MAUDE Adverse Event Report: BAUSCH + LOMB, INC 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	03/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product return requests have been made, however to date, the product has not been returned.The dhr review is complete with no anomalies noted.The investigation is ongoing.
Event or Problem Description
A user facility in the united kingdom reports that a piece of "metal" came out of the handpiece and into the eye.The surgeon was able to retrieve it.It was reported that there was no patient impact/injury.
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unknown.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.If the product is returned the investigation will be reopened at that time.The investigation is considered complete at this time.
Additional Manufacturer Narrative
The device was received in a plastic bag along with a small plastic specimen cup.The cup contained a sliver-like particle and a swab.The transducer horn was dented or nicked.A filter test was performed by injecting processed water through the irrigation tube on the side of the handpiece handle.The water was vacuumed off through a 0.45 micron filter in an attempt to trap any possible particles.Microscopic examination of the filter was performed.There were many dark colored particles, too many to count.None of the particles had the appearance of metal.Visual inspection of the plastic specimen cup found a shiny sliver-like particle stuck to the underside of the lid.Microscopic examination found that the sliver -like particle has a metallic appearance.The particle is at least 3761 microns long by about 67 microns wide.In addition, functional testing was performed using a stellaris system.The handpiece tuned, primed, irrigated and aspirated as intended.The handpiece displayed tune count 12, on-time 780816 and average power 1.Due to the damaged transducer horn the source and origin of the particle cannot be determined.An outside lab analyzed the particle using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).The particle consisted primarily of iron and chromium.Lesser concentrations of nickel, silicon, carbon, oxygen, and aluminum were also detected.This is consistent with series 400 stainless steel.The detected elements are not part of the handpiece construction.The root cause could not be determined.The investigation is complete.

• Brand Name: STELLARIS ULTRASOUND HANDPIECE
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): BAUSCH + LOMB, INC; 1400 n goodman st; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB, INC; 3365 treecourt industrial blvd; st. louis MO 63122
• Manufacturer Contact: juii moore ; 3365 tree court industrial blvd; st. louis, MO 63122 ; 6362263220
• MDR Report Key: 14166849
• Report Number: 0001920664-2022-00051
• Device Sequence Number: 17619429
• Product Code: HQC
• UDI-Device Identifier: 00757770480852
• UDI-Public: (01)00757770480852
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/23/2022

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
• 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: 03/23/2022
• Supplement Date Received by Manufacturer: 05/06/2022; 05/06/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/03/2022; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown