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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LAUREATE WORLD PHACO SYSTEM; UNIT, PHACOFRAGMENTATION
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ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER LAUREATE WORLD PHACO SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Catalog Number 8065750502
Device Problem Intermittent Loss of Power (4016)
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.The manufacturer internal reference number is: (b)(4).
 
Event Description
A healthcare professional reported the system shuts down intermittently.This event happened prior to training in a wet-lab.
 
Manufacturer Narrative
The company service representative examined the system and was able to confirm and replicate the reported event.The company service representative found that the 3-pin top cable was loose.The company service representative reseated the cable.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 a loose 3-pin top cable.The manufacturer internal reference number is: (b)(4).
 
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Brand Name
LAUREATE WORLD PHACO SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER
15800 alton parkway
irvine CA 92618
MDR Report Key9853100
MDR Text Key186538740
Report Number2028159-2020-00251
Device Sequence Number1
Product Code HQC
Combination Product (y/n)N
PMA/PMN Number
K021566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065750502
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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