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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON -IRVINE TECH CTR INFINITI VISION SYSTEM; PHACOFRAGMENTATION SYS
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ALCON -IRVINE TECH CTR INFINITI VISION SYSTEM; PHACOFRAGMENTATION SYS Back to Search Results
Model Number INFINITI V3.0
Device Problems Aspiration Issue (2883); Device Operational Issue (2914)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2014
Event Type  malfunction  
Event Description
A surgeon reported that during a procedure the ultrasound oscillation and aspiration was poor.Surgery was completed using the same system with no harm to the pt.
 
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 additional reportable information becomes available.(b)(4).
 
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Brand Name
INFINITI VISION SYSTEM
Type of Device
PHACOFRAGMENTATION SYS
Manufacturer (Section D)
ALCON -IRVINE TECH CTR
15800 alton pkwy.
irvine CA 92618 381
Manufacturer (Section G)
ALCON -IRVINE TECH CTR
15800 alton pkwy.
irvine CA 92618 381
Manufacturer Contact
janet moran
6201 s freeway
r3-48
fort worth, TX 76134
8176152742
MDR Report Key4278710
MDR Text Key21450627
Report Number2028159-2014-02206
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K112425
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2014
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/28/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2013
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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