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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LTD. / HUNTINGTON ACRYSERT DELIVERY SYSTEM LENS GUIDE

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ALCON RESEARCH, LTD. / HUNTINGTON ACRYSERT DELIVERY SYSTEM LENS GUIDE Back to Search Results
Catalog Number SN6CWS
Device Problem Inaccurate delivery
Event Date 07/26/2011
Event Type  Injury  
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Brand NameACRYSERT DELIVERY SYSTEM
Type of DeviceLENS GUIDE
Manufacturer (Section D)
ALCON RESEARCH, LTD. / HUNTINGTON
6065 kyle lane
huntington WV 25702
Manufacturer (Section G)
ALCON MANUFACTURING, LTD.
6065 kyle lane
huntington WV 25702
Manufacturer Contact
paul nitschmann
6201 south freeway, r3-16
fort worth , TX 76134
8176152440
MDR Report Key2468816
Report Number1119421-2012-00223
Device Sequence Number1
Product CodeHQL
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/24/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/31/2015
Device Catalogue NumberSN6CWS
Device LOT Number11065497
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/24/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2010
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: 02/22/2012 Patient Sequence Number: 1
Treatment
PROVISC
SN6CWS
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