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 a photo received from the reporter was performed.The photo shows a patient's eye with forceps pointing to a small, yellow, oval shaped particle in the eye.A review of the product specification sheet for the bl3124s irrigation sleeve found that the sleeve material is described as "yellow".The particle and the irrigation sleeve were not returned.A review of the device history record cannot be performed as the lot number was not provided.The investigation is underway.
Event or Problem Description
The user facility in france reported that during the 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 photo was sent to the vendor for evaluation.The vendor's investigation shows that a photo received from the customer shows a circular piece with light yellow color in the patient's eye, which matches the irrigation hole punch in yellow irrigation sleeves.A (scar) supplier corrective action request was opened by the supplier to address the reported issue on 18mar2024.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.The 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: 20847710
• Report Number: 0001920664-2024-00151
• Device Sequence Number: 3930130
• 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: 12/04/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown