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

Model Number	BL11145
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Corneal Ulcer (1796)
Date of Event	02/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The system met specifications on the date of manufacture.The module has been returned, but has yet to be evaluated.The investigation is underway.
Event or Problem Description
The user facility reported that during cataract surgery the cassette overfilled.The customer replaced the cassette, and vacuum check failed messages persistently occurred.The customer stated that it seemed like the cassette filled much faster than it should have.The lens in the right eye was successfully implanted, however the surgery on the left eye could not be started.The case was prolonged 1-1.5 hours while the customer attempted to get the machine running and contact a representative and technical support.Excess fluid in the veterinary patient's left eye, which will be managed with medications until system is available for corrective surgery.The right eye visual, normotensive, intraocular lens in place, with moderate uveitis.Left eye cataractous and nonvisual.Excess fluid in the left eye was managed with the following medications: neomycin polymyxin dexamethasone topically q6h, prednisolone acetate 1% topically q6h, dorzolamide/timolol topically q6h, ofloxacin topically q6h, atropine topically q12h, cyclosporine 1% topically q12h (concurrent keratoconjunctivitis sicca), optixcare eye lubricant topically q12h, amoxicillin/clavulanic acid po q12h, carprofen po 12h, gabapentin po q12h, vetsulin (diabetic patient) also worth mentioning, this patient developed a 4mm x 6mm ovoid superficial corneal ulcer within the first week post-operatively, which we are now treating.It is unclear if this is related to complications with our stellaris, but with the prolonged duration of the procedure (even with diligent corneal irrigation) the customer feels it is important to note.
Additional Manufacturer Narrative
The reported problem was not duplicated the compressor in test system passed vacuum check 20 times in succession without any messages indicating an issue and reached 660 mmhg 19 out of 20 times.No balanced salt solution was observed in this module.This compressor would not cause overfilling on the test system used in depot and the fluidics module was sent to site but returned unused leaving the original fluidics module in system.Most probable root cause is unknown/ inconclusive and remains undetermined.Evaluation did not reproduce the reported issue, and available testing indicates the compressor was functioning as expected, making it an unlikely cause.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; 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: 24619711
• Report Number: 0001920664-2026-00025
• Device Sequence Number: 9585845
• Product Code: HQC
• UDI-Device Identifier: 00757770524495
• UDI-Public: (01)00757770524495(11)181213
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 03/17/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS DISPOSABLES AND ACCESSORIES.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown