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U.S. Department of Health and Human Services

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

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ALCON RESEARCH, LTD. - HOUSTON CUSTOM-PAK SURGICAL PROCEDURE PACK GENERAL SURGERY TRAY (KIT) Back to Search Results
Catalog Number ASKU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994); Visual Impairment (2138)
Event Date 04/16/2016
Event Type  Injury  
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. The manufacturer internal reference number is: (b)(4).

 
Event Description

A nurse reported that a patient woke up with poor vision and pain in the left eye. The patient's left eye tested positive for a postoperative endophthalmitis with enterococcal species. The patient is still being seen by specialist. The surgeon does not have an opinion as to the cause of the endophthalmitis. Additional information has been requested.

 
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Brand NameCUSTOM-PAK SURGICAL PROCEDURE PACK
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
eddie darton, md, jd
6201 south freeway
mail stop ab2-6
fort worth, TX 76134
8175686660
MDR Report Key5687480
MDR Text Key46163637
Report Number1644019-2016-00844
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK880961
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/29/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/30/2018
Device Catalogue NumberASKU
Device LOT Number1862475H
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 Received05/04/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/16/2016
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: 05/29/2016 Patient Sequence Number: 1
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