MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Catalog Number 8065750833

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

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.(b)(4).

Event Description

A customer reported the system was locked prior to a surgical procedure.There was no patient involvement.Additional information is not expected.

Manufacturer Narrative

The company service representative examined the system and was able to replicate the reported event.The nonconforming central processing unit (cpu) host module was replaced.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the nonconforming central processing unit (cpu) host module.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The cpu-host was received for evaluation.A visual assessment of the returned sample, found there were no visual non-conformities.The returned sample was installed into a calibrated system, but the system was not able to load past the logo screen.It was found that the hard drive was missing.The system was rebooted with a hard drive from the calibrated system installed and system message (sm) displayed.The pcb was found to be nonconforming.The root cause of the reported event can be attributed to the printed circuit board (pcb) within the host.The manufacturer internal reference number is: (b)(4).

• Brand Name: INFINITI VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 8479956
• MDR Text Key: 140962718
• Report Number: 2028159-2019-00600
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K120912
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1