MAUDE Adverse Event Report: BAUSCH + LOMB 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure, component/assembly.Eic04735 [2024 manufacture (2.6/5.19.2)] had its recent history logfiles examined for evidence comparable to that of the reported issue.The case_sys07648_2025_10_14 corresponded closely to the communicated problem [note: system time reflected nov.1, 3:40 am at october 30, 1:40 pm cst as the unit was not communicating via an enabled gateway (which being win 10 could have provided accurate time correction)].This system reflected continued use, after the complaint, culminating in seven cases on 2025_10_17 (again, time correction to be considered).The physical state was good, with some drape adhesive on the front bezel and display.The action of the screen stops was positive and some dust had accumulated on the cooling fan blades.Touch response was positive and accurate to its calibration.This assembly did include the component referenced within sn (b)(6).Component-level failure within eic04735¿specifically the subcomponent called out in sn-fd-0110¿is the most likely root cause.The failure mode is intermittent component/assembly malfunction (eval code 1011) consistent with the logfile event.The device history was reviewed and found to meet manufacturing specifications.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.
Event or Problem Description
The user facility report the system shutdown after many error messages, (ex: wfc02, wfc09, eiv04, rcr04, vfm04), after unplugging and rebooting, the system was ok.The foot pedal was corded during this issue.No patient impact was reported.

• Brand Name: STELLARIS ELITE VISION ENHANCEMENT 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 ; 3365 tree court industrial blvd.; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 23488456
• Report Number: 0001920664-2025-00115
• Device Sequence Number: 16077082
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)240126
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown