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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CTR INFINITI VISION SYSTEM OZIL; PHACOFRAGMENTATION SYSTEM
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ALCON - IRVINE TECHNOLOGY CTR INFINITI VISION SYSTEM OZIL; PHACOFRAGMENTATION SYSTEM Back to Search Results
Model Number INFINITI OZIL
Device Problem Device Issue (2379)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
A tech reported the system was having footpedal issues during a procedure.There was no impact to the pt.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 OZIL
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 Key4491518
MDR Text Key16851173
Report Number2028159-2015-00103
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082845
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 01/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2015
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 Number2.06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2008
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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