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

Catalog Number 8065000095

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Endophthalmitis (1835)

Event Date 03/06/2023

Event Type  Injury  

Event Description

A physician reported that endophthalmitis developed on (b)(6) 2023 after vitrectomy surgery on (b)(6) 2023.The surgery was not performed again, and the patient was under observation.The sample was not available for return.This report is 1 of the 4 reports.Additional information received from the physician, the patient experienced endophthalmitis in the left eye which led to the hospitalization.The event was treated with antibacterial drugs, eye drops, and an infusion, and the patient was recovering.The changed washing procedure was considered a possible factor.

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.The adhesive sealing transfer was inspected and measured on the flanged surface and the sealing residue was observed to be continuous and within specifications.Further inspection found no internal or external damage to the components, tyvek, or container tray.No anomalies were observed.A blue-dye seal test was performed on the returned sealed tray.No breaches in the sterile barrier between the tray and tyvek were observed.The sample passed testing and the sterile barrier was found to meet specifications.The system is a closed system.It is operated with a sterile single use consumable cassette, which is designed to isolate the patient fluid path from the console itself.Any reusable surgical instrumentation (e.G.Phaco handpiece) that would come into contact with the patient would be autoclaved by the user prior to surgery, per standard industry practices and the product directions for use (dfu).There is no evidence that the design or performance of the console caused or contributed to this reported event of endophthalmitis.The root cause of the customer's reported event could not be established as the sterile barrier was intact and seal met specifications.No action will be taken for this occurrence as the returned product met specifications.Current tracking indicates no adverse trend for this lot for this event.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.The consumable single-use cassette and pak is provided to the customer in a sterile manner.An evaluation is conducted to ensure each requested item meets customer, process, and regulatory requirements.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: 16690769
• MDR Text Key: 312792406
• Report Number: 1644019-2023-00381
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380650000958
• UDI-Public: 00380650000958
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2024
• Device Catalogue Number: 8065000095
• Device Lot Number: 14Y833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 06/21/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention