MAUDE Adverse Event Report: BAUSCH + LOMB, INC STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE; UNIT, PHACOFRAGMENTATION

Model Number	BL5114
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has not been returned.The manufacturing and sterilization records were reviewed and found to be acceptable.The investigation is ongoing.
Event or Problem Description
A user facility in (b)(6) reported that during the phaco phase of cataract removal and phaco, a small white foreign body was expelled into the eye from the tubing.The surgeon was able to aspirate and collect the particle.It is unknown if the foreign body came from within the tubing or the balanced salt solution (bss) bottle.The bss bottle details are not available.It was discarded by staff.There was no patient injury.
Additional Manufacturer Narrative
Device return is anticipated but has not yet occurred.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 has been deemed necessary.
Additional Manufacturer Narrative
One plastic vial came in a plastic container, in a plastic bio hazard bag.No other content was returned.Visual inspection found a small white piece of foreign material/particulate in the container.Microscopic inspection revealed a small white object that looks somewhat translucent.The white object feels soft to the touch when grasped with tweezers.It was sent be sent to a lab for further evaluation and identification.The lab performed an analysis using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis indicated that the white particle consists primarily of carbon.Lesser concentrations of titanium and oxygen were also detected.This is consistent with organic material and titanium dioxide pigment.The white particle was also analyzed using a fourier transform infrared (ftir) spectrometer.The ftir analysis of the white particle produced a spectrum consistent with that of polystyrene.The result indicates the material is consistent with polystyrene with titanium dioxide tint.Bl5114 product is packaged in tray made with high impact polystyrene tinted a bluish white, but the source of the returned particle cannot be definitively determined due to the manner in which this particle was returned with no other components, limitations of analytical testing, and the many potential sources of this resin widely used in the medical field.The most probable root cause is unknown/inconclusive.The investigation is complete.

• Brand Name: STELLARIS PHACO PREMIUM PACK WITH MICS NEEDLE
• 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: juli moore ; 3365 tree court industrial blvd; st. louis, MO 63122
• MDR Report Key: 12720643
• Report Number: 0001920664-2021-00144
• Device Sequence Number: 3855956
• Product Code: HQC
• UDI-Device Identifier: 20757770057546
• UDI-Public: (01)20757770057546(17)240507
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2021

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 Expiration Date: 05/07/2024
• Device Model Number: BL5114
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• 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: 10/11/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 01/25/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 12/20/2021; 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSS
• Patient Sex: Unknown