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

Model Number	BL15455
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.The investigation is ongoing.
Event or Problem Description
The user facility in germany reported that when switching from phacoemulsification to posterior segment, the system's screen went black and would not start up again.After some time, the system worked and the procedure was completed.There was no significant delay in surgery and no additional anesthesia needed.The patient's outcome is good.
Additional Manufacturer Narrative
Dhr review for the unit manufactured on 04/03/2019 did not identify any evidence indicating the power supply (pn sps09848) was impacted.All required assembly steps and functional testing were completed with passing results.
Additional Manufacturer Narrative
The reported issue could not be duplicated during evaluation.The system functioned as intended and met all performance specifications.No evidence of a defect or abnormal condition was found; therefore, no further corrective action is warranted at this time.Product evaluation did not confirm the failure mode.Root cause could not be determined as the reported issue was not reproducible during evaluation and system testing.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 ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; rochester NY 14609
• Manufacturer (Section G): ST. LOUIS; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blv; saint louis, MO 63122 ; 636226-3089
• MDR Report Key: 23853122
• Report Number: 0001920664-2025-00127
• Device Sequence Number: 9959227
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)190403
• 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
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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: BL15455
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/16/2026; 01/26/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 01/27/2026; 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown