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

Model Number	BL3170
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Eye Burn (2523)
Date of Event	09/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history was reviewed and found to meet manufacturing specification.This investigation is ongoing.
Event or Problem Description
The user facility reported a wound burn during a procedure.The surgeon used one suture to close and the next day the patient was doing fine.
Additional Manufacturer Narrative
The product evaluation has been completed.One bl3170 stellaris handpiece, serial number (b)(6) was returned with a blue label affixed to the handpiece.It was not a bausch & lomb label.Visual inspection found the nose cone and transducer horn bent.The wires are twisted inside the cable jacket and the lemo connector casing was bent.A functional test was performed using a stellaris system.The handpiece tuned, primed, and functioned as intended.Additionally, the handpiece was ran at 100% power for one full minute without irrigation or aspiration hook-up.The handpiece did not get hot to the touch during testing.The needle and tubing were not returned with the handpiece.Therefore, the complaint evaluation technician was unable to perform inspection and testing of the needle or tubing.We were unable to determine the root cause, but contributing factor may be the bent lemo connector casing.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 ULTRASOUND HANDPIECE
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 20779152
• Report Number: 0001920664-2024-00154
• Device Sequence Number: 18416172
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

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: BL3170
• 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: 11/13/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• 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