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

Model Number TABLETOP

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

A physician reported that an ophthalmic console exhibited with viscous fluid control not reaching full limit.The procedure details were not reported.There was no report of patient harm.Additional information will be requested.Additional information was received stating that during surgery reported malfunction occurred and the surgery was completed with the same console without any patient harm.

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 representative, was able to replicate the reported event.The pneumatic module was replaced to address the issue.The system was tested and found to meet product specifications.A 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.No similar complaints were reported for the product lot/batch/serial under investigation.The root cause of the reported event was attributed to a nonconforming pneumatics module.Malfunction will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The pneumatics module was received for testing on this investigation.A visual assessment of the returned sample revealed that there was filth.The sample was installed into a system and tested.The sample failed at vfc tests.There was an air leakage found at the l13 venting proportional valve on the utility circuit.The l13 valve was found to be loose.The reported event was replicated.The root cause of the reported event is attributed to nonconforming l3 valve on the utility circuit of the pneumatics module.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: 16469778
• MDR Text Key: 310546705
• Report Number: 2028159-2023-00274
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 00380657511501
• UDI-Public: 00380657511501
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/22/2023; 07/07/2023
• Supplement Dates FDA Received: 04/18/2023; 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1