MAUDE Adverse Event Report: BAUSCH + LOMB STELLARIS ULTRASOUND HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number	BL3170
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 handpiece and consumables will not be returned for evaluation.A review of the device history record found that the serial number of the handpiece met all physical and functional requirements.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 is required.
Event or Problem Description
The user facility in the (b)(6) reported that an orange particle was found in the patient''s eye.The procedure was extended but how long was unknown since not timed.There was no additional anesthesia required and surgery was completed with no patient impact or clinical consequences.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• 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 ; 3365 tree court industrial blv; st. louis, MO 63122
• MDR Report Key: 14595629
• Report Number: 0001920664-2022-00080
• Device Sequence Number: 5811092
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)180515
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2022

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: BL3170
• Device Catalogue Number: BL3170
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BL5114 AND STELLARIS SYSTEM AND ACCESSORIES
• Patient Sex: Unknown