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

Model Number TABLETOP

Device Problem Device Inoperable (1663)

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

Event Date 04/28/2018

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 lamp burned out during a vitrectomy procedure.The surgery was not completed.Additional information has been requested.

Manufacturer Narrative

Additional information is provided.The company service representative examined the system, but did not indicate replicating the reported event.The illuminator module was replaced.Unrelated to the reported event the system software was upgraded.The system was then tested and met all product specifications.The system was manufactured on october 20, 2014.Based on qa 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).

Manufacturer Narrative

The illuminator was received for evaluation.Upon functional testing, system message (sm) was displayed.Further evaluation found a nonconforming illuminator tied to the root cause.The root cause of the reported event can be attributed to nonconforming illuminator.However, how or when it became nonconforming could not be determined.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: 7531681
• MDR Text Key: 108990135
• Report Number: 2028159-2018-01059
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

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
• Other Device ID Number: 380657511501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 04/30/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 07/27/2018; 07/29/2019
• Supplement Dates FDA Received: 08/20/2018; 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other