MAUDE Adverse Event Report: BAUSCH + LOMB, INC. 2.4 MM PHACO ACCESSORY PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL3124S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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
A user facility in france reported that during a procedure, a piece of the sleeve was in the patient's eye.It was removed intraoperatively with no impact to the patient.
Additional Manufacturer Narrative
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 were considered acceptable, with the product performing within anticipated rates.No corrective action required.This investigation is complete.

• Brand Name: 2.4 MM PHACO ACCESSORY PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC.; 4100 n. goodman st.; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 tree court industrial blvd; saint louis, MO 63122 ; 6362263220
• MDR Report Key: 20860523
• Report Number: 0001920664-2024-00150
• Device Sequence Number: 21015074
• 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
• 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
• 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: 12/06/2024
• Supplement Report FDA Received Date: 01/13/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown