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

Model Number TABLETOP

Device Problems No Display/Image (1183); Loss of Power (1475); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/29/2020

Event Type  Injury  

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: 2020-75333.

Event Description

A physician reported that during the cataract extraction phase of a combined cataract/retinal procedure on the patient's right eye the system power went out.A system message was displayed (power failure error).The operating room staff verified that all sockets were well inserted and that the electrical panel to which the system was connected was supplying energy correctly.The back up system was brought in and connected.When turned on the system froze on a white screen.The staff attempted to test and restart the system but still it got stuck on the white screen.The surgeon was unable to proceed with the surgery.The patient was hospitalized while waiting for the surgery to be completed.The posterior part of the procedure to repair the detachment could not be completed.Additional information has been requested and received indicating that the posterior portion of the procedure was completed on the following day to repair the retinal detachment.It was reported currently the patient is doing well.This report will represent the first system issue.

Manufacturer Narrative

The customer did not request service for the system.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event of a system shut down cannot be determined conclusively.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: 11186017
• MDR Text Key: 227486042
• Report Number: 2028159-2021-00067
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TABLETOP
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR