MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ELITE PC W LASER 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	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During field service engineer investigation, the touchscreen became nonfunctional and could not be restored through touchscreen replacement.Subsequent loss of usb functionality was also observed, eliminating access to external input devices.These failures are consistent with an internal electronics issue, likely associated with the electronic interface controller (eic) or related circuitry.The system was removed from service and the eic was exchanged along with the power supply module.Complaint confirmed on the electronic interface controller (eic).Replacement of transition board, front bezel and damaged touch panel is required.Hard disk drive reimage required.Reported problem was not reproducible on the power supply module after being evaluated and in use for two days at the depot.The root cause was an internal hardware failure within the electronic interface controller (eic) or associated electronics, resulting in loss of touchscreen and usb input functionality.This failure led to loss of system operability and contributed to the reported system shutdown event.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.
Event or Problem Description
The user facility in france reported the system shut down during surgery.The surgeon switched to another stellaris system to complete the procedure.There was no patient impact.
Additional Manufacturer Narrative
The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.

• Brand Name: STELLARIS ELITE PC W LASER 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: 23838912
• Report Number: 0001920664-2025-00132
• Device Sequence Number: 9817166
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)220211
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 02/18/2026

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: BL15455
• 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: 11/27/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• 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