MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; 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	11/07/2022
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 after the loading of the three trocars on the sclera it was noticed that all trocars had a big leakage during a vitrectomy operation without iol (intraocular lens) implantation.The doctor decided to continue and the operation was completed successfully with some difficulties since the doctor was using a contact lens as inverter and the bss (balanced salt solution) coming out from the trocar was falling on the lens resulting in blurry lens.Additional information was received.¿the doctor was using a contact lens as an inverter and the bss coming out from the trocar was falling on the lens resulting in blurry lens¿ so by ¿blurry lens¿ she was not referring to the patient's physical lens but to the contact lens used by the doctor.This contact lens became blurry from the bss that was coming out from the trocar so the doctor had difficulties to see through the lens." there was no change in the regulatory decision.
Additional Manufacturer Narrative
Two open trocar assemblies in a bag were received for the report of all the trocar had big leakage.The returned samples were visually inspected and were found to be non-conforming with torn septums.Leak testing could not be performed due to the damage of the sample.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 exact root cause for this complaint is unknown; the damaged condition of the valves could have contributed to the reported event; how and when the valves became damaged cannot be determined from the evaluation performed.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 to evaluate effectiveness of actions taken.No adverse trends have been observed associated with the reported product and event.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• 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: 15844134
• Report Number: 1644019-2022-00979
• Device Sequence Number: 5845653
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2023

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): Follow-Up
• Initial Date Received by Manufacturer: 11/10/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 02/21/2023
• 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.; CONSTELLATION VISION SYSTEM.
• Patient Age: 68 YR
• Patient Sex: Male