MAUDE Adverse Event Report: BAUSCH + LOMB MICROFLOW PHACO NDL 30DEG; UNIT PHACOEMULSIFICATION

Model Number	DP8230S
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility in the united kingdom reported the doctor noticed one particle while using the probe.The procedure was stopped and the particle was retrieved.The surgery continued and another particle appeared.The needle was changed to finish the procedure.They were unsure if the particles were from the probe/needle or from the handset.They have also taken the phaco handset out of use until further notice.The hospital kept handpiece and particles to be collected for evaluation.
Additional Manufacturer Narrative
The sterilization and lot history records were reviewed and found to be acceptable.This investigation is ongoing.
Event or Problem Description
Additional information: second surgery was not needed, the incision was not extended, and the time of surgery was not increased.No information about the patient outcome.
Additional Manufacturer Narrative
B5 additional information received.D4 correction: udi number.
Additional Manufacturer Narrative
Additional information: d10 concomitant products added.The lab report provided for the particles showed that the metal did not come from any of these devices.
Additional Manufacturer Narrative
One green microflow needle and two metallic-like particles were returned taped to a piece of gauze.The original packaging was not received.The part number and lot number cannot be verified or determined.Microscopic examination of the needle found that the hub and flats were heavily damaged.There was marring, gouges, scratches and missing material.Both particles have a metallic appearance.The first particle was 970 microns long by 594 microns wide.The second particle was 845 microns long by 842 microns wide.The particles were sent to an independent testing lab.The metallic particles were photographed using a camera-equipped stereo-optical microscope at 50x magnification.The particle was analyzed using an energy-dispersive spectrometer (eds) equipped scanning electron microscope (sem).Eds analysis of the particle indicated that it consists primarily of nickel.Lesser concentrations of carbon, oxygen, copper, sodium, silicon, and lead were also detected.Source/origin of particle could not be determined through lab analysis.

• Brand Name: MICROFLOW PHACO NDL 30DEG
• Common Device Name: UNIT PHACOEMULSIFICATION
• Manufacturer (Section D): BAUSCH + LOMB; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 3365 tree court industrial blv; st. louis MO 63122
• Manufacturer Contact: juli moore ; 6362263220
• MDR Report Key: 19583186
• Report Number: 0001920664-2024-00082
• Device Sequence Number: 15301873
• Product Code: HQC
• UDI-Device Identifier: 00757770056484
• UDI-Public: (01)00757770056484(17)281230(10)X5645
• Combination Product (Y/N): N
• PMA/510(K) Number: K954340
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/04/2024

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: DP8230S
• Device Lot Number: X5645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 06/24/2024; 07/25/2024; 08/23/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/12/2024; 08/21/2024; 08/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BL3160,BL3165,DP9730.I/A HANDPIECE+TIPS.4MM,90DG.; STELLARIS UNIT AND HANDPIECE.
• Patient Sex: Unknown