MAUDE Adverse Event Report: BAUSCH + LOMB VACUUM PHACO PACK WITH 2.2MM SLEEVE; UNIT, PHACOFRAGMENTATION

Model Number	BLV3220000
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned.The investigation is ongoing.
Event or Problem Description
The user facility in austria reported that during six procedures, white plastic particles entered the patient 's eye.There was no patient impact reported.This report is for the first patient.
Additional Manufacturer Narrative
The root cause could not be determined since the complaint sample was not available for evaluation.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Manufacturing and sterilization record were reviewed and found to be acceptable.The investigation is complete.

• Brand Name: VACUUM PHACO PACK WITH 2.2MM SLEEVE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 tree court industrial blv; saint louis MO 63122
• Manufacturer Contact: amy frutiger ; 6362263089
• MDR Report Key: 21766052
• Report Number: 0001920664-2025-00041
• Device Sequence Number: 18290572
• Product Code: HQC
• UDI-Device Identifier: 00757770058402
• UDI-Public: (01)00757770058402(17)260114(10)X6628
• Combination Product (Y/N): N
• PMA/510(K) Number: K063331
• 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): 03/13/2025

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 Expiration Date: 01/14/2026
• Device Model Number: BLV3220000
• Device Lot Number: X6628
• 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: 03/13/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DP8730S NEEDLES MICROFLOW 2.2 30 DEGREE; DP8730S NEEDLES MICROFLOW 2.2 30 DEGREE
• Patient Sex: Unknown