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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM

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ALCON - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM OZIL PHACOFRAGMENTATION SYSTEM Back to Search Results
Model Number INFINITI OZIL
Device Problem Aspiration issue
Event Date 04/19/2012
Event Type  Malfunction  
Event Description

A nurse reported an aspiration failure occurred during a procedure. There was no pt harm reported. Additional info was requested.

 
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Brand NameINFINITI VISION SYSTEM OZIL
Type of DevicePHACOFRAGMENTATION SYSTEM
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
paul nitschmann
6201 south freeway
r3-16
fort worth , TX 76134
8176152440
MDR Report Key2586323
Report Number2028159-2012-00749
Device Sequence Number1
Product CodeHQC
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/21/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberINFINITI OZIL
Device Catalogue Number8065750833
OTHER Device ID Number2.05
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer05/01/2012
Is The Reporter A Health Professional? Yes
Date Manufacturer Received04/20/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2008
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/21/2012 Patient Sequence Number: 1
Treatment
INTREPID BASIC PAK
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