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

Model Number TABLETOP-JAPAN

Device Problem Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2019

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.A product sample has been shipped; however, it has not been received for evaluation at the manufacturing site.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that a cutter could not actuate during use after test.The condition of aspiration is unknown.The surgery was completed after replacing the product with another one.There was no patient harm.

Manufacturer Narrative

Two opened probes were received in a tray for the report of actuation failure and abnormal noise.Per follow up details, the probe still attached to the cassette is not the complaint probe, the other probe will be evaluated as part of this investigation.The sample was visually inspected and found to be non-conforming with orange/brown foreign material on the port face and welded cap.The probe was then functionally tested for actuation, aspiration, and cut and was found to be conforming for all three functional tests.No noise was observed during functional testing.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.A complaint history examination for device component lots traceable to the reported lot number indicates there are three additional complaints associated with the component lots for the reported issue.The returned sample was found to be functionally conforming, therefore an actuation failure with abnormal noise as described in the complaint was not confirmed and a root cause cannot be determined for the complaint as described by the customer.No action was taken as the probe was functionally conforming.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Any non-concordances found are removed from the lot and scrapped.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No further actions are required.The manufacturer internal reference number is: (b)(4).

• Brand Name: CONSTELLATION VISION SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: cindy milam ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152231
• MDR Report Key: 8977695
• MDR Text Key: 157118885
• Report Number: 2028159-2019-01644
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TABLETOP-JAPAN
• Device Catalogue Number: 8065751817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/09/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2011
• 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