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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 Problems Device Alarm System (1012); Break (1069); Difficult to Insert (1316); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2019
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.(b)(4).
 
Event Description
A customer reported that the fluidics module is broken, it did not work and the machine would not accept the cassettes.There was no error message displayed.There was no patient contact or impact.
 
Manufacturer Narrative
The initial decision to report was incorrect resulting in the initial report being submitted in error.This event is not considered to be a reportable malfunction, and it is not likely that a recurrence would result in serious injury.The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information received indicated that the machine was defective and did not accept the cassettes.
 
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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 Key8712756
MDR Text Key148786552
Report Number2028159-2019-01133
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 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/07/2020
Device Model NumberTABLETOP
Device Catalogue Number8065751150
Was Device Available for Evaluation? No
Date Manufacturer Received06/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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