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

Model Number	BL14334
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A field service engineer checked the machine and found the wrong fluid level signal detected even when the cassette was empty.He was able to duplicate the error which did happen intermittently during testing.The camera sensor was replaced but the problem persisted.The module was replaced and will be sent back to the depot for investigation and repair.The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
Event or Problem Description
It was reported by the user facility in malaysia that the system was showing vfm14 during the procedure however fluid level in cassette was not full.Wrongly detected fluidic level even after a new cassette was inserted.The field service engineer reported that the system stopped unintentionally after the error.There was a minimal delay to restart and reinsert the cassette.No medical intervention or treatment was required.
Additional Manufacturer Narrative
The module was tested at the depot and failed wet operational testing given its contaminated aspiration transducer.Although initially near the maximum acceptable ad10 counts of 453-456, during dry testing, this value rose quickly above the absolute base level maximum (of 460) and did not recover to an acceptable state while moisture or moist air was present in the vacuum line.When in that disrupted condition, this module was attempting to "fail safe" given its conflicting data of already aspirating prior to irrigation, a disallowed condition, thus rejecting the cassette to prevent use during a fault.All four of the anchoring tabs for the cassette entry displayed some degree of cracking.Contamination of the aspiration transducer led to unstable ad10 readings in the presence of moisture, causing the system to detect false aspiration and enter fail-safe mode.The contamination likely developed over time following its 2015 manufacture and despite passing depot service in january 2025.Cracking of the cassette anchoring tabs may have contributed by allowing moisture or debris intrusion, compromising the transducer performance.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; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH & LOMB INCORPORATED; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: amy frutiger ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263089
• MDR Report Key: 22292074
• Report Number: 0001920664-2025-00078
• Device Sequence Number: 8319231
• Product Code: HQC
• UDI-Device Identifier: 00757770519996
• UDI-Public: (01)00757770519996(11)191115
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: BL14334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2015
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BL2213 PFM03015
• Patient Sex: Unknown