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

Catalog Number	8065751766
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A nurse reported that there was a leak observed inside the cassette at the infusion connector and also the balanced salt solution (bss) kept falling from the bss bottle through the spike connector into the drip chamber during vitrectomy surgery.There was no error or advisory message was displayed on the screen.The surgery was completed after replacing the cassette with new one.The patient harm was not reported.
Additional 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, no obvious defects were found.The ball in the drip chamber¿s check valve moved freely per specification.A submerge leak test was performed on the cassette, no leakage was observed.A console representing the current software version was used to test the sample.The sample primed and passed intraocular pressure (iop) calibration successfully.Fluid flowed from the balanced salt solutions (bss) bottle to the drain bag without any interfering.No message code appeared on the screen.Fluid was introduced to the drain bag.No leakage was found from the drip chamber, the connectors, the cassette, the drain bag, the manifold, the pump elastomer or onto the pump area of the fluidics module.Cleaning process was able to be performed after functional test was completed.The sample passed functionality.The root cause of the customer's complaint could not be established; the returned sample met specifications.No contributing factors could be identified that could cause the customer¿s experience.After the investigation of this complaint, it has been determined that this sample met specifications.In-process controls are established to ensure each final assembled cassette is verified that all required tests have been performed and all acceptance criteria are met prior to release.Quality assurance will continue to monitor customer complaints via the complaint review meetings and will take action for any future occurrences as is deemed necessary.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PACK
• Common Device Name: 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: 16988589
• Report Number: 1644019-2023-00610
• Device Sequence Number: 6829207
• Product Code: LRO
• UDI-Device Identifier: 00380657517664
• UDI-Public: 00380657517664
• Combination Product (Y/N): N
• Initial Reporter Country: CY
• PMA/510(K) Number: K880961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: 8065751766
• Device Lot Number: 2531965H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSTELLATION VISION SYSTEM
• Patient Sex: Unknown