MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS I/A HANDPIECE SYSTEM; Unit, phacofragmentation

Model Number	BL3160
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and found to be dented on the rim.There is a fiber-like particle inside the tip insertion area of the handpiece.There are particles visible in the irrigation tube at the back of the handpiece as well.The investigation is ongoing.
Event or Problem Description
A user facility in france reported that particulates were detected during surgery.The particulates entered the patient eye and were removed.There was no patient impact.

• Brand Name: STELLARIS I/A HANDPIECE SYSTEM
• Common Device Name: Unit, phacofragmentation
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MICROSURGICAL TECHNOLOGY; 8415 154th avenue; redmond MO 98052
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18989510
• Report Number: 0001313525-2024-00075
• Device Sequence Number: 8203917
• Product Code: HQC
• UDI-Device Identifier: 00757770483488
• UDI-Public: (01)00757770483488(10)036396
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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: BL3160
• Device Lot Number: 036396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: I/A TIP 0.4MM CVD METAL 17.5G
• Patient Sex: Unknown