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)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the (b)(6) reported that during phaco, small white particulate matter was ejected into the anterior chamber and then lodged into the irrigation port of the phaco probe causing the anterior chamber to collapse and stopping the irrigation flow.The particulate was removed from the patient's eye and the surgery was completed.There was no patient impact or clinical consequences.
Additional Manufacturer Narrative
The product has been requested but not yet received.A review of the device history record found that the serial number of the handpiece met all physical and functional requirements.At this time, no remedial, corrective, preventive, or field safety corrective action is required.The investigation is ongoing.
Additional Manufacturer Narrative
Correction: investigation findings code: removed 3221 and replaced it with 202.
Additional Manufacturer Narrative
The handpiece was not returned for evaluation, but the bl5114 disposable pack was returned for evaluation.One small plastic vial containing a light blue irrigation sleeve was received in a plastic bag.The original packaging was not received.The part number and lot number cannot be verified or determined.The irrigation sleeve was very dirty with particulates, saline dendrites, and dried solutions all over it.The tip of the sleeve was inverted.There were white-ish-cream colored particles visible in the sleeve, tip area, and inside the base of the hub area.The particles were removed and placed inside a petri-dish.The sleeve was cleaned and inspected.The tip was torn, and a small piece of the tip material has been torn off and was missing.Three particles were noted and white-ish in color.These particles are hard to the touch but break apart if pressure is applied.One particle did break into two pieces.Therefore, 4 particles are visible.The largest particle is approximately 3900 microns long x 2720 microns wide.These particles were taped to the bottom of the petri-dish and were sent to an outside lab for further analysis.The white particles were analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated that the white particles consist primarily of calcium.Lesser concentrations of phosphorus, sodium, oxygen, carbon, potassium, chlorine, and magnesium were also detected.This is consistent with calcium phosphate and saline residue.These materials are not used in the bl5114 product and the source of the returned particles cannot be determined.The trend analysis.Risk analysis, and/or directions for use were considered acceptable, with the product performing within anticipated rates.No corrective action required.

• 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: 14045753
• Report Number: 0001920664-2022-00045
• Device Sequence Number: 4775599
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)200429
• 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,Followup,Followup
• Report Date (Section B): 02/18/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2022
• Supplement Date Received by Manufacturer: 04/28/2022; 04/28/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/24/2022; 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2020
• 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, STELLARIS SYSTEM, AND ACCESSORIES.
• Patient Sex: Unknown