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

Model Number LXT

Device Problem Fluid/Blood Leak (1250)

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

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 customer reported that the cassette was leaked and poured on device before surgery.The product was replaced and procedure completed with no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed.This is the third complaint for the finished goods lot; however, this is the first complaint for this issue for this lot.The device history record shows the product was released per specifications.No sample was received for this investigation.However, photos were provided by the customer.The photos were reviewed.A partial lift of the infusion elastomer was visible.Fluid along the side of the cassette by the infusion elastomer and infusion chamber was visible.However, the origin of the fluid could not be confirmed.A cassette from lab stock was used to attempt a replication of the reported event using a calibrated console representing the current software version.The infusion elastomer on the cassette's pinch plate was partially lifted and then inserted into the console.The cassette was able to latch onto the console and be recognized by the console.No message code appeared on the screen.The cassette was then unlatched from the console and visually inspected.The infusion elastomer was no longer lifted.A full evaluation was unable to be performed as no sample was returned and the photos provided could not conclusively establish a root cause of the customer's reported complaint.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 no root cause could be established.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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7728041
• MDR Text Key: 115468448
• Report Number: 2028159-2018-01599
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• 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?: No
• Date Manufacturer Received: 10/09/2018
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other