MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number TABLETOP

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 that the console's table top bulb did not work.

Manufacturer Narrative

Additional information provided.The company service representative examined the system and was able to replicate an issue related to the reported event.The xenon lamp had exceeded its maximum rated life and was replaced.The system was then tested and met all product specifications.The system was manufactured on april 16, 2011.Based on qa assessment, the product met specifications at the time of release.When the xenon lamp reaches 400 hours system message (sm) - ¿the lamp has exceeded its rated life: lamp needs to be replaced.Please contact field service¿ will display.This sm is only an advisory for the user to replace the lamp after it has reached 400 hours and can only be cleared by the user pressing a button on the screen.As the lamp is rated for 400 hours of use, after this time the lamp¿s performance will decrease; however, the lamp can still be used after this system message is acknowledged.The root cause of the reported event can be attributed to the xenon lamp which exceeded its rated life.However, no problem was found with the xenon lamp as it functioned to its expected rated life.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7377113
• MDR Text Key: 103801440
• Report Number: 2028159-2018-00623
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

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: TABLETOP
• Device Catalogue Number: 8065751150
• Other Device ID Number: 380657511501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 03/28/2018
• Supplement Dates Manufacturer Received: 05/21/2018
• Supplement Dates FDA Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other