MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	BL2365
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer serviced the unit and could not reproduce the error.The computer was replaced and sent for further evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.A review of the trend analysis, risk assessment, and directions for use is underway.The investigation in ongoing.
Event or Problem Description
A user facility reported that the system shutdown during procedures.The system was rebooted and there was no reported patient impact.
Additional Manufacturer Narrative
A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is complete.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 20181905
• Report Number: 0001920664-2024-00113
• Device Sequence Number: 12942216
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)220614
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2024

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
• Operator of Device: Health Professional
• Device Model Number: BL2365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 09/10/2024
• Supplement Report FDA Received Date: 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/14/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown