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

Model Number TABLETOP-JAPAN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2019

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 surgeon reported the black tube came off the vitrectomy probe when it was actuated and air sound was hear during a procedure.The product was replaced with another one and the procedure was completed.There was no harm to the patient.

Manufacturer Narrative

The lot complaint history was reviewed; this is the first complaint for the finish goods lot and first for this issue for this lot.The device history record shows the product was released per specifications.Microscopic examination of the returned sample showed the aspiration tubing end that is inserted into the probe engine port did not contain adhesive residue.This issue will result in the customer's experience of "tube came off from probe." a review of the process determined the absence of adhesive likely occurred during the manual assembly of the tubing to the probe engine.The event most likely occurred during the manual application of adhesive and insertion of the tubing to the probe engine.Each probe assembly undergoes visual inspection and is tested for actuation, aspiration, and cut during manufacturing.As part of the normal production process, each probe is leak and flow tested to ensure the product was built correctly which includes the bonding process of the tubing to the probe engine was performed per specifications.If an assembly fails the leak and flow test, the unit is rejected.The root cause of the customer's complaint is related to an error during manual application of adhesive and insertion of the tubing 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.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: 8798842
• MDR Text Key: 151440476
• Report Number: 2028159-2019-01301
• 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: 10/31/2019

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-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/17/2019
• Supplement Dates Manufacturer Received: 10/23/2019
• Supplement Dates FDA Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK