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

Model Number TABLETOP-JAPAN

Device Problems Air Leak (1008); Device Inoperable (1663)

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

Event Date 12/27/2017

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

Event Description

A customer reported that actuation failure of the probe occurred and air bubbles came out from the probe during the procedure.The condition of aspiration is unknown.The procedure was completed without product replacement.There was no patient harm.

Manufacturer Narrative

A review of the device history records 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 indicates there were no additional complaints associated with the lot for the reported issue.The returned opened sample was visually inspected and deemed conforming.Cut testing was performed and deemed conforming.Actuation testing was performed and deemed nonconforming.Aspiration testing was and deemed nonconforming.Bubbles were not observed from the port during functional testing.The probe sample was disassembled and the components inspected.There is approximately 30 minutes of wear on the inner cutter when compared to the degree of wear based on continuous actuation of the probe visual standard photos.Gouge marks observed at the bend area and one other location along the inner cutter.The sample was tested with a syringe and resistance was not felt.A wire was inserted through the aspiration path.The sample was retested with a syringe and no resistance was felt.The sample was retested for actuation and aspiration with the probe driver and the both tests were deemed conforming.The initial actuation and aspiration tests failed due to an interference within the probe and once the interference was removed, the probe will then work properly.These tests are then considered conforming.The complaint evaluation does not confirm bubbles from the port since bubbles were not observed during functional testing.However, the complaint evaluation did confirm the probe had an actuation issue.Also, during the evaluation, the probe had an aspiration issue.The root cause for the actuation and aspiration issues is due to an interference within the probe that was removed during disassembly.The exact root cause of the interference cannot be determined from this evaluation; however, the interference most likely occurred from the probe being used in surgery for approximately 30 minutes.The interference could also be a root cause as to why the customer observed bubbles from the port ; however, bubbles could not be confirmed due to bubbles were not observed during the sample evaluation.No specific action with regard to this complaint was taken by the manufacturing location because the root cause of the reported issue of bubbles cannot be confirmed by this evaluation and the probe sample was manufactured to its specification for the reported actuation issue once the interference was removed.All probes are 100% visually inspected and tested for actuation, aspiration, and cut during manufacturing.Complaints will be continued to be reviewed and monitored at regular intervals for any significant adverse trends.(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: nadia bailey ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7189239
• MDR Text Key: 97661390
• Report Number: 2028159-2018-00107
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• 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: 4.00.168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2012
• 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