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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CENTURION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065751763
Device Problem Failure to Shut Off (2939)
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 customer reported that the system settings were changing and the system would not shut down.Additional information has been requested.
 
Manufacturer Narrative
The system was examined and the reported event was not replicated.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa 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).
 
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Brand Name
CENTURION VISION SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key10289569
MDR Text Key199985577
Report Number2028159-2020-00542
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
PMA/PMN Number
K121555
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065751763
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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