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

Catalog Number 8065750502

Device Problem Loss of Power (1475)

Patient Problem No Patient Involvement (2645)

Event Date 12/19/2019

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 surgeon reported the system shut down on its own prior to a cataract with intraocular lens (iol) procedure.There was no patient involvement.

Manufacturer Narrative

The system was examined and the reported event was not confirmed and replicated.The company representative found that the ac power cable was loose.The cabling was reseated and the system was tested.The system was found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a loose ac power cable.However, how or when the cable became loose remains inconclusive.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: 9516595
• MDR Text Key: 177615196
• Report Number: 2028159-2019-02323
• 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
• Report Date: 02/11/2020

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: 8065750502
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/21/2019
• Initial Date FDA Received: 12/24/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1