MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LAUREATE WORLD PHACO SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750502

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

Patient Problem Unspecified Infection (1930)

Event Date 07/19/2019

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 customer reported having a patient with endophthalmitis postoperatively and the customer believes this is related to white crystals powder residue left on the fluidic module on the console secondary to the cassettes leaking the past.

Event Description

Laboratory testing of the other instruments used yielded no "suspicious" findings.A company representative found white crystals on the fluidics module.The customer has sent this sample for laboratory testing.This is one of two reports for this surgeon.

Manufacturer Narrative

The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

No sample has been returned for evaluation; therefore, the condition of the product could not be verified.No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted.All lots are verified that all required tests have been performed and all acceptance criteria were met.No image was provided of fluid leakage from the cassette.Images of the fluidics module (inner shell) were provided by the customer which showed a white powder-like residue on the fluidics module (inner side).We could not ascertain from the images the failure mode for the consumable cassette.The root cause of the customer's complaint could not be established as a sample has not been received and the condition of the product could not be verified.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 root cause for this complaint is not known, therefore, specific action with regards to this complaint cannot be taken.The manufacturer internal reference number is: (b)(4).

• Brand Name: LAUREATE WORLD PHACO SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8892711
• MDR Text Key: 154268364
• Report Number: 2028159-2019-01492
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K021566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750502
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LAUREATE SURGICAL PROCEDURE PAK; LAUREATE SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other