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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 LXT
Device Problem Partial Blockage (1065)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2019
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A customer reported that lot of bubble occurred after opening the infusion tubing head and bubbles occurred again when flushed using liquid when the gas-liquid change ended.No patient harm.
 
Manufacturer Narrative
Supplemental medical device report # 01, is being filed as it was determined that manufacturing report number 2028159-2019-00567 was a duplicate of mdr number 2028159-2019-00667.Additional information will be provided under manufacturer number 2028159-2019-00667.The manufacturer internal reference number is: (b)(4).
 
Event Description
New information from affiliate indicates that this report is a duplicate of a previous file.
 
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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 Key8509952
MDR Text Key142048835
Report Number2028159-2019-00667
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 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLXT
Device Catalogue Number8065751145
Was Device Available for Evaluation? No
Date Manufacturer Received04/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CONSTELLATION INFUSION SURGICAL SET
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