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: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT 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
 

BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number BL2351
Device Problem Unexpected Shutdown (4019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The device history was reviewed and found to meet manufacturing specifications.Additional information has been requested.The investigation is ongoing.
 
Event Description
A user facility in libya reported that the system shutdown during surgery.The user rebooted the system but, it only worked for a few minutes before shutting down again.The surgery was completed without patient impact after restarting the system.The patient is in good health and the surgery was successful.
 
Manufacturer Narrative
There was no patient impact.The reporter restarted the system and completed the surgery.The patient is in good health and the surgery was successful.Additional information has been requested.
 
Manufacturer Narrative
There has been no service performed on this unit.Field service was waiting for advice from the customer.Though requested, no additional information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
STELLARIS PC VISION ENHANCEMENT SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
BAUSCH + LOMB
rochester NY 14609
MDR Report Key10620931
MDR Text Key209612869
Report Number0001920664-2020-00118
Device Sequence Number1
Product Code HQC
Combination Product (y/n)Y
PMA/PMN Number
K101325
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 01/01/2005,09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberBL2351
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Date Manufacturer Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-