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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CENTERINFINITI VISION SYSTEM OZILPHACOFRAGMENTATION 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.

 
Manufacturer Narrative

The customer's complaint history was reviewed for the period of one year; this is the first complaint reported for this issue. There have been no additional complaints reported against the finish goods lot and the dhr shows the product was released per specifications. The returned sample was visually and functionally tested and passed testing. The infiniti vision system operator's manual provides the following in regard to loss of aspiration: insufficient aspiration. Probable cause: loose blue luer fittings. Damaged o-ring (ultraflow i/a handpiece only). Clogged tip. Kinked or damaged tubing. Cracked blue fitting. Corrective action: reconnect securely. Inspect o-ring and replace, as necessary. Flush tip with sterile water or bss sterile irrigation solution. Retest. Replace tip. Retest. Checking tubing and/or replace fms. Check fitting and/or replace fms. The root cause of the customer's complaint is not known; the returned sample met specifications. (b)(4).

 
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Brand NameINFINITI VISION SYSTEM OZIL
Type of DevicePHACOFRAGMENTATION SYSTEM
Manufacturer (Section F)
ALCON - IRVINE TECHNOLOGY CENTER
15800 alton pkwy.
irvine CA 92618
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
(817) 615 -2440
Device Event Key2628977
MDR Report Key2586323
Event Key2483016
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
Was The Report Sent To Manufacturer? No
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
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

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