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 01/11/2016

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the lot specific to this event is not known; therefore, lot history and dhr reviews were not possible.The customer did not retain a sample for this complaint report; functional testing could not be conducted.The system vision system operator's manual provides the following in regard to loss of aspiration/suction issues: insufficient aspiration probable cause: 1.Loose blue luer fittings, 2.Damaged o-ring (ultraflow irrigation/aspiration handpiece only), 3.Clogged tip, 4.Kinked or damaged tubing, 5.Cracked blue fitting.Recommended solutions: 1.Reconnect securely, 2.Inspect o-ring and replace, as necessary, 3.Flush tip with sterile water or bss sterile irrigation solution.Retest.Replace tip.Retest, 4.Check tubing and/or replace fluidics module system (fms), 5.Check fitting and/or replace fms.The root cause of the customer's complaint could not be determined as a sample was not returned.Additional information has been requested but not received to date.(b)(4).

Event Description

A doctor of ophthalmology reported an aspiration issue during cataract surgeries with intraocular lens (iol) implant.Additional information has been requested but not received to date.This is one of two reports being filed for this facility.This report refers to the pool of events.

• 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: 5418868
• MDR Text Key: 37793683
• Report Number: 1644019-2016-00196
• 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
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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