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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 Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/01/2020
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A surgeon reported that iop compensation did not activate during an ocular procedure.Patient harm was not reported.Additional information has been requested.
 
Manufacturer Narrative
Additional information has been provided in b.5.The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information was received indicating that the issue occurs randomly.It occurs at the beginning, in the middle or at the end of the procedure.Iop compensation is activated but shuts itself off during the procedure for several seconds.This is noticed by the surgeon when the eye becomes soft.The surgeon discontinues suction and then the iop compensation reactivates on its own.Hypotony lasts a few seconds.There have been no long-term clinical consequences.
 
Manufacturer Narrative
The company service representative examined the system.The company service representative confirmed system message (sm) [infusion flow data invalid: iop control functions will be disabled.Check infusion tubing for air bubbles] in the event log which is consistent with the reported issue.The fluidics module was replaced as a prevention.Unrelated to the reported event, the company service representative adjusted the tray arm due to it being blocked.The system was then tested and met all product specifications.Additional information received from company service representative, the issue was found to be random.However, the system has been found to have no problem after multiple checks.The system manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The customer did not return the cassette for evaluation.The cassette manufacturing device history record (dhr) was reviewed.Based on assessment, the product met specifications at the time of release.The system was found to meet specifications.Therefore, the root cause of the reported event cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).
 
Event Description
Further information was received indicating that priming was completed before the procedure began.There is no indication of the tubing being kinked, modified or taped to something.No blockages or flow issues were observed with tubing.
 
Manufacturer Narrative
Additional information has been provided in b.5, d.4, e.1 and h.4.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 Key9803523
MDR Text Key186153848
Report Number2028159-2020-00209
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,Followup,Followup
Report Date 07/21/2020
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 02/12/2020
Initial Date FDA Received03/07/2020
Supplement Dates Manufacturer Received05/26/2020
06/15/2020
07/16/2020
Supplement Dates FDA Received06/22/2020
07/13/2020
07/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CONSTELLATION PROCEDURE PAK
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