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

Model Number CHINA

Device Problem Unexpected Shutdown (4019)

Patient Problem Unspecified Infection (1930)

Event Type  malfunction  

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 government agency reported that during the cataract surgery with intraocular lens (iol) implantation in the right eye, an ophthalmic console stopped to work.The equipment worked normally after removing the equipment issue, and the surgery could be continued.It was also reported that the patient eye was infected.Additional information has been requested but none received till date.

Manufacturer Narrative

Service history was reviewed for the system.No service record relevant to the complaint reported event was found.However, the system was last serviced prior to the reported event per service record (sr) opened.A non-conformance-based review of the batch/lot/serial number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint was opened to address another shut down event and the root cause was inconclusive after no service records were found.Based on the information obtained, the root cause of the reported event is inconclusive.Manufacturer 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: LAUREATE WORLD PHACO SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16672106
• MDR Text Key: 312947245
• Report Number: 2028159-2023-00402
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021566
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

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 Model Number: CHINA
• Device Catalogue Number: 8065751098
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/25/2023
• Supplement Dates FDA Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female