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
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.
Additional Manufacturer Narrative
The device is in transit for evaluation.The investigation is ongoing.
Additional Manufacturer Narrative
The device was returned for evaluation and found a damaged o-ring, material missing, and particles all over.Some particles are fiber-like.The particles all visible all over the outer needle shaft, around the port and around the irrigation sheath.There is damage to the side of the tip with material missing.Particles are visible all around the rim of the irrigation ports, and around the tip of the irrigation sheath/sleeve and there are particles all around the o-rings.The investigation is ongoing.

• 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: 18838456
• Report Number: 0001313525-2024-70060
• Device Sequence Number: 7214984
• Product Code: HQC
• UDI-Device Identifier: 00757770483532
• UDI-Public: (01)00757770483532(10)171073
• 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,Followup
• 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: 171073
• 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
• Initial Report FDA Received Date: 03/05/2024
• Supplement 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