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

Catalog Number	8065751614
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported after the loading of the trocars on the sclera it was noticed that all trocars for the instrumentation had a big leakage during vitrectomy surgery.The operation was completed successfully with some difficulties since the doctor was using a contact lens as inverter and the balance salt solution (bss) coming out from the trocar was falling on the lens resulting in blurry lens.Additional information received from company representative that there was no harm occurred to the patient.Also it was clarified that the lens was blurry through out the procedure.
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).
Additional Manufacturer Narrative
Two opened trocar assemblies in a tray were received.The samples were visually inspected and found to be nonconforming, sample #1 had an opened septum.Sample #2 had a damaged septum with an angled slit.Leak testing could not be performed due to the open septum and damage of the returned samples.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.The sample evaluation confirms damage to the septum's.The root cause for why the septum on sample #1 remains open cannot be determined; however a supplier or manufacturing related issue cannot be ruled out.Samples #2, the exact root cause for this complaint is unknown; the damaged condition of the valve could have contributed to the reported event; how and when the valve became damaged cannot be determined from the evaluation performed.An investigation is currently in progress in order to further investigate issues with the trocar opened septum on sample #1.Samples #2 the exact root cause for this complaint is unknown therefore specific action for this complaint cannot be taken.An acceptance quality inspection is performed to ensure product meets release acceptance criteria.This inspection includes evaluation for damaged valves.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.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: 16661856
• Report Number: 1644019-2023-00346
• Device Sequence Number: 6615815
• Product Code: LRO
• UDI-Device Identifier: 00380657516148
• UDI-Public: 00380657516148
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 05/31/2024
• Device Catalogue Number: 8065751614
• Device Lot Number: 14R44D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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