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

Model Number TABLETOP-JAPAN

Device Problem Air Leak (1008)

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

Event Date 04/10/2018

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.The manufacturer internal reference number is: (b)(4).

Event Description

A doctor reported that a large amount of air was mixed from the infusion line during a procedure.The product was replaced and procedure completed with no patient harm.A product sample has been requested, however, it has not been received for evaluation at the manufacturing site.

Manufacturer Narrative

Additional information provided.The lot complaint history was reviewed, this is the eighth 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 used returned sample was visually inspected and surgical residue and balance salted solution (bss) crystal was in the fluid path of the manifolds.The sample was fully tested on a calibrated console.The sample could prime, tune, and pass intraocular pressure calibration successfully.The infusion pressure, irrigation, and aspiration rate were all measured at multiple set points throughout the console range and met specifications.Fluid was able to flow from the bss bottle to the drain bag.Toggling the infusion and the fluid/air exchange (f/ax) modes, fluid and air flowed from the cassette to the infusion line continuously without any bubble in various settings in all sub modes.No message code appeared on the screen during functional testing.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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7471877
• MDR Text Key: 106972631
• Report Number: 2028159-2018-00871
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

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: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2018
• Initial Date FDA Received: 04/30/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other