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

Model Number TABLETOP

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2017

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 bubbles from the infusion line occurred when air switched off during a procedure.The product was replaced and procedure completed with no patient harm.Additional information and sample has been requested.

Manufacturer Narrative

The lot complaint history was reviewed, this is the second complaint for the finish goods lot; however, the first for this issue.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 sample could prime and pass intraocular pressure calibration successfully.No anomalies were observed during priming.The infusion pressure was 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.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 will continue to monitor customer complaints via the complaint review meetings, and will take action for any future occurrences as is deemed necessary.Consumables manufacturing management has been made aware of this complaint.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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6384590
• MDR Text Key: 69574313
• Report Number: 2028159-2017-00970
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K101285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2017

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
• Device Catalogue Number: 8065751150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: 06/26/2017
• Supplement Dates FDA Received: 07/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2012
• 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
• Treatment: CONSTELLATION SURGICAL PROCEDURE PAK
• Patient Outcome(s): Other