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

Catalog Number 8065751763

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

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 the chamber was unstable during "chop mode" as he experienced an occlusion surge during vacuum during a cataract procedure.The product sample was retained.There was no known harm to the patient.Additional information was requested; however, none has been received to date.

Manufacturer Narrative

This is one of three complaints reported for this finished goods lot.All three of the complaints reported for this finished goods lot are for issues of this nature.A review of the device history records (dhr) indicated the order was built to specification.(b)(4) wet fms cassettes were returned for this complaint.The samples were visually inspected and no obvious defects were found; however, it was noted that the drain bags had been cut off of the samples in the returned condition.The samples were functionally tested and passed all aspects of functional testing.The samples could be recognized and the service data could be retrieved from the console.The samples primed and tuned successfully and reach maximum vacuum within specification.The irrigation and aspiration flow rates were within specification.No leakage occurred during functional testing.The root cause of the customer's complaint could not be established as the returned samples met specifications.After a thorough investigation of this complaint, it has been determined that no action will be taken at this time as the returned samples met specifications.(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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6146676
• MDR Text Key: 61722445
• Report Number: 2028159-2016-05537
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K121555
• 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: 03/20/2017

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 Catalogue Number: 8065751763
• Other Device ID Number: 2.04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: CENTURION FLUID MANAGEMENT PACK
• Patient Outcome(s): Other