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

Model Number	BL11114
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	10/22/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the veterinary system stopped suctioning during the case and would not aspirate any longer.There was no backup system on site.Initially, enough general anesthesia was administered to be able to complete both eyes.The left eye was completed, but the doctor believes a radial tear occurred due to the handpiece not aspirating correctly.For the right eye, the canine patient had to be woken, and due to their diabetes wait for about 6 hours to transfer to another facility.The patient was put back under general anesthesia at the other facility and the right eye was completed.Lenses were inserted in both eyes.
Additional Manufacturer Narrative
The product return has been requested.The device history record review was completed.The system met specifications on the date of manufacture.A field service technician was sent to the site to evaluate the system.The vacuum fluidics module was replaced.The removed module has yet to be received for evaluation.The investigation is underway.
Additional Manufacturer Narrative
The fluidics module was returned and evaluated.It failed to demonstrate any unintended cessation of its aspiration feature during two hours of attended use.The reported problem was not duplicated.This module's ad10 "vac trans" counts read acceptably and repeatably 400-401, from a cold start through wanned operation.The clear line from the cassette capture block to the aspiration transducer was free of surgical debris.The cassette interface was clean and only two minor, non-impacting, spots were present on the camera window.All of the red cassette level leds were functional as were those of the cassette illumination pcb, which itself was also uncontaminated.Curiously, the interior of this unit was erratically networked with some manner of fine webbing originating from an unidentified source.There had been no prior depot activity for this product.The parent system, (b)(6), was running at the 4.12 gui level, and a check of it constituent modules indicated no incompatibilities.The investigation continues.
Additional Manufacturer Narrative
No functional failure could be reproduced.The aspiration system operated normally with stable vacuum transducer readings, clean fluid paths, and no evidence of blockage, contamination, component malfunction, or system incompatibility.The reported issue could not be confirmed during attended testing.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 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: 23584008
• Report Number: 0001920664-2025-00121
• Device Sequence Number: 9641330
• Product Code: HQC
• UDI-Device Identifier: 00757770520190
• UDI-Public: (01)00757770520190(11)180404
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2025

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: BL11114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 01/09/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/19/2025; 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2018
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STELLARIS SYSTEM AND ACCESSORIES
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown