MAUDE Adverse Event Report: BAUSCH + LOMB 2.4 MM PHACO ACCESSORY PACK; UNIT PHACOEMULSIFICATION

Model Number	BL3124S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sleeve is not available, therefore an evaluation cannot be performed.A review of the device history record cannot be performed as the lot number was not provided.The investigation is ongoing.
Event or Problem Description
The user facility reported that during the procedure, a piece of the sleeve was in the patient's eye.There was no impact to the patient.
Additional Manufacturer Narrative
The sleeve is not available; therefore an evaluation cannot be performed.A review of the device history record cannot be performed as the lot number was not provided.The complaint description is consistent with the presence of an irrigation hole punch from the yellow irrigation sleeve associated with the device.The supplier opened a corrective action (scar) to address this issue on 18mar2024.The trend analysis, risk analysis and /or directions for use review were considered acceptable, with the product performing within anticipated rates.The investigation is complete.

• Brand Name: 2.4 MM PHACO ACCESSORY PACK
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 20883721
• Report Number: 0001920664-2024-00161
• Device Sequence Number: 7783615
• Product Code: HQC
• UDI-Device Identifier: 00757770059614
• UDI-Public: (01)00757770059614
• Combination Product (Y/N): N
• PMA/510(K) Number: K170052
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: BL3124S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown