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 Consequences Or Impact To Patient (2199)

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 air entered the infusion line during a surgery.The product was replaced and the procedure was completed without harm to the patient.A product sample has been requested for evaluation.

Manufacturer Narrative

The lot complaint history was reviewed; a device history review (dhr) shows that the product was released per specifications.The returned sample was visually inspected and no obvious defects were found.It was noted the irrigation and aspiration tubing was not returned.A reverse leakage test was performed on the auto infusion valve (aiv) and no leakage into the air infusion line was detected.A console representing the current software version was used to test the sample.The light emitting diode (led) rings on the console turned green as the probe connectors were engaged to the console indicating the proper communication between the probe and the console.The ball in the check valve of the drip chamber moved freely per specification.The sample could prime and pass intraocular pressure (iop) calibration successfully.The infusion pressure, irrigation, and aspiration rate were all measured at multiple set points throughout the console range and met specifications.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.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test had completed.No air entered the infusion line during functional and performance testing.The root cause of the customer's complaint could not be established; the returned sample met specifications.The auto infusion valve functioned per specifications during f/ax mode.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6171487
• MDR Text Key: 62601904
• Report Number: 2028159-2016-05697
• 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: 05/03/2017

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: 3.00.61
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2014
• 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
• Treatment: COMBINED PACK
• Patient Outcome(s): Other