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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER INFINITI VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065750180
Device Problems Failure to Power Up (1476); Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2020
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 customer reported that the system turned off in between cases and never turned back on.There was no patient involvement.
 
Manufacturer Narrative
The company service representative examined the system was able to confirm the reported event.The nonconforming host module central processing unit (cpu) was replaced to address the issue.The system was then tested and met all product specifications.The system manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to the nonconforming host module central processing unit (cpu).The manufacturer internal reference number is:(b)(4).
 
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Brand Name
INFINITI VISION SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key10755439
MDR Text Key215096408
Report Number2028159-2020-00883
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
PMA/PMN Number
K120912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065750180
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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