MAUDE Adverse Event Report: BAUSCH + LOMB, INC. STELLARIS PC VISION ENHANCEMENT SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number	BL1433
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed, and it was found that this system met specifications at the time of manufacture.The product was not returned for evaluation rather a technician was dispatched to evaluate the system on site.The user interface computer was checked, as was the 24v line, and the electrical power stability.The reason for power interruption is the power supply.Power supply replacement is needed.The investigation is underway.
Event or Problem Description
The user facility in russia reports experiencing an unexpected power interruption two to four times a day.It was reported there was no medical intervention/treatment required.
Additional Manufacturer Narrative
The complaint was caused by power supply failure, resulting in interruption of electrical power to the unit.The technician replaced the faulty power supply module, verified all system parameters and functions returned to normal, and scrapped the old power supply locally.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 PC 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: 24873465
• Report Number: 0001920664-2026-00033
• Device Sequence Number: 21107216
• Product Code: HQC
• UDI-Device Identifier: 00757770497836
• UDI-Public: (01)00757770497836(11)120925
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: K101325
• 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): 04/14/2026

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: BL1433
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2012
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown