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

Catalog Number 8065751613

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/09/2023

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 customer reported that the irrigation tube stopped working and the problem had occurred on multiple occasions with different doctors but all with the same products.The tech ended up taping the tubing straight down to the machine during the first incident and it worked but when it happened again that did not work, so another irrigation tubing was used which also did not work.So, the cassette was changed to a different cassette, and everything worked fine.It was also reported that the irrigation stopped working during the middle of the case.It did not cause any harm, but the doctors were very concerned that it would.No errors popped up on the machine during the surgery.

Event Description

Additional information was received from the company representative indicating that there were multiple incidents where the eye collapsed during surgery due to the irrigation tubbing issues.

Manufacturer Narrative

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 customer reported irrigation tubing did not work when using a posterior cassette configuration.This type of cassette does not have an irrigation tube, but does contain a liquid infusion tube.The customer likely meant infusion.The returned samples were visually inspected and no obvious defects were found.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated constellation console representing the current software version was used to test the samples.The light emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass intraocular pressure (iop) calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.The infusion pressure was measured at multiple setpoints throughout the console range and met specifications.Fluid flowed from the balanced salt solution (bss) bottle to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.The customer should be reminded that the directions for use (dfu) states to visually confirm that adequate air and fluid infusion flow is occurring prior to attachment of the infusion cannula to the eye.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Based on our current tracking, there are no adverse trends for this reported complaint and lot.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: 16530118
• MDR Text Key: 311156521
• Report Number: 1644019-2023-00252
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657516131
• UDI-Public: 00380657516131
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2023

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: 07/31/2024
• Device Catalogue Number: 8065751613
• Device Lot Number: 1502HC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 02/22/2023; 05/19/2023
• Supplement Dates FDA Received: 03/23/2023; 06/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1