MAUDE Adverse Event Report: BAUSCH + LOMB I/A TIP 0.4MM CVD METAL 17.5G; Unit, phacofragmentation

Model Number	BL3165
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 for evaluation.There are particles all around the o-rings and on the outer surface of the tip and body.The irrigation sheath/sleeve is broken off and is missing.There are particles visible between the aspiration needle and what is left of the irrigation sheath/sleeve.There are particles in the aspiration port.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: I/A TIP 0.4MM CVD METAL 17.5G
• 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 WA 98052
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18989498
• Report Number: 0001313525-2024-00076
• Device Sequence Number: 11505549
• Product Code: HQC
• UDI-Device Identifier: 00757770483532
• UDI-Public: (01)00757770483532(10)171340
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951463
• 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: BL3165
• Device Lot Number: 171340
• 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: STELLARIS I/A HANDPIECE SYSTEM
• Patient Sex: Unknown