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

Model Number TABLETOP

Device Problems Infusion or Flow Problem (2964); Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Eye / Vision Problem (4471)

Event Date 07/19/2021

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 health professional reported that injection was not functioning in an ophthalmic operating console.Procedure details and patient impact have not been provided. the surgery was completed.Additional information has been requested.Additional information received indicated that the test of the machine was good, the pressure was within standards.During the beginning of the vitrectomy surgery, when they started the infusion without running the vitrector, it flowed correctly but when the vitrector was run, the infusion did not compensate, so the eye became very soft.Then they changed the tubing of the infusion (green tubing), and completed the surgery.No system message was displayed.The surgeon filled the eye with dk-line to avoid any problems.

Manufacturer Narrative

The customer called, the company representative to assist with troubleshooting.The customer was able to resolve the issue remotely.With no additional, related information provided, the customer reported event was not confirmed.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 12354405
• MDR Text Key: 267698326
• Report Number: 2028159-2021-00925
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• Combination Product (y/n): N
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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?: No
• Date Manufacturer Received: 09/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1