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

Model Number TABLETOP

Device Problems Overheating of Device (1437); Device Inoperable (1663)

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

Event Date 03/15/2018

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 healthcare professional reported that the light source was heating and did not work during a surgical procedure.The procedure was completed with no harm to the patient.

Manufacturer Narrative

Additional information is provided.The system was examined and the reported event was replicated.The illuminator was replaced to resolve the issue.The system was tested and found to meet product specifications.The system was manufactured on january 2, 2013.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to nonconforming illuminator how or when it became nonconforming could not be determined.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

The illuminator module was received and a visual assessment of the returned sample did not show any non-conformities.The sample was installed in a calibrated vision system and was tested.The illuminator module met product specifications.The root cause could not be determined.The illuminator module functioned as intended.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: 7422130
• MDR Text Key: 105385229
• Report Number: 2028159-2018-00733
• 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,Followup
• Report Date: 04/08/2019

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: 01/03/2019
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/11/2018
• Supplement Dates Manufacturer Received: 06/12/2018; 04/02/2019
• Supplement Dates FDA Received: 06/27/2018; 04/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other