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

Catalog Number 8065751763

Device Problems Occlusion Within Device (1423); Unstable (1667)

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

Event Date 11/10/2016

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

A customer reported unstable anterior chamber, vacuum and occlusion surge during several eye surgeries.No patient harm was reported.Product samples have been requested for evaluation.

Manufacturer Narrative

A device history record ( dhr) review of the reported lot indicates that the order was built to specification.Seven wet, used fluidics management system (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 were cut off underneath the drain bag tape.The samples were functionally tested and samples 1 through 6 passed testing.Sample 7, failed to prime and generated a system message.No fluid flowed from the aspiration line to the cassette.The aspiration line was check for occlusions.The tubing was cut 27 inches from the luer insertion.Neither air pressure from the mensor, nor water from a syringe could purge the occluded silicone-like surgical debris.An aspiration manifold from the lab stock was used to complete functional testing on sample 7.The sample passed functional testing with the lab stock aspiration manifold.The root cause of this customer's complaint could not be established as six of the seven returned samples met specifications and the seventh sample initially failed priming due to occluded surgical debris, but passed with a lab stock aspiration manifold.It is possible that the surgical debris hardened in the tubing during transit.The sample passed functional testing with a lab stock manifold free of occluded surgical debris.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: rita lopez ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175514846
• MDR Report Key: 6144515
• MDR Text Key: 61709722
• Report Number: 2028159-2016-05501
• 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: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2017

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: 11/14/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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 PACK
• Patient Outcome(s): Other