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

Catalog Number ASKU

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

Patient Problems Endophthalmitis (1835); Hypopyon (1913)

Event Date 08/07/2020

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.(b)(4).

Event Description

A customer reported a patient experienced endophthalmitis.Additional information has been requested and received indicating the patient experienced inflammatory response endophthalmitis following a vitrectomy procedure.The patient presented post operative day one with conjunctival inflammation, aqueous cell, hypopyon and fibrin in the right eye.Cultures were performed and the patient required intravitreal injections of antibiotics.Steroid and antibiotic eye drops were also prescribed.The patient's symptoms have resolved.This is one of several reports for this facility.

Manufacturer Narrative

Corrected information has been provided in b.2.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Corrected information has been provided in h.1.- "summary report".The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The lot complaint history and dhr were not reviewed, as no lot information was available for this complaint.The sample was not received at the investigating site for this complaint report.Visual inspection or functional testing could not be conducted.If a sample is returned at a later date, the investigation will be reopened and the sample will be evaluated.The root cause of the customer's complaint could not be established, as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.The manufacturer internal reference number is: (b)(4).

• 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: 10926995
• MDR Text Key: 218912169
• Report Number: 1644019-2020-00634
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AKREOS AO 60 LENS; ALCON BSS; CONSTELLATION VISION SYSTEM; POVIDONE IODINE; PROVISC; AKREOS AO 60 LENS; ALCON BSS; CONSTELLATION VISION SYSTEM; POVIDONE IODINE; PROVISC
• Patient Outcome(s): Other; Required Intervention