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

Model Number TABLETOP-JAPAN

Device Problems Noise, Audible (3273); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

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 physician reported that actuation failure of the cutter occurred and abnormal sound was produced during a procedure.The condition of aspiration is unknown.The product was replaced and the procedure was completed.There was no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed, this is the fifteenth complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.Inspection of the probe found the pneumatic open drive line occluded with adhesive which would prevent actuation of the probe cutter.The occlusion of the open drive line will render the device inoperable (i.E.Unable to cut).The root cause is consistent with a manufacturing error where the driveline likely became occluded during the wetting of the pneumatic tubing with solvent and subsequent insertion to the probe engine.In order to mitigate the occurrence of this type of event, during the manufacturing process, downstream in-process checks after final assembly are utilized to help screen out this type of defect from occurring.An action was opened to determine a root cause and implement appropriate corrective actions for complaints of a similar nature.Quality assurance has isolated and identified the major contributor to be the curing process that occurs during the bonding phase of the tubing to the probe pneumatic ports.Corrective actions have been implemented to optimize the probe assembly process.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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: 8898710
• MDR Text Key: 154887202
• Report Number: 2028159-2019-01503
• 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: 12/09/2019

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: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 07/30/2019
• Initial Date FDA Received: 08/15/2019
• Supplement Dates Manufacturer Received: 12/06/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK