pinch plate occurred.No corrective action is required at this time, based on our current tracking, there are no adverse trends for this reported complaint and lot.In-process controls are established to ensure each final assembled pak 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: 16086778
• MDR Text Key: 308458208
• Report Number: 1644019-2023-00010
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524372
• UDI-Public: 00380657524372
• 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: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 8065752437
• Device Lot Number: 14HE2F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM