MAUDE Adverse Event Report: Bausch + Lomb, Inc. 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	08/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility in the united kingdom reported that the system switched off and back on in the middle of a procedure being performed.After restart all was okay.Surgeries continued with no further issues.Only a slight delay whilst system restarted.It was reported that there was no medical intervention/treatment required.
Additional Manufacturer Narrative
The product has not been returned.The system met specifications on the date of manufacture.The investigation of this event is in progress.A follow-up report will be submitted upon completion of investigation.

• Brand Name: Stellaris Elite PC w Laser 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 ; +1(636)226-3089
• MDR Report Key: 50855735
• Report Number: 0001920664-2026-00078
• Device Sequence Number: 9508655
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)20200120
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/20/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Stellaris system and accessories.
• Patient Sex: Unknown