MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ANTERIOR SYSTEM WITH AVS; UNIT, PHACOFRAGMENTATION

Model Number	BL11110
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in united kingdom reported the system shut down during a procedure.The system was rebooted and the procedure resumed with no further issues.There was no impact to the patient.
Additional Manufacturer Narrative
A field service technician evaluated the system.The system started up with no errors.The ac panel cable connection was found to be damaged and loose.After demonstrating the fault to the healthcare facility staff, the ac panel was replaced and passed testing.Preventative maintenance was performed on the system as well as field service test procedure.Final check of the system shows everything was within specification.The investigation is ongoing.
Additional Manufacturer Narrative
The malfunction was traced to a damaged and loose ac panel cable connection.Given the system¿s age (manufactured in 2013), normal wear and degradation of internal cable assemblies is the most likely contributor to the failure.Once the ac panel was replaced, all system checks passed and performance returned to specification, confirming the degraded cable connection as the root cause.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 ANTERIOR SYSTEM WITH AVS
• 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: 23487118
• Report Number: 0001920664-2025-00118
• Device Sequence Number: 18763847
• Product Code: HQC
• UDI-Device Identifier: 00757770480678
• UDI-Public: (01)00757770480678
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063331
• 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): 10/16/2025

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: BL11110
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2013
• 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