MAUDE Adverse Event Report: BAUSCH + LOMB, INC. STELLARIS ELITE 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	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in france reported that the system shut down during phacoemulsification and while the eye was opened.The procedure was delayed by two hours and 30 minutes as a backup machine from another hospital was brought in.Additional local anesthesia was required.It was reported the patient's outcome is normal evolution to date.
Additional Manufacturer Narrative
A service engineer evaluated the system on site.It appears that the power socket on the assembly input panel caught fire, the cause is unknown.The input panel was replaced, and a full verification of the system was performed.All values were in range.The investigation is ongoing.
Additional Manufacturer Narrative
The device history record was reviewed.The product met specifications on the date of manufacture.The root cause of the input panel power socket overheating event could not be definitively determined.The most probable root cause is component issue, environment, unknown / inconclusive, user error.Product evaluation confirmed localized burning at the power socket on the input panel assembly; however, no specific component failure, manufacturing defect, or external condition could be identified.As a result, 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.The investigation is complete.

• Brand Name: STELLARIS ELITE 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: 23862866
• Report Number: 0001920664-2025-00136
• Device Sequence Number: 13085088
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)200401
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown