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

Model Number	BL14304
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported fluid stop flowing during vitrectomy.They changed disposable products and the handpiece and confirmed it is not a handpiece issue.Once they switched out the products they closed out of the current procedure on the screen and start a new one.It took about 10 minutes of troubleshooting.The patient was under general anesthesia and did not receive additional anesthesia time.By the time the infusion line was reestablished, there was bleeding and the procedure needed to be stopped.After following up with the surgeon, it did not sound like there was additional damage to the patient's eye, just that we were not able to complete the surgery.Currently this patient is not booked for another case.
Additional Manufacturer Narrative
The field service technician on site completed a system check and could not replicate issue.The reported issue of fluid flow interruption during vitrectomy ((b)(6)) could not be replicated during subsequent system evaluation.Following replacement of the handpiece, cartridge, and tubing, the team was able to restore functionality by closing the active procedure on the user interface and initiating a new one.This suggests the event was potentially related to a transient system state or software condition during the procedure.No mechanical or hardware failures were identified, and the system operated as intended under normal testing conditions.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 PC 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 ; 6362263089
• MDR Report Key: 23037142
• Report Number: 0001920664-2025-00104
• Device Sequence Number: 9455004
• Product Code: HQC
• UDI-Device Identifier: 00757770520251
• UDI-Public: (01)00757770520251(11)150325
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101325
• 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): 08/25/2025

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: BL14304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2015
• 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