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

Model Number	BL11145
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in germany reported that during procedure, an error message indicating the cassette vacuum check failed was displayed.The surgery was stopped and the patient was transported to another clinic where the surgery was completed successfully.The patient's outcome is good.
Additional Manufacturer Narrative
The device was evaluated and it was found that the printed circuit board (pcb) was defective.A replacement is required.The device history record was reviewed and there were no nonconformities or anomalies related to this complaint.The investigation is ongoing.
Additional Manufacturer Narrative
The root cause of the cassette vacuum check failure was traced to a defective main pcb, which is responsible for controlling system functions including vacuum regulation and sensor feedback.The failure of the pcb led to an inability to complete the vacuum check, triggering a system lockout and preventing continued use during the procedure.The device responded as designed by entering a fault state and preventing use, which resulted in procedural interruption.The lot history, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The investigation is complete.
Event or Problem Description
Additional information received since the initial report.Local anesthesia was used during the procedure.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; saint louis, MO ; 6362263089
• MDR Report Key: 21575069
• Report Number: 0001920664-2025-00024
• Device Sequence Number: 8939936
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)190529
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: BL11145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2019
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown