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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; 1
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; 1 Back to Search Results
Model Number TABLETOP
Device Problems Failure to Deliver Energy (1211); Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 the laser was not working prior to a surgical procedure.Additional information has been requested.
 
Manufacturer Narrative
The company service representative examined the system and was able to confirm the reported event in the event log of the system, but was unable to replicate the issue.The probe detector printed circuit board (pcb) was replaced as a preventive measure.The system was then tested and met all product specifications.The system was manufactured on may 18, 2015.Based on qa assessment, the product met specifications at the time of release.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
CONSTELLATION VISION SYSTEM
Type of Device
1
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key8359706
MDR Text Key137130836
Report Number2028159-2019-00262
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 company representative,foreig
Type of Report Initial,Followup
Report Date 05/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2019
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
Date Manufacturer Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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