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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065750833
Device Problems Disconnection (1171); Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/14/2019
Event Type  malfunction  
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).
 
Event Description
A nurse reported there was no phacoemulsification (phaco) power and the tray arm cover was disjointed.Timing of the event and patient impact are unknown.Additional information has been requested.
 
Manufacturer Narrative
Additional information is provided based on this information received following submission of the initial report, this event does not meet criteria for reporting as a malfunction.The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information has been received confirming prior to the cataract extraction procedure the system showed little ultrasound power even after having passed the ultrasound test.The handpiece was immediately exchanged which did not resolve the issue.The case was completed using an alternate system.There was no patient involvement.
 
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Brand Name
INFINITI VISION SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key8498895
MDR Text Key141909176
Report Number2028159-2019-00652
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
PMA/PMN Number
K120912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065750833
Was Device Available for Evaluation? No
Date Manufacturer Received04/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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