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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 Operates Differently Than Expected (2913); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 Name
INFINITI VISION SYSTEM
Type of Device
PHACOFRAGMENTATION 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
MDR Text Key4990549
Report Number2028159-2014-02034
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112425
Number of Events Reported1
Summary Report (Y/N)N
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
1 Patient was 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
Patient Sequence Number1
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