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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON CONSTELLATION SURGICAL PROCEDURE PAK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number ASKU
Device Problem Leak/Splash (1354)
Patient Problem No Code Available (3191)
Event Type  Malfunction  
Manufacturer Narrative

No lot number was identified with this complaint; therefore, lot history and complaint history reviews could not be conducted. No sample has been returned for evaluation; therefore, the condition of the product could not be verified. Due to an observed increased trend for this event, an internal investigation was initiated to determine if corrective and preventative actions were necessary. A root cause for the increased complaint rate was found to be related to a manufacturing post assembly inspection practice. This complaint does not identify a reported lot and no sample was returned for evaluation so it cannot be determined if the complaint can be attributed to the post assembly inspection. The post assembly inspection has been discontinued and an effectiveness check has been established and will be monitored periodically. (b)(4).

 
Event Description

An ophthalmic surgeon reported that the valved trocars leak infrequently causing loss of material from the vitreous cavity. It was reported that this prolongs the procedure and results in increased rate of suturing of the trocar port site. Additional information has been requested.

 
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Brand NameCONSTELLATION SURGICAL PROCEDURE PAK
Type of DeviceGENERAL 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
rita lopez
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175514846
MDR Report Key6419366
MDR Text Key70636187
Report Number1644019-2017-00271
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberASKU
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
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 TREATMENT DATA
Date Received: 03/20/2017 Patient Sequence Number: 1
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