Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON RESEARCH, LLC - IRVINE TECHNOLOGY CENTER CONSTELLATION VISION SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number TABLETOP
Device Problem Unexpected Shutdown (4019)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 turns off intermittently.No patient harm was reported.
 
Manufacturer Narrative
Based on information received following submission of the initial report, this event does not meet criteria for reporting as a device malfunction.The manufacturer internal reference number is: (b)(4).
 
Event Description
Additional information received from the customer indicated that there was no product problem, it was reported erroneously.A system message displayed indicating laser controller detected a port hardware failure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11070910
MDR Text Key224395908
Report Number2028159-2020-01146
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 foreign,other
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/24/2020
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? No
Date Manufacturer Received01/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-