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

Catalog Number 8065751763

Device Problem Device Sensing Problem (2917)

Patient Problem Burn, Thermal (2530)

Event Date 03/01/2020

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 customer reported three patients experienced "phaco burns" during cataract extraction procedures.The surgeon stated the cooling capacity was not sufficient as if something was not being aspirated correctly.There was no system messages displayed.It is unknown if the system occlusion alarm was heard.Current condition of the patient and whether intervention was required is unknown.This is one of three reports from this facility.Additional information has been requested.

Manufacturer Narrative

The company service representative examined the system and was not able to confirm or replicate the reported event.Unrelated to the reported event, preventative maintenance (pm) was performed.The system software was upgraded.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The system was found to meet specifications; therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: CENTURION 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: 10085094
• MDR Text Key: 207159342
• Report Number: 2028159-2020-00390
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K121555
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065751763
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/07/2020
• Initial Date FDA Received: 05/25/2020
• Supplement Dates Manufacturer Received: 06/18/2020
• Supplement Dates FDA Received: 06/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1