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U.S. Department of Health and Human Services

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

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ALCON - IRVINE TECHNOLOGY CTR INFINITI VISION SYSTEM PHACOFRAGMENTATION SYSTEM Back to Search Results
Model Number INFINITI V3.0
Device Problems Device Operational Issue; System
Event Date 01/01/2014
Event Type  Malfunction  
Event Description

A customer reported that the phacoemulsification was not working properly. There are no further details. Add'l info has been requested.

 
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 add'l reportable info becomes available. (b)(4).

 
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Brand NameINFINITI VISION SYSTEM
Type of DevicePHACOFRAGMENTATION SYSTEM
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CTR
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECHNOLOGY CTR
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
janet moran
6201 south freeway
r3-48
fort worth , TX 76134
8176152742
MDR Report Key4239848
Report Number2028159-2014-02034
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type Other
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 10/03/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberINFINITI V3.0
Device Catalogue Number8065752160
OTHER Device ID Number3.02
Was Device Available For Evaluation? No
Date Manufacturer Received10/03/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2013
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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