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

Model Number LXT

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2019

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.(b)(4).

Event Description

A customer reported that the laser stopped during a retinal detachment repair procedure.The laser was reactivated multiple times.The procedure was completed without harm to the patient.

Manufacturer Narrative

The system was examined and the reported event was confirmed (via event log review).The company representative replaced the printed circuit board (pcb) interface and the footswitch assembly to resolve the issue.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.(pcb) interface and the footswitch assembly were received for evaluation.A visual assessment of the returned samples showed no obvious non-conformities.The samples were installed into a calibrated system and tested for laser function.The reported event was replicated, as the laser footswitch would intermittently disconnect, triggering the laser safety mechanism, exiting the ready mode.This changes to ¿standby mode¿ when the main pedal is depressed/released (with minimal movement between the ¿threshold of firing¿ and ¿not firing,¿ known as ¿feathering¿ method).The laser footswitch was disassembled and the main pedal switch was confirmed to be omron switch.The root cause of the reported event can be attributed to the ¿feathering¿ used with omron switches in the footswitch assembly.An internal investigation was opened for this issue.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: 9110309
• MDR Text Key: 165609742
• Report Number: 2028159-2019-01741
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXT
• Device Catalogue Number: 8065751550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 12/02/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1