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

Model Number TABLETOP

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 08/13/2019

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 there was an internal snap heard and then the equipment turned off.

Manufacturer Narrative

The system was examined.The company representative did not mention finding anything that would have contributed to the reported event.However, the power supply was replaced and a preventive maintenance was performed.The system was tested and 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.Additional related information was requested from the company representative.Specifically regarding servicing details.However, there was no communication returned, to date.Based upon the information received (to date), the root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The correct date is august 13, 2019.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: 8966939
• MDR Text Key: 156885195
• Report Number: 2028159-2019-01620
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

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?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 10/25/2019; 04/22/2020
• Supplement Dates FDA Received: 11/11/2019; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR