MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT PHACOEMULSIFICATION

Model Number	BL3170
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned.Although no specific problem was reported, the ultrasound panel in the system has been replaced as a precautionary measure.A review of the device history record for the handpiece found that all physical and functional requirements.The investigation is ongoing.
Event or Problem Description
The user facility in italy reported that there was uncontrolled ultrasound discharge during cataract surgery.As soon as the surgeon began using the ultrasound, a sudden discharge appeared to be released, exceeding the maximum ultrasound setting (28), shattering the lens into many pieces.The next day, vitreoretinal surgery was performed on the patient to recover the nucleus pieces in the posterior segment of the eye.No further information about the patient.
Additional Manufacturer Narrative
One bl3170 stellaris handpiece, serial number (b)(6) was returned.Visual inspection found the nose cone dented.A functional test was performed using a stellaris system.The handpiece tuned, primed, and displayed good ultrasound function.In addition, the handpiece was correctly recognized as the handpiece data displayed the correct serial number for this handpiece.The handpiece data displayed tune count 36, on-time 3371704 and average power 0.However, the handpiece did not pass visual inspection due to the damaged nose.The cause of the damage cannot be determined.The handpiece was given to systems/controls engineer iii, in device development and systems/controls engineer ii of research and development for investigation.The complaint handpiece was ran through the network analyzer as well as through nominal stroke testing.All results check out as normal and equal when compared to a control handpiece.Impedance and frequency were well within our acceptance criteria and strokes were equal for all power levels.Noticed no overshoot or initial instability when operating like the complaint reported.If there was a realistic issue, it doesn¿t seem to be on the handpiece side.The device history was reviewed and found to meet manufacturing specification.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT PHACOEMULSIFICATION
• 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 ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22739428
• Report Number: 0001920664-2025-00093
• Device Sequence Number: 9120660
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)240702
• Combination Product (Y/N): N
• PMA/510(K) Number: K063331
• 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): 07/18/2025

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: BL3170
• 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: 07/18/2025
• Supplement Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS UNIT
• Patient Sex: Unknown