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

Model Number	BL14455
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in china reported during phacoemulsification and intraocular lens implantation, the system experienced a negative pressure failure, triggering an alarm and system shutdown.Facility staff contacted the distributor¿s engineer who troubleshooted the fault remotely, causing the procedure to be paused for approximately 6 minutes.The gas pipeline was checked and the connections were readjusted.After restarting the system, the fault disappeared, and the surgery was successfully completed.There was no additional anesthesia required and no harm to the patient.
Additional Manufacturer Narrative
The facility connected with the distributor¿s engineer via video link, and the fault was troubleshooted remotely.The gas pipeline was checked and the connections were readjusted.After restarting the system, the fault disappeared.The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.

• Brand Name: STELLARIS ELITE PC SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 24964856
• Report Number: 0001920664-2026-00038
• Device Sequence Number: 10496525
• Product Code: HQC
• UDI-Device Identifier: 00757770524525
• UDI-Public: (01)00757770524525(11)240530
• Combination Product (Y/N): N
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: BL14455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2026
• Supplement Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2024
• 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