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

Catalog Number ALCUNK00905

Device Problem Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

As the customer did not retain the finished goods lot number, deviation history review and lot history could not be reviewed.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 evaluated.The root cause of the customer's complaint could not be established as a sample has not been received.Without a 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.After the investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned.Based on our current tracking, there are no adverse trends for this reported complaint.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).

Event Description

A non healthcare professional reported that continuous occlusion during cataract surgery.The surgery was completed on the same day.There was no report of patient harm.

• Brand Name: LAUREATE SURGICAL PROCEDURE PAK
• 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: 18730384
• MDR Text Key: 336057994
• Report Number: 1644019-2024-00302
• Device Sequence Number: 1
• Product Code: LRO
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ALCUNK00905
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LAUREATE WORLD PHACO SYSTEM