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

Model Number LXT

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591)

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

Event Date 12/03/2019

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.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that during a combination case irrigation from phacoemulsification pushes back the capsular bag to the point where the trocars leak.The leaking was enough so that the system could not control the intraocular pressure (iop) and an error message was displayed.The case were completed.Patient impact was not noted.

Manufacturer Narrative

No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.The manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The root cause 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: 9557060
• MDR Text Key: 178583913
• Report Number: 2028159-2020-00010
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LXT
• Device Catalogue Number: 8065751145
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VIT PAK