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

Model Number	BL11145
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in the united kingdom reported that during surgery, the system shutdown.There was no patient impact/injury.
Additional Manufacturer Narrative
A device history record review was performed.This system met specifications on the date of manufacture.The product was not returned rather a field service engineer visited the site to evaluate the system.They were unable to duplicate the reported issue.The system was plugged into a universal power supply when it powered off.Then the machine was plugged into a normal wall socket and continued without issue.The investigation of this event is ongoing.
Additional Manufacturer Narrative
The most probable root cause is unknown/inconclusive.The system powered off while connected to a universal power supply but functioned normally on a standard outlet.No issues found during service or testing.Likely due to external power source, not a system fault.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 is required.The investigation is complete.

• Brand Name: STELLARIS VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 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 63122 ; 6362263089
• MDR Report Key: 22065129
• Report Number: 0001920664-2025-00074
• Device Sequence Number: 7634486
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)210211
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 04/23/2025

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: BL11145
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Patient Sex: Unknown