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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION

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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number TABLETOP
Device Problem Environmental Compatibility Problem (2929)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2020
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 healthcare professional reported that the main xenon lamp is out of order.Additional information has been requested however, further information has not been received.
 
Manufacturer Narrative
The company service representative examined the system and confirmed illumination issue in the event log.The company service representative replicated the illumination issue.The xenon lamp was replaced.The system was then tested and met all product specifications.Based on assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the nonconforming xenon lamp.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CONSTELLATION VISION SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key10240211
MDR Text Key198320615
Report Number2028159-2020-00493
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
PMA/PMN Number
K101285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTABLETOP
Device Catalogue Number8065751150
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/22/2020
Initial Date FDA Received07/07/2020
Supplement Dates Manufacturer Received08/27/2020
Supplement Dates FDA Received09/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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