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

Catalog Number 8065751763

Device Problem Air Leak (1008)

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

Event Type  malfunction  

Manufacturer Narrative

Product samples have been received and are awaiting evaluation.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 surgeon reported inability to build vacuum as well as bubbles in the aspiration line "specially during the phaco portion" of an unknown quantity of cataract procedures.Additional information was requested for this report.Upon follow up it was informed that the procedures were completed without replacing the products and without harm to the patients.Product samples were requested for evaluation.

Manufacturer Narrative

Six wet and used cassette samples were returned in trays for this complaint.Two of the six samples were randomly selected for visual and functional testing.The drain bags were detached from the cassette covers due to saturation.Both of the tested samples could be recognized and the service data could be retrieved from the console.The samples primed and tuned successfully; however, leakage occurred between the aspiration luers and the handpiece during the tuning process.The cavity of the aspiration fitting was 3 on both samples.The aspiration fittings were replaced with lab aspiration fittings and the tuning process was repeated.No leakage was observed during the re-tuning of the samples.Both samples were able to reach a maximum vacuum within specification.The irrigation and aspiration flow rates were within specification.No drops presented from the irrigation luers after the irrigation off 5 seconds.Neither leakage, nor occlusion was detected from the tubing insertion to the fittings and the four aspiration ports on the pump region of the cassette bases.Although the samples were able to reach maximum vacuum with no issues, leakage form the blue aspiration luer was observed on the returned samples.It has been determined that some of the blue luers from one of the six supplier cavities (cavity 3) from one supplier lot can allow air to enter the aspiration line and reduce the ability of the sample to reach maximum vacuum.An internal investigation has been opened to address reports of a similar nature.In regards to the console, no further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.A phaco handpiece was received for evaluation.A device history record shows that the product met specifications at the time of release.A visual assessment of the returned sample found no visual defects.A full functional test was then performed on the returned handpiece.The handpiece was first tested on a ground resistance tester in which it passed and the handpiece was then connected to a calibrated system for priming and tuning.The handpiece was found to pass all functional testing on the system and was then tested on the dynamic tuning fixture (dtf) for stroke testing on both ultrasound and torsional movements.Functionally the handpiece passes all tests.The phaco handpiece was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.(b)(4).

Manufacturer Narrative

The returned samples for the lots associated with the customer's report were visually and functionally tested and passed testing.The samples were able to reach a maximum vacuum within specification.The aspiration fitting cavity was found to be cavity 3.No leakage was observed at the blue aspiration luer.A device history record shows that product met specifications at the time of the release.The root cause of the customer's complaint could not be established as the returned sample met specifications.An internal investigation has been opened to address reports of a similar nature.(b)(4).

• Brand Name: CENTURION 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: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5407779
• MDR Text Key: 37748315
• Report Number: 2028159-2016-00465
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/10/2016

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 Catalogue Number: 8065751763
• Other Device ID Number: 02.01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/19/2016; 05/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2013
• 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