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

Model Number LXT

Device Problems Crack (1135); Leak/Splash (1354)

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.(b)(4).

Event Description

A nurse reported that a cracked cassette resulted in balanced salt solution leakage during a retinal procedure.The surgeon continued the procedure since it was not causing a problem with the case; they used three balanced salt solution (bss) bags to complete the procedure.There was no patient harm.

Manufacturer Narrative

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.The sample was visually inspected and no obvious defects were found.No crack was observed on the cassette, the aiv, the drip chamber and the connectors.The infusion cannula line and the yellow stopcock were not returned.A full cassette leakage test was performed using an external pressure source and no leakage was detected.The cassette was then evaluated on a calibrated constellation console and could prime and pass intraocular pressure (iop) calibration successfully.No leakage or anomalies were observed during functional testing.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.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: 8772533
• MDR Text Key: 150567243
• Report Number: 2028159-2019-01250
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/10/2019

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: LXT
• Device Catalogue Number: 8065751145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Manufacturer Received: 06/20/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALANCED SALT SOLUTION (BSS); CONSTELLATION SURGICAL PROCEDURE PAK; CUSTOM-PAK SURGICAL PROCEDURE PACK