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

Model Number TABLETOP

Device Problem Optical Problem (3001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/17/2020

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 the illumination ports were too dark.Additional information has been requested and received indicating the event occurred during a cataract extraction procedure.He procedure was completed with no impact to the patient.Service was requested and performed.The system is performing fine.

Manufacturer Narrative

The company service representative examined the system and replicated the reported event.The illuminator module was replaced to resolve the issue.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The illuminator module was received and evaluated.Per the sample evaluation, the issue was replicated.The illuminator controller printed circuit board (pcb) in the illuminator module was found to be nonconforming.The root cause of the reported event can be attributed to nonconforming illuminator controller printed circuit board (pcb) 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: 11047148
• MDR Text Key: 223396333
• Report Number: 2028159-2020-01132
• 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
• Report Date: 06/07/2021

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: 02/25/2021
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 05/28/2021
• Supplement Dates FDA Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1