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	02/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The handpiece will not be returned for evaluation.However, the particle is available.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.
Event or Problem Description
The user facility in the (b)(6) reported a white particle was found in the patient''s eye after phacoemulsification.The procedure was extended by approximately 0-15 mins.There was no patient impact or clinical consequences.
Additional Manufacturer Narrative
The particle was received and evaluated.It cannot be determined which product the particle came from.One plastic specimen cup was returned in a plastic bag.The original packaging was not received.The part number and lot number of the pack cannot be verified or determined.The specimen cup contains an unknown fluid and one white particle.The particle was removed from the specimen cup and placed in a petri-dish for microscopic examination.The particle is hard to the touch and is oddly shaped.The particle is approximately 1077 microns long by 736 microns wide by 336 microns deep.The particle was sent to an outside lab for further analysis.The particle sample was analyzed using an energy-dispersive spectrometer (eds) equipped with a scanning electron microscope (sem).Eds analysis indicated that the particle sample consists primarily of calcium.Lesser concentrations of phosphorus, carbon, and oxygen were also detected.This is consistent with calcium phosphate.This material is not a component of the handpiece and the source of this returned particle 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: 13826695
• Report Number: 0001920664-2022-00040
• Device Sequence Number: 4701946
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: 02/21/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 05/24/2022
• 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