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

Model Number BL3170

Device Problem Particulates (1451)

Patient Problem Endophthalmitis (1835)

Event Date 10/09/2023

Event Type  Injury  

Event 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.

Manufacturer Narrative

The device has not been received for evaluation.The investigation is ongoing.

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 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.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Type of Device: 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
• MDR Text Key: 327315553
• Report Number: 0001920664-2023-70119
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 0075777048085
• UDI-Public: (01)0075777048085(11)220819
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K063331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: BL3170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: STELLARIS UNIT.
• Patient Outcome(s): Hospitalization