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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION
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BAUSCH + LOMB STELLARIS ELITE VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number BL2351
Device Problem Unexpected Shutdown (4019)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
A field service engineer visited the site to evaluate the system and was unable to duplicate the reported problem.They did tighten the can bus cable.The us voltage is normal.Firmware reset.Max vacuum pressure -692 mmhg.Vitrectomy 40,1 psi.The device history record was reviewed with no anomalies noted.The investigation is ongoing.
 
Event Description
The user facility in (b)(6) reported a system shutdown and cassette ejection during ultrasound fragmentation.The nurse reported the system did not reboot, they had to switch off the power entry module and then switch it back on.After that the power to the stellaris was normal.No patient impact has been reported.
 
Manufacturer Narrative
Multiple attempts to procure additional information regarding patient impact and outcome, have gone unreturned.We are unable to determine, the cause of the event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No further investigation or corrective action is necessary.
 
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Brand Name
STELLARIS ELITE VISION ENHANCEMENT SYSTEM
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
BAUSCH + LOMB
rochester NY 14609
MDR Report Key11020084
MDR Text Key238137788
Report Number0001920664-2020-00171
Device Sequence Number1
Product Code HQC
Combination Product (y/n)Y
PMA/PMN Number
K170052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBL2351
Was Device Available for Evaluation? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
STELLARIS SYSTEM AND ACCESSORIES
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