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	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The system was repeatedly observed to intermittently produce the screen glitch/flicker symptom over the period of 2.5 hours of monitored operation.The issue would appear under win 10 gui use and was also noticed during active bios access.The behavior was demonstrated more frequently after any cold start.A shutdown of the system was not seen during testing.Manipulation of the interface pcb's multiple cables triggered no discernable change in performance.Initially the unit booted to a "locked" state, requesting a password (which was not provided).The second and subsequent starts went through to completion, but access was still denied - password protected - when trying to establish the maintenance mode.The bios was inspected for an option to disable the password restriction, but that feature was found to be not selectable.A check for the peak component was made, with that part not being present.Cosmetically the product appeared in good condition, and its display stops proved fully operational.There was no prior depot activity for this assembly.The most probable root cause was traced to a component issue.The intermittent screen flicker was attributed to an internal hardware-related instability within the system assembly¿most likely associated with the display interface circuitry or related components on the interface pcb.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.This investigation is complete.
Event or Problem Description
The user facility reported the stellaris system screen glitched, went black, and system rebooted.This has happened on mulitple cases.Additional information for the multiple cases has been requested but not received.No patient impact was reported.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT SYSTEM
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 1400 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 ; saint louis ; 636226-3089
• MDR Report Key: 23498508
• Report Number: 0001920664-2025-00113
• Device Sequence Number: 8858289
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)241209
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• 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: BL11145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2024
• 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