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

Model Number TABLETOP

Device Problems Computer Software Problem (1112); Intermittent Continuity (1121)

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

Event Date 01/07/2019

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.(b)(4).

Event Description

A customer reported that during a vitrectomy, the system shut down on its own.There was a problem in windows.There was a 40 minute delay.The case was completed without patient harm.

Manufacturer Narrative

The company service representative examined the system, confirmed, and replicated the reported event.The host module was replaced.The system was then tested and met all product specifications.The system was manufactured on july 21, 2011.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 nonconforming host module.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The host module was received and a visual assessment of the returned sample showed no obvious visual nonconformity.The returned part was installed into a calibrated company system and tested.The system was left on overnight for over 12 hours.The hotbed system was able to boot up successfully, and the system did not shut down itself afterwards.Therefore, the reported event was not replicated.The root cause of the reported event can be attributed to a component failure.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION 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: 8293509
• MDR Text Key: 134706225
• Report Number: 2028159-2019-00158
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2020

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 Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Initial Date Manufacturer Received: 01/08/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 04/02/2019; 03/06/2020
• Supplement Dates FDA Received: 04/09/2019; 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1