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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 8065751832
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Code Available (3191)
Event Date 01/27/2017
Event Type  Malfunction  
Manufacturer Narrative

A review of the device history record indicates that the product was processed and released according to the product¿s acceptance criteria. A complaint history examination indicates there are no additional complaints associated with the lot for the reported issue. No sample has been returned for evaluation; therefore, the condition of the product could not be verified. No sample was returned and the device history record review of the lot number provided indicated product was released according to product¿s acceptance criteria; therefore, the root cause for the defect experienced by the customer cannot be determined. No specific action can be taken in regards to this complaint. All trocar blades are 100% inspected. All nonconforming product are removed from the lot and scrapped. Complaints are reviewed and monitored at regular intervals for any significant adverse trends. No additional action is required at this time. (b)(4).

 
Event Description

A pharmacy student reported observing the metal trocar disconnect from its plastic collar during removal of trocar plugs. The ophthalmic surgeon reassembled the two parts, replaced it on a spike and reattempted the sclerotomy. It was reported that the patient experienced major hypotony during the occurrence due to lack of infusion. 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 Key6329702
MDR Text Key67587239
Report Number1644019-2017-00159
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 02/14/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/14/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number8065751832
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 Received01/31/2017
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: 02/14/2017 Patient Sequence Number: 1
Treatment
CUSTOM-PAK SURGICAL PROCEDURE PACK
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