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

Catalog Number 8065752438

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/02/2023

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 physician reported perfusion fluid could not completely enter the perfusion cavity, resulting in low intraocular pressure of patient during surgery.Cassette was replaced and surgery was completed with no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed.This is the tenth complaint for the finished goods lot; however, this is the first complaint for this issue for this lot.The device history record (dhr) shows the product was released per specifications.The returned sample was visually inspected, and no obvious defects were found.The ball in the drip chamber¿s check valve moved freely, per specification.The non-invasive flow sensor (nifs) on the cassette housing was in good condition.A calibrated console representing the current software version was used to test the sample.The sample could prime, tune, and pass iop calibration successfully.The infusion pressure was measured at multiple set points and met specifications.Toggling the infusion and the fluid/air exchange (fax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubbles in various settings in all sub modes.The sample was able to pass all functional and performance testing.The sample met the specifications.No system message code was generated during testing.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 in the pump area of the fluidics module.The cleaning process was able to be performed after the functional test had been completed.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After an investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor the 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: 16467392
• MDR Text Key: 310967320
• Report Number: 1644019-2023-00206
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524389
• UDI-Public: 00380657524389
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• 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: 8065752438
• Device Lot Number: 14E5N6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1