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

Catalog Number 8065753041

Device Problems Energy Output Problem (1431); Component Missing (2306)

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

Event Date 06/30/2022

Event Type  malfunction  

Event Description

A nurse reported that before a vitrectomy surgery an ophthalmic operating console had issues with laser and the interlock was missing.Procedure was completed using another console.There was no patient involvement.

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).

Manufacturer Narrative

The company service representative, examined the system.And confirmed, the reported system message (sm) in the system event log.However, the company service representative, was unable to replicate the sm, while on-site.As a preventative measure, the company service representative, provided field service test cassette paks to the customer.The system was then tested and met all product specifications.The company service representative, inspected the system for the priming error, but was not aware of the reported laser issue, while onsite.It was learned, that the interlock had been disconnected and unplugged by the staff.The interlock was plugged back in by another technician and proper training to the staff was addressed.The customer cancelled, the request for the laser issue.And there was no further service visit.As of september 27, 2022, the customer has not reported of any further laser issue.A system non-conformance-based review of the batch/lot/serial number was performed and did not reveal, any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed, prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot/batch/serial number was performed.A potentially relevant complaint was found and reviewed as part of this investigation.The complaint was opened to address a lamp illumination issue, tray arm issue, priming issue, and rfid issue.The complaint is in progress at the time of this investigation.The root cause cannot be determined conclusively.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
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 15104297
• MDR Text Key: 297156961
• Report Number: 2028159-2022-01059
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657530410
• UDI-Public: 00380657530410
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/21/2022

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 Catalogue Number: 8065753041
• Device Lot Number: 149CV7
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1