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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION
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BAUSCH + LOMB STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number BL2330
Device Problems Mechanical Problem (1384); Material Deformation (2976)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
While evaluating the system field service found the a capacitor burn on the phaco pcb.The pcb was replaced and the system tested and released for use.The device history record was reviewed and no anomalies were found.The investigation is ongoing.
 
Event Description
The user facility in malaysia reported they could not tune the handpiece and there was no coagulation.There was a burn smell during surgery.Error codes usm16 (us module fan has failed, can't be tuned or operated) and usm 10 (coagulation circuit may have failed) were displayed.The patient was converted to ecce (extracapsular cataract extraction).Surgery was completed successfully.
 
Manufacturer Narrative
The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is complete.
 
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Brand Name
STELLARIS PC VISION ENHANCEMENT SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
BAUSCH + LOMB
rochester NY 14609
MDR Report Key9468691
MDR Text Key171862283
Report Number0001920664-2019-00256
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 foreign,user facility
Type of Report Initial,Followup
Report Date 01/01/2005,11/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Model NumberBL2330
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
Initial Date Manufacturer Received 11/30/2019
Initial Date FDA Received12/13/2019
Supplement Dates Manufacturer Received01/15/2020
Supplement Dates FDA Received02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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