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

Catalog Number 8065752437

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

Patient Problems Bacterial Infection (1735); Corneal Edema (1791); Endophthalmitis (1835); Pain (1994)

Event Date 03/15/2023

Event Type  Injury  

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 Description

A physician reported that endophthalmitis was observed after the surgery.The bacterial infection was also observed from two days of postoperative surgery.The surgery was performed again to curb infection.The patient was not recovering.Additional information received from the physician, the patient experienced endophthalmitis in the right eye, which was observed on 15-03-2023.The type of surgery was a vitrectomy, intraocular lens (iol) removal, and secondary iol implantation.Minimal pain and corneal edema were observed as symptoms.The event was treated with steroids, antibiotics, non-steroidal anti-inflammatory drugs (nsaid), and other drugs.Vitrectomy surgery, explanation, and anterior chamber wash were performed for treatment, and the patient recovered with a persistent condition.The pak was a possible factor.

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).

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 customer attempted to try and figure out the source of the infection and states no other instrument was used apart from the procedure pak.The sterile consumables quality product certificate was reviewed and confirmed batch was sterilized and all sterilization cycle parameters were verified for acceptability prior to release.A review of complaints for this batch confirms this report is an isolated event for this lot.The tray and tyvek were not returned, only the cassette with the tubing manifolds was received.As a result, the condition of the sealing areas on the tray container and tyvek could not be verified.The components received were intact and no anomalies observed during inspection.The root cause of the customer's complaint could not be conclusively determined based on the available information and parts received.We did confirm the finished good batch used by the customer, was sterilized and released per specifications.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: 16753114
• MDR Text Key: 313428020
• Report Number: 1644019-2023-00424
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 00380657524372
• UDI-Public: 00380657524372
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 11/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065752437
• Device Lot Number: 1502FJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male