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

Model Number TABLETOP-JAPAN

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/30/2018

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 leakage from the side of the cassette was observed during a procedure.The procedure was completed after replacing the product with another one.There was no harm to the patient or operating room staff.No additional information is expected.

Manufacturer Narrative

Additional information provided.The lot complaint history was reviewed, this is the third complaint for the finish goods lot; however, the second for this issue for this lot.The device history record shows the product was released per specifications.One wet combined cassette with the attached drain bag was visually inspected.The pump elastomer was internally lifted at the drain ports region.The check valve area of the drain bag was completely sealed.The drain bag was cut for further investigation.An extra layer of the film was sealed on the check valve of the drain bag.Inserting a blue tie into the inlet check valve to detect the flow path, the seal of the film completely block the entrance of the drain bag.The blockage of the inlet check valve prevented fluid from flowing to the drain bag, and caused elevated back pressure and ultimately, leakage at the pump area/elastomer of the fluidics module.The drain bag was replaced with lab stock along with components that were not returned from the lab stock, the sample was tested using the console.No message code appeared on the screen.No bubble was detected in the non invasive flow sensor (nifs) fluid path.No leakage was found from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test was completed the root cause of the customer¿s complaint is believed to be an error that occurred during the supplier¿s manufacturing process.The supplier has been made aware of the issue; however, as the occurrence rate for this failure is low and this appears to be an isolated incident, no formal root cause or corrective action has been requested.Quality assurance will continue to monitor and will take action for future occurrences as deemed necessary.Consumables manufacturing has also been made aware of the issue through the monthly complaint review meeting.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7448894
• MDR Text Key: 106302643
• Report Number: 2028159-2018-00815
• 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: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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
• Other Device ID Number: 380657518173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Date Manufacturer Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other