MAUDE Adverse Event Report: ALCON RESEARCH, LLC - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065751058

Device Problem Leak/Splash (1354)

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

Event Date 12/02/2018

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 surgeon reported two cassettes were found to have leakage at their interface before surgery.There was no patient involvement.This is one of three reports for this surgeon.

Manufacturer Narrative

Additional information provided.The lot complaint history was reviewed; this is the second complaint for the finish goods lot and second for this issue for this lot.The device history record shows the product was released per specifications.A sample for this complaint report has not been received; visual inspection or functional testing could not be conducted in order to ascertain the failure mode for the consumable device.The root cause of the customer's complaint could not be established as a sample has not been received.Without analysis of the sample, it is not possible to isolate the root cause.As the root cause is unknown, the relationship, if any, of the device to the reported incident cannot be determined.After an investigation of this complaint, it has been determined that no action will be taken at this time as a sample was not returned and a root cause evaluation could not be performed.Manufacturing 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).

Manufacturer Narrative

Additional information provided.Two samples were returned and evaluated.An elastomer air burst test was performed on each sample and both functioned within specifications.A calibrated console was used to test each sample.Sample 1 - the sample could prime, and pass intraocular pressure (iop) calibration successfully.However, during priming fluid leakage was observed between the red connector on the administration manifold while it was connected to the cassette port.The administration manifold was replaced with one from labstock and the sample could then pass priming and iop calibration successfully.There appeared to be extra connector material on the red connector interfering with the full engagement of the connector to the cassette.Sample 2 - the sample could prime, and pass iop calibration successfully.No anomalies were observed during priming.No system message code was generated during testing.No leakage was detected from the manifolds, connectors, or drain path between the consumable and console.After functional testing no leakage was detected from the pump elastomer or on the pump area of the fluidics module.The most likely root cause of the customer's complaint is related to an error during the supplier manufacturing process of the red connector.Quality engineering materials will notify the supplier of the complaint per procedure.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LLC - HOUSTON; 9965 buffalo speedway; houston TX 77054
• MDR Report Key: 8165298
• MDR Text Key: 130481134
• Report Number: 1644019-2018-00289
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K880961
• 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: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: 8065751058
• Device Lot Number: 2073274H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Date Manufacturer Received: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK