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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAUSCH + LOMB 25 GA. BI-BLADE CUTTER STELLARIS ELITE PACK; UNIT, PHACOFRAGMENTATION

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BAUSCH + LOMB 25 GA. BI-BLADE CUTTER STELLARIS ELITE PACK; UNIT, PHACOFRAGMENTATION Back to Search Results
Model Number SE5425WVB
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The user facility in france reported that a vitreotome had a malfunctioning guillotine.There was no impact to the patient and no medical intervention was required.
 
Manufacturer Narrative
Per the user facility, the product is not available for evaluation.Review of the device history records shows product was properly manufactured and met all release requirements.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.
 
Manufacturer Narrative
One opened pack was returned.Visual inspection found the needle bent, the port window in the opened position and dried solution on the cutter needle.The cutter looks used with fluid in the lines.The back cap is aligned correctly with the vent hole in the side of the cutter body.The connectors were inspected and no damage was found.A functional test was performed using a stellaris elite system.The cutter did not cut.The inner needle is binding up, preventing cutting and aspiration.It should be noted that a bent needle could contribute to poor cutting performance due to friction and binding between the inner and out needle assemblies.Due to the returned condition, and evidence of use, the root cause of the bent needle which can contribute to poor cutting could not be determined.We will continue to monitor for the reported complaint.
 
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Brand Name
25 GA. BI-BLADE CUTTER STELLARIS ELITE PACK
Type of Device
UNIT, PHACOFRAGMENTATION
Manufacturer (Section D)
BAUSCH + LOMB
1400 n goodman st
rochester NY 14609
Manufacturer (Section G)
BAUSCH & LOMB INCORPORATED
3365 tree ct. industrial blvd
saint louis MO 63122
Manufacturer Contact
juli moore
3365 tree court industrial blvd
st. louis, MO 63122
6362263220
MDR Report Key17975849
MDR Text Key326240967
Report Number0001920664-2023-70113
Device Sequence Number1
Product Code HQC
UDI-Device Identifier00757770059775
UDI-Public(01)00757770059775(17)240920(10)X4036
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K170052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSE5425WVB
Device Lot NumberX4036
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/20/2023
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
STELLARIS UNIT AND ACCESSARIES
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