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	12/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing and sterilization records were reviewed and found to be acceptable.One opened, used premium vacuum phaco pack with mics was returned with the cassette and tubing.No other content was returned.Visual inspection found the short spike shaft was attached to the bss bottle.There was fluid in the cassette, tubing and bottle which was filtered to extract any fm/particulates from the cassette and bottle.The particulates captured appear white/off white with a soft gel like consistency, and will be sent to a laboratory for further analysis.The investigation is ongoing.
Event or Problem Description
A user facility in the (b)(6) reports finding white matter present in their eye during the procedure.It was removed successfully.There no patient impact.
Additional Manufacturer Narrative
The lab analysis of particles from both the cassette and the bss bottle found them to consist primarily of mucus with lesser concentrations of saline residue.The particle samples were microscopically examined, photographed, and measured using a camera-equipped optical stereo microscope.The samples were analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope(sem) and a a fourier transform infrared (ftir) spectrometer.Eds analysis of the particle from the bss bottle indicated that it consists primarily of carbon.Lesser concentrations of chlorine, sodium, oxygen, sulfur, potassium, calcium, and phosphorous were also detected.This is consistent with organic material and saline residue.The ftir analysis of both particle samples produced spectra consistent with that of mucus.The source is unknown, and therefore the root cause is unknown/inconclusive.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 is required.The investigation is complete.
Additional Manufacturer Narrative
Correction h10: eds of the particle from the cassette indicated that it consists primarily of carbon and oxygen.Lesser concentrations of chlorine, sodium, calcium, potassium, and sulfur were also detected.This is consistent with organic material and saline residue.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: 13418912
• Report Number: 0001920664-2022-00012
• Device Sequence Number: 11968482
• Product Code: HQC
• UDI-Device Identifier: 20757770057546
• UDI-Public: (01)20757770057546(17)240822
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2021

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: 08/22/2024
• Device Model Number: BL5114
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• 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: 01/05/2021
• Supplement Date Received by Manufacturer: 03/26/2022; 01/05/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 03/19/2022; 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2021
• 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
• Patient Sex: Unknown