MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	BL3170
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Endophthalmitis (1835)
Date of Event	10/09/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility in france reported that milky fluid was released from the handpiece during surgery causing anterior chamber disorders and poor fluid dynamics (lack of aspiration).The handpiece was replaced with a new one to complete the procedure.The surgery was prolonged, however additional anesthesia was not required.No issues were noted on day 1 post-op.The patient is currently hospitalized for acute post-operative endophthalmitis.
Additional Manufacturer Narrative
The device has not been received for evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
The device was received and evaluated.There were no external visual defects noted.A functional test was performed using a stellaris system.The handpiece data displayed tune count 19, on-time 1455892 and average power 0.The handpiece tuned, primed, and functioned as intended.The device history record was received and there were no nonconformities or anomalies related to this complaint.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.The root cause of the reported event could not be determined.
Event or Problem Description
Additional information was received after the initial report.The patient had a functional loss of the eye: monocular.The post-operative endophthalmitis was treated with corticosteroids.
Additional Manufacturer Narrative
Udi related data quality updates only.The udi is being corrected due to a typographical error in the udi-di.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 18067618
• Report Number: 0001920664-2023-70119
• Device Sequence Number: 7759437
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)220819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/12/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: BL3170
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 01/04/2024; 10/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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 UNIT.
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown