MAUDE Adverse Event Report: Bausch + Lomb Stellaris Elite Vision Enhancement System; Unit, Phacofragmentation

Model Number	BL11145
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported an influx of pressure.Due to high pressure when going from phaco to i/a resulted in an influx of fluid to the eye.The procedure was halted with workaround, but patient had to return to finish the surgery.No harm to patient.
Additional Manufacturer Narrative
The fluidics and compressor modules were replaced by the field service engineer on site.The module serial numbers (b)(6) and (b)(6) were evaluated with no evidence of condition that could or would lead to this complaint.The (b)(6) plungers worked as expected.The (b)(6) had no evidence of over pressurization, all compressor functional values were in specification.The field service engineer provided no evidence of reproducing complaint.The device history was reviewed and found to meet manufacturing specification.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 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 ; +1(636)226-3089
• MDR Report Key: 50457469
• Report Number: 0001920664-2026-00068
• Device Sequence Number: 10241442
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)210422
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown