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

Model Number TABLETOP-JAPAN

Device Problems Air Leak (1008); Aspiration Issue (2883)

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

An ophthalmic surgeon reported that air got mixed in the aspiration tube during a procedure.Aspiration failure occurred during irrigation/aspiration.The procedure was completed without product replacement.There was no patient harm.

Manufacturer Narrative

The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The returned sample was visually inspected and no obvious defects were found.A console representing the current software version was used to test the sample.The ball in the drip chamber¿s check valve moved freely per specification.The sample could prime and tune with the handpiece successfully.The irrigation and aspiration pressure were measured at multiple set points and met specifications.No message code appeared on the screen.Fluid flowed from the irrigation solution to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.No air mix or failure of aspiration was observed.Cleaning process was able to be performed after functional test was completed.The sample passed functionality.The root cause of the customer's complaint could not be established; the returned sample met specifications.After a thorough investigation of this complaint, it has been determined that this sample met 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, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7534644
• MDR Text Key: 109045179
• Report Number: 2028159-2018-01082
• 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: 08/15/2018

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
• Other Device ID Number: 380657518173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/22/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other