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

Catalog Number 8065752450

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

Patient Problem Endophthalmitis (1835)

Event Date 03/27/2020

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 surgeon reported observing a patient with postoperative endophthalmitis.This is one of two reports from this surgeon.

Manufacturer Narrative

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 suspect product was discarded and therefore a full evaluation was unable to be performed.A review of the finished goods lot indicates this report to be an isolated incident for this lot.All procedure paks are single-use devices provided to the customer in a sterile manner.A non-suspect sample was returned and visually and functionally tested.No obvious defects or physical was observed that would have contributed to the reported event.The sample was functionally tested on a calibrated console and met specifications and functioned as intended.The root cause of the customer's complaint could not be established as a sample has not been received and therefore 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.All procedure paks are single-use devices provided to the customer in a sterile manner.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information provided in b.5.The manufacturer internal reference number is: (b)(4).

Event Description

Additional information received from the surgeon who indicated there was no causal relationship between the patient's endophthalmitis and the products, that the event was caused most likely by human factors.No other information will be available.

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 10015468
• MDR Text Key: 189564601
• Report Number: 1644019-2020-00231
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 8065752450
• Device Lot Number: 2337308H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM.
• Patient Outcome(s): Other