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

Catalog Number 8065753106

Device Problem No Flow (2991)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

A physician reported that there was no air injected during the vitrectomy surgery.The defect alarm was not displayed.The surgery was completed after replacing the product.There was no patient harm.

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 returned sample was visually inspected and no obvious defects were found.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 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.When the fluid/air exchange (f/ax) control was on, air was not introduced from the cassette to the infusion line.The customer's event was able to be replicated.The auto infusion valve (aiv) manifold was then tested separately.An external pressure source was used to perform an opening pressure test.The pressure was incrementally increased until the valve actuated.The aiv was found to be non-conforming due to the higher-than-expected opening pressure.Since the aiv actuated during initial calibration and did not generate a system message error during setup of the cassette pak, it¿s possible a fraction of the silicone valve lips self-adhered and potentially contributed to the higher than typical cracking pressure observed.The source of the customer's complaint is a sticky auto infusion valve; however, the root cause of the stuck valve could not be conclusively determined.A contributing factor is self-adhesion of the duckbill valve lips based on laboratory testing.Action will not be taken for this occurrence as the exact root cause is not known.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: 16794580
• MDR Text Key: 313812395
• Report Number: 1644019-2023-00459
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657531066
• UDI-Public: 00380657531066
• 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: 08/02/2023

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: 04/30/2024
• Device Catalogue Number: 8065753106
• Device Lot Number: 14MKLU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/24/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM