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 03/07/2023

Event Type  Injury  

Event Description

A physician reported that postoperative endophthalmitis was confirmed at consultation on (b)(6) 2023 after vitrectomy surgery on (b)(6) 2023.The vitrectomy surgery was performed again.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 (dhr) traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A review of the dhr for the reported suspect product also confirms that this product has been sterilized and all sterilization cycle parameters were verified for acceptability prior to release.No sample was returned for root cause evaluation therefore the condition of the product could not be verified.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 complaint could not be conclusively determined as a sample was not received and the condition of the product could not be verified.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.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 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: 16690633
• MDR Text Key: 312790916
• Report Number: 1644019-2023-00378
• 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
• 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?: No
• 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?: Device Not Returned to Manufacturer
• 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): Required Intervention; Hospitalization