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	04/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in taiwan reported during the first cataract surgery of the day, the system unexpectedly shut down.The nurse restarted it within approximately 3 to 5 minutes, and the surgery was able to proceed as planned.The system resumed normal operation without further issues.All subsequent surgeries were completed successfully, and no patients were adversely affected.
Additional Manufacturer Narrative
The field service technician on site could not duplicate the shutdown issue.The technician checked if the power cable was loose, performed a functional test and the unit passed.As a precaution the technician assisted in surgery to verify that the system is functioning properly.The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
Additional Manufacturer Narrative
The reported issue could not be duplicated during evaluation.The system functioned as intended following restart, and no anomalies were observed in subsequent operations.Without replication of the failure, the root cause remains undetermined.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 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: 22061370
• Report Number: 0001920664-2025-00069
• Device Sequence Number: 12672383
• Product Code: HQC
• UDI-Device Identifier: 00757770524532
• UDI-Public: (01)00757770524532(11)210121
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/25/2025

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: 04/25/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2021
• 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