MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON CENTURION SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752200

Device Problem Aspiration Issue (2883)

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

Event Date 01/05/2016

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.Additional information has been requested and received.(b)(4).

Event Description

A doctor of ophthalmology reported no aspiration during a cataract surgery with intraocular lens (iol) implant.At first, the irrigation/aspiration (i/a) tip was changed without success.Then, the cassette was changed and the event resolved.The affected eye was the right eye (od).Per the surgeon the cassette contributed to the event.Additional information has been requested and received.

Manufacturer Narrative

Evaluation summary: review of the device history records indicated the order was built to specification.The customer did not retain a sample for this complaint report; therefore, visual inspection or functional testing could not be conducted.The root cause of the customer's complaint could not be established as a sample has not been received; however, complaints of a similar nature referencing aspiration/suction issues have been received and the most likely root cause is an error during the supplier¿s manufacturing process of the blue aspiration luer on the system manifold.It has been found that the blue luer on the manifold is not creating a complete seal resulting in air flow.

Event Description

Additional information provided.The decrease of aspiration occurred during irrigation/aspiration phase.Additional information has been requested and received.This is one of five reports being filed for this facility.This report refers to the event that happened on (b)(6) 2016.

Manufacturer Narrative

Evaluation summary: a review of the device history record indicated the order was built to specification.The customer did not retain a sample for this complaint report; therefore, visual inspection or functional testing could not be conducted.The system operator's manual provides the following in regard to loss of aspiration/suction issues: insufficient aspiration probable cause: loose blue luer fittings.Damaged o-ring (ultraflow irrigation/aspiration handpiece only).Clogged tip.Kinked or damaged tubing.Cracked blue fitting.Recommended solutions: reconnect securely inspect o-ring and replace, as necessary.Flush tip with sterile water or bss sterile irrigation solution.Retest.Replace tip.Retest.Check tubing and/or replace cassette.Check fitting and/or replace cassette.The root cause of the customer's complaint could not be established as a sample has not been received.Without a sample, it is not possible to isolate the root cause.

• Brand Name: CENTURION SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5390574
• MDR Text Key: 37043398
• Report Number: 1644019-2016-00125
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K880961
• 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,Followup
• Report Date: 04/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 8065752200
• Device Lot Number: 1764228H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 81