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
Event or Problem Description
The user facility in the united kingdom reported a small particle was found in the patient's eye.The particle was removed from the patient¿s eye.There was no patient impact or clinical consequences.
Additional Manufacturer Narrative
A review of the device history record found that the serial number of the handpiece met all physical and functional requirements.The investigation is ongoing.
Additional Manufacturer Narrative
Correction to unique identifier (b)(4).One 3ml syringe was returned in a plastic bag.The handpiece was not returned.The syringe contained a piece of dried foam and a two-tone black and white particle.The particle was visible to the unaided eye and was stuck to the piston on the plunger rod of the syringe.The particle is approximately 1 millimeter in length and width.The particle is hard to the touch, and half of the particle is black while the other half is a white-ish color.The particle was sent to an external laboratory for analysis.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.This investigation is ongoing.
Additional Manufacturer Narrative
The particle was sent to an external laboratory for analysis.The particle was analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated that the white portion of the particle consists primarily of carbon.Lesser concentrations of oxygen and silicon were also detected.This is consistent with a silicon-containing organic material.Eds analysis indicated that the black portion of the particle consists primarily of iodine, silver, and carbon.Lesser concentrations of silicon, oxygen, sulfur, chlorine, and titanium were also detected.This is consistent with silver iodide and silicon-containing organic material.The particle was analyzed using a fourier transform infrared (ftir) spectrometer.The ftir analysis of both the white and black portions of the particle produced spectra is consistent with a combination of polydimethylsiloxane (pdms) and mucus.The laboratory results concluded that the white portion of particle consists primarily of polydimethylsiloxane (pdms) and mucus and that the black portion of particle consists primarily of silver iodide, mucus, polydimethylsiloxane (pdms), and mineral deposits.Materials from the white particle were not a composition of the bl3170 handpiece.Small traces (.11%) of titanium found from black particle which is a composition of the bl3170 handpiece.It cannot be determined if the particle originated from the unreturned bl3170 handpiece.Therefore, the root cause could not be determined.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.This investigation is complete.

• 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: 14316793
• Report Number: 0001920664-2022-00065
• Device Sequence Number: 4976257
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852(11)180326
• 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): 04/11/2022

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
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 07/15/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 06/21/2022; 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• 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
• Patient Sex: Unknown