MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS PREMIUM PHACO PACK; UNIT, PHACOFRAGMENTATION

Model Number	BL5110
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device/particle was not returned for evaluation.A thorough review of the manufacturing records associated with this product has been performed and we have not identified any issues or discrepancies with these records.This investigation is ongoing.
Event or Problem Description
A user facility in france reported that three small metal wires came out of the ultrasonic handpiece.
Additional Manufacturer Narrative
The product and particle were not returned for evaluation so unable to investigate further for root cause.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.No corrective action required.
Additional Manufacturer Narrative
Udi related data quality updates only.The udi is being corrected due to a typographical error in the udi-di.

• Brand Name: STELLARIS PREMIUM PHACO PACK
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC.; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juli moore ; 3365 treecourt industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 18048422
• Report Number: 0001920664-2023-70118
• Device Sequence Number: 8077720
• Product Code: HQC
• UDI-Device Identifier: 10757770057013
• UDI-Public: (01)10757770057013(17)260611(10)X4562
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 10/03/2023

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: 06/11/2026
• Device Model Number: BL5110
• Device Lot Number: X4562
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 11/17/2023; 10/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ULTRASOUND HANDPIECE AND STELLARIS UNIT
• Patient Sex: Unknown