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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-JAPAN
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2019
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 physician reported that during irrigation/aspiration, he mistakenly aspirated air together from root part of aspiration line and aspiration did not rise.The cassette was replaced and the procedure was completed.There was no patient harm.
 
Manufacturer Narrative
The lot complaint history was reviewed, this is the third complaint for the finish goods lot; however, the first for this issue for this lot.The device history record shows the product was released per specifications.The used sample was visually inspected.The drip chamber was cut off from the administration manifold.Replacing the administration manifold from the lab stock, the sample was tested using a calibrated console.The sample could prime and tune with the ultrasonic handpiece successfully.The irrigation and aspiration pressure were measured at multiple set points and met specifications.No message code appeared on the screen.The maximum value of vacuum and continuous reflux displayed properly on the progress bar.Fluid flowed from balanced salt solution (bss) to the drain bag without any interfering.No leakage was detected from the pump elastomer or on the pump area of the fluidics module.Cleaning process was able to be performed after functional test was completed.The sample passed functionality.The root cause of the customer's complaint could not be established; the returned sample functioned per specifications.After investigation of this complaint, it has been determined that this sample functioned per specifications; therefore, no corrective action is required at this time.Quality assurance has reviewed this complaint and will continue to monitor data for evidence of adverse trending and take further action, as appropriate.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 Key8795895
MDR Text Key151282309
Report Number2028159-2019-01291
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 10/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTABLETOP-JAPAN
Device Catalogue Number8065751817
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CONSTELLATION SURGICAL PROCEDURE PACK
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